List of Peptide Therapies Companies with Phase 2 Active Clinical Trial - 48

Our strategy is to develop pharmacologically optimized drug candidates, which are first assessed in healthy volunteers and patients as monotherapy prior to their use in combination regimens designed to achieve improved treatment outcomes in patients. Our initial areas of focus are viral and liver diseases where our team can leverage their in-depth knowledge and expertise to develop potentially best-in-class combination regimens for each disease area with significant unmet medical need.

Altimmune is a clinical stage biopharmaceutical company focused on developing intranasal vaccines, immune modulating therapies and treatments for liver disease. Our diverse pipeline includes proprietary intranasal vaccines for COVID-19 (AdCOVID™), anthrax (NasoShield™) and influenza (NasoVAX™); an intranasal immune modulating treatment for COVID-19 (T-COVID™); and next generation peptide therapeutics for NASH (ALT-801) and chronic hepatitis B (HepTcell™). P

Alzamend Neuro, Inc., a preclinical stage biopharmaceutical company, focuses on developing products for the treatment of neurodegenerative diseases and psychiatric disorders. The company’s lead product candidate is AL001 for the treatment of Alzheimer’s and other neurodegenerative diseases and psychiatric disorders. It is also developing AL002, a cell-based therapeutic vaccine, which seeks to restore the ability of the patient’s immunological system to Alzheimer’s. The company was incorporated in 2016 and is headquartered in Tampa, Florida.

Aravax is a clinical stage biotechnology company developing a novel peptide-based immunotherapy, PVX108, for the treatment of peanut allergy. Aravax is striving to improve the lives of patients living with peanut allergies by developing a therapy that precisely targets the underlying cause of disease, bringing benefits in safety and convenience.

Arch works closely with the scientific community, universities and research institutions to advance and build the value of select medical innovations, develop the most promising intellectual property, and create value for its investors. The company holds a strong patent portfolio of new drug candidates to prevent inflammation and organ injury. Arch’s Phase I and Phase II clinical trials led to LSALT peptide (Metablok), being the first novel therapeutic to join the Canadian Treatments for COVID-19 trial, a multi-centre adaptive, randomized, open-label, controlled clinical trial involving fifty-five hospitals across Canada. • Arch scientists described a novel mechanism of action for organ inflammation in the journal Cell. • Arch scientists identified the enzyme dipeptidase-1 (DPEP1) as a major neutrophil (white blood cell) adhesion receptor in the lungs, kidneys and liver. • DPEP1 was shown to be the target of LSALT peptide (Metablok), the Company’s lead drug candidate targeting inflammation in the lungs and kidneys. Arch is currently working to advance LSALT peptide through the production of additional human safety and efficacy data in a Phase II trial to prevent IRI-acute kidney injury (AKI). Please follow the company on LinkedIn, and subscribe at the website for the latest science and investor news.

AsclepiX Therapeutics is focused on transforming the treatment of ocular diseases through the rapid clinical development of groundbreaking therapies aimed at empowering patients and their families around the world with the freedom to live their best lives. Using pioneering computational biology methods, we have identified multiple families of peptides that are potent regulators of vascular homeostasis. Our clinical candidates are derived from these peptides and work through naturally existing, highly evolved, and self-regulating mechanisms of homeostasis that maintain our health and well-being.

Aston Sci., a clinical stage biopharmaceutical company that is currently focusing on clinical development of innovative medicines in oncology, immunology, and geriatrics, including therapeutic cancer vaccines. Aston Sci. is constantly listening to the changing needs of the patients and will continue to move forward to improve the lives of patients who suffer from cancer recurrence, metastasis, or side effects during cancer treatment.

Axoltis pharma is a biopharmaceutical company dedicated to develop a first-in-class disease-modifying drug to treat patients with neurodegenerative or traumatic neurological disorders with high unmet medical needs. Our innovative approach: combining Preventative, Neuroprotective, Regenerative & Remodeling properties in a single drug, as the key to cure complex neurological disorders. Our products are first-in-class multifunctional peptides with high potential in many CNS disorders.

Basking is developing the first in class agent (BB-031) targeting von Willebrand Factor (VWF) along with a direct acting reversal agent (BB-025) to immediately the pharmacological effect of BB-031 in the event of bleeding. BB-031 is an RNA aptamer optimized for rapid onset of action and short duration of effect. Basking will initiate a Phase 2 trial in acute ischemic stroke in late 2023 and is exploring further application in pulmonary embolism in preclinical studies. The technology is based on two decades of translational research on RNA aptamers as therapeutic agents for cardiovascular diseases.

BRIM is a clinical-stage company developing novel peptide treatments for hard-to-treat diseases. BRIM’s first-in-class assets are based on its innovative stem cell regenerative PDSP technology platform, which has the potential to be effective in multiple therapy areas and indications.

Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious fungal or viral infections. The Company’s portfolio is comprised of new approaches aimed at transforming existing treatment and prevention paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to antiviral conjugates (AVCs) targeting influenza and other viral diseases from Cidara’s proprietary Cloudbreak® antiviral platform.

Corteria Pharmaceuticals - FOCUSED ON THE DEVELOPMENT OF TRANSFORMATIVE THERAPIES FOR THE TREATMENT OF WORSENING AND ACUTE DECOMPENSATED HEART FAILURE Founded in 2021, Corteria Pharmaceuticals is a privately held company developing first-in-class drugs for indications of high unmet medical need, such as heart failure, sarcopenia and obesity subpopulations. Our strategy implies innovative patient stratification and target selection based on human evidence and a better understanding of the disease biology in patients. We are using cutting-edge methods to stratify the patients and identify those who will benefit the most from our treatments. Our focus is on worsening and acute heart failure, right heart failure, sarcopenia (including age-related sarcopenia and obesity-related sarcopenia) and obesity with established complications.

Dong-A ST is a company established in March 2013 following the restructuring of the former Dong-A Pharmaceutical into a holding company. Our company focuses on the development and sale of specialized pharmaceuticals (ETC) and is dedicated to the philosophy of "Our company's social contribution is in new drug development." With state-of-the-art research facilities such as the Yongin Research Center established in 1977 and the completion of the Songdo Research Center in 2021, Dong-A ST has been striving for innovative global new drug development with excellent research and development capabilities. For many years, by consistently investing more than 10% of its revenue in R&D, we have successfully developed multiple proprietary novel drugs, including Stillen, Zydena, Motilitone, Sivextro, and Suganon/Sugamet.

Dynavax is a fully-integrated biopharmaceutical company focused on leveraging the power of the body’s innate and adaptive immune responses through Toll-like Receptor (TLR) stimulation. Dynavax develops, and commercializes novel vaccines.

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH (1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.

Eusol Biotech was founded in March 2005 in Taipei, Taiwan. The company is involved in the R&D and GMP process development of recombinant human acid fibroblast.

Extend Biosciences is a biotechnology company that focuses on enabling technologies for the efficient and sustained delivery of peptides and proteins.

Since 2008, GemVax & KAEL has operated as a cutting-edge research and development company developing proprietary peptide drug, GV1001, for treatment against various cancers and neurodegenerative disease including Alzheimer's disease and Progressive Supranuclear palsy. The fundamental driving purpose of our innovative pharmaceutical research is to facilitate significant improvements to human life through the introduction of advanced medical technology and innovation rooted in advanced scientific measures. At GemVax, we take pride in our proactive approach to medical research, and our progressive peptide-drug focused advancements have played a crucial role in the incessant global battle against incurable disease.

ImmunoForge is a biopharmaceutical company that specializes in developing targeted cancer agents for conditions like sarcopenia and rare mutations including BCR-ABL, T315I, RET, and FGFR4.

InflammX Therapeutics, Inc. is targeting inflammasome mediated and recycling inflammation, and providing a therapeutic effect to both eyes simultaneously. They have a pipeline focused on ophthalmic treatments and have submitted an IND amendment to enable clinical studies with orally dosed Xiflam, their NLRP3 inflammasome targeting program in retinal and kidney disease.

Inotrem is a biotechnology company specialized in immunotherapy for acute inflammatory syndromes, such as septic shock. Founded in 2013, with offices in Paris and a technology center in Nancy (France), the company has developed a new concept of immunomodulation that targets the TREM-1 pathway to control unbalanced inflammatory responses. Leveraging its proprietary technology platform, Inotrem has developed the first-in-class TREM-1 inhibitor, nangibotide, with applications in a number of therapeutic indications such as septic shock or myocardial infarction. Next to acute inflammatory syndromes, Inotrem is also developing a program targeting chronic inflammatory diseases.

Korro Bio was founded to turn extraordinary scientific insights into life-altering new treatments for patients. We harness the body’s natural RNA editing machinery to make precise, single-base RNA edits to modulate protein function, addressing the medical needs of patients. Our mission is to rewrite the future for patients living with debilitating disease by repairing the underlying genetic cause.

Lutris Pharma is a clinical stage biopharmaceutical company focused on improving anti-cancer therapy effectiveness and quality of life for patients who are being treated with EGFR (Epidermal Growth Factor Receptor) inhibitors or with radiation, where dermal toxicity often leads to a reduction of anti-cancer therapy compliance. The company aims to provide novel topical therapies in order to mitigate these side effects. Lutris Pharma’s lead asset, LUT014, a topical B-Raf Inhibitor, is a proprietary, first-in-class, small molecule currently in a phase 2 clinical trial in metastatic colorectal cancer patients with EGFR inhibitor induced acneiform lesions and a phase 1/2 study for the treatment of radiation-induced dermatitis.

Lytix Biopharma is a clinical-stage immuno-oncology company developing novel cancer immunotherapies, an area within cancer therapy that is aimed at activating the patient’s immune system to fight cancer. Lead compound LTX-315 provides access to antigens by using the patient’s own tumor as source of antigens and turns cold tumors hot. Local treatment with LTX-315 targets the first step in the cancer immunity cycle with a potential cornerstone position in immunotherapy.

MBX Biosciences, Inc. is a clinical stage biopharmaceutical company pioneering investigational Precision Endocrine Peptides (PEPs™). PEPs are designed to overcome key limitations of native peptide therapeutics to deliver superior pharmacologic properties. MBX is advancing a pipeline of PEP candidates to address the unmet needs of people with endocrine disorders. The company’s lead product candidate, MBX 2109 for the treatment of hypoparathyroidism, is currently in a Phase 1 clinical trial. Members of MBX’s leadership team have collaborated over several decades on the discovery, development, and commercialization of highly successful endocrine therapeutics including Forteo® and Humalog®. The company is supported by leading life science investors including Frazier Life Sciences, New Enterprise Associates and OrbiMed.

Metsera is a clinical-stage biopharmaceutical company accelerating the next generation of medicines for obesity and metabolic diseases.

Our vision, to disrupt cancer with the development of highly innovative immunotherapies aimed at increasing patient survival rates MimiVax is a privately held, clinical-stage biotechnology company focused on the development and commercialization of immunotherapeutic vaccines and targeted therapies for the treatment of cancer. SurVaxM, our lead immunotherapeutic vaccine, has completed a Phase 2a clinical trial in adults with newly diagnosed glioblastoma.

NervGen is a publicly traded (TSX-V: NGEN, OTCQX: NGENF) clinical stage biotech company dedicated to discovering and developing innovative treatments for nervous system damage, due to injury or disease. NervGen’s lead drug candidate, NVG-291, is a first of its kind experimental drug administered by injection under the skin. NVG-291 relieves the inhibitory effects of CSPGs and thus enables nervous system repair. In animal studies, this therapeutic approach promoted nervous system repair and enhanced recovery of functions such as walking, bladder control, vision, and memory. NVG-291 entered Phase 1 clinical trials in 2021. After completing our Phase 1 clinical trial, we plan to study the effectiveness and safety of NVG-291 initially in people with spinal cord injury, Alzheimer’s disease and multiple sclerosis.

ONL Therapeutics (ONL) is a clinical-stage biopharmaceutical company committed to helping patients see the future. Our mission is to develop innovative therapeutics to protect and improve the vision of patients with a range of retinal disease and conditions. By advancing a breakthrough technology designed to prevent the death of key retinal cells caused by the activation of the natural Fas pathway, ONL is pioneering an entirely new approach to preserve sight. It is the first and only company focused on preventing Fas-mediated death of key retinal cells, which is a root cause of vision loss, a leading cause of blindness and an unaddressed medical need. ONL’s lead therapeutic candidate, ONL1204, is a first-in-class small peptide Fas inhibitor designed to protect retinal cells from both death and inflammatory signaling pathways. ONL1204 Ophthalmic Solution is being developed for the treatment of retinal detachment, an acute condition for which the company has been granted orphan drug designation by the FDA. In addition, the company is currently developing ONL1204 in geographic atrophy associated with age-related macular degeneration, glaucoma, and other acute and chronic indications.

OrthoTrophix is focused on the development and commercialization of revolutionary therapies that offer new solutions to the unmet medical needs of patients suffering from diseases and conditions involving hard tissues. OrthoTrophix believes that its product candidates have distinct advantages over existing therapies. The Company’s most advanced project is TPX-100, a candidate first-in-class disease modifying osteoarthritis drug (DMOAD). OrthoTrophix has successfully demonstrated safety and clinical efficacy of TPX-100 in a Phase 2 placebo-controlled study in subjects with knee osteoarthritis in fifteen centers across the U.S. Other joint degenerative conditions such as post-traumatic arthritis and rheumatoid arthritis are potential additional target indications for TPX-100. OrthoTrophix is a private company operating in the San Francisco Bay Area, incorporated by its three founders in May 2011. OrthoTrophix has raised over $30 million in partnering revenues and equity financing since inception.

Over the course of millions of years, nature evolved to create the world’s most awe-inspiring, life-changing health outcomes. Peel Therapeutics translates these evolutionary outliers to develop medicines for patients with cancer and inflammatory diseases. Using scientific and medical expertise, state-of-the-art technology and drug development knowledge, we redesign what nature offers into medicines for patients by tackling solubility, scalability, and bioavailability. Our clinical stage therapeutic pipeline treats a spectrum of devastating conditions, with a near-term focus on cancer and inflammation. At Peel Therapeutics, we push the limits of biology to develop highly effective and safe medicines for patients that transcend the incremental.

PepGen Inc., a clinical-stage biotechnology company, focuses on the development of oligonucleotide therapeutics for use in the treatment of severe neuromuscular and neurologic diseases. Its lead product candidate is PGN-EDO51, an EDO peptide that id in Phase I clinical trial to treat individuals with Duchenne muscular dystrophy (DMD). The company is also developing PGN-EDODM1, an EDO peptide-conjugated PMO, which is in Phase 1 clinical trial for the treatment of myotonic dystrophy type 1, as well as EDO therapeutic candidates, such as PGN-EDO53, PGN-EDO45, and PGN-EDO44 for the treatment of DMD. PepGen Inc. was founded in 2018 and is headquartered in Boston, Massachusetts.

Peptomyc is a company focused on the development of a new generation of cell penetrating peptides (CPPs) targeting the Myc oncoprotein for cancer treatment. The company was founded in December 2014 and it is based on Dr. Soucek’s scientific research on Omomyc (the best direct Myc inhibitor known to date) over the last twenty years.

Phoenix Nest Biotech is a biotechnology company that focuses on treating Sanfilippo Syndrome by collaborating with leading academics and utilizing licensed key technologies.

PYC Therapeutics (ASX: PYC) is a clinical stage biotechnology company pioneering a new generation of RNA therapeutics for genetic diseases. It works by combining two complementary platforms: RNA-based drug design and PYC’s proprietary drug delivery technology. PYC's library of naturally derived cell penetrating peptides provide its delivery platform to overcome the major challenges of RNA therapeutics - getting into the target cell. PYC believes its PPMO (Peptide conjugated Phosphorodiamidate Morpholino Oligomer) technology enables a safer and more effective RNA therapeutic to address the underlying drivers of a range of genetic diseases for which no treatment solutions exist today. The Company is leveraging its leading-edge science to develop a pipeline of novel therapies including two programs focused on inherited eye diseases and preclinical discovery efforts focused on neurodegenerative diseases. PYC’s discovery and laboratory operations are located in Australia, and the Company’s preclinical and clinical operations are based in San Fransisco California.

Radiopharm Theranostics is developing a world-class platform of radiopharmaceutical and nuclear medicine products for both diagnostic and therapeutic applications. The company is focused on innovating the way we see and treat cancer, with a particular emphasis on HER-2 cancers. Radiopharm Theranostics has a strong team of executives and board members, and is actively engaged in investor relations and corporate governance. The company has also launched a joint venture with MD Anderson to focus on novel radiopharmaceuticals.

ReAlta Life Sciences is a biotech company that focuses on rebalancing the inflammatory response to address life-threatening acute inflammatory and rare diseases with their EPICC peptides based on the human astrovirus research.

Rein Therapeutics is a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Rein's lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. LTI-03 is anticipated to initiate a Phase 2 clinical trial in the first half of 2025 for the treatment of idiopathic pulmonary fibrosis. Rein's second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the U.S. and E.U. and Fast Track Designation in the U.S. For more information, please visit www.reintx.com or follow us on Twitter at @Rein_Tx.

ResoTher Pharma is a privately held biotechnology company located in Copenhagen, Denmark. The company is focused on discovering and developing novel peptide-based drugs to treat neutrophil-driven inflammation (resolution therapy). ResoTher Pharma has received a grant from the European Innovation Council (EIC) to support a phase 2a clinical study of their lead candidate RTP-026 for myocardial infarction.

At Sapience, we think boldly about the possibilities for treating cancer. We aim to discover and develop peptide therapeutics to address oncogenic and immunogenic dysregulation that drive cancer. Our pipeline of SPEARs™ (Stabilized Peptides Engineered Against Regulation) disrupt intracellular protein-protein interactions, enabling targeting of transcription factors which have traditionally been considered undruggable. We are advancing our lead programs, ST316, a first-in-class antagonist of β-catenin, and lucicebtide (formerly known as ST101), a first-in-class antagonist of C/EBPβ, through Phase 2 clinical trials. Please engage with us on this platform to learn more!

SpliSense Ltd., is a growing and exciting biotechnology company, developing novel therapies for genetic diseases by inhalation. The company is currently focusing on splicing mutations in the CFTR gene for treating Cystic Fibrosis (CF) patients.

TearSolutions Inc. is a Delaware Corporation based in Charlottesville, VA. The company has successfully completed a well-powered 204 patient Phase II Proof of Concept clinical trial for the treatment of ocular surface disease in primary Sjögren’s Syndrome patients. Statistically significant improvement in both sign and symptom at two weeks was found. The trial compared vehicle and two doses of LacripepTM, a novel 19 AA peptide that is present in normal tears and deficient in all forms of dry eye. The peptide restores homeostasis to the ocular surface, in particular the barrier function of the corneal epithelium and normal function of sensory nerves at the corneal surface in preclinical animal models. Restoration of epithelial barrier function can be measured clinically as a decrease in corneal fluorescein staining while the improvement in sensory nerve function restores normal production of the components of tears: the aqueous via reinnervation of lacrimal glands, the lipid via reinnervation of meibomium glands and the mucin via reinnervation of goblet cells. Improvement in fluorescein staining and tear production (Schirmer tear test) are clinical ‘signs’ of ocular suface disease that have been used in the FDA approval of Xiidra and Restasis, respectively. Lacripep was discovered at the University of Virginia with NIH National Eye Institute funding as a naturally occurring fragment of the larger 119 AA protein, lacritin, in an unbiased screen for novel factors capable of addressing dry eye.

Terns Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, develops small-molecule single-agent and combination therapy candidates for the treatment of non-alcoholic steatohepatitis (NASH) and other chronic liver diseases. It develops TERN-101, a liver-distributed and non-bile acid farnesoid X receptor agonist, which is in Phase 2a clinical trial for the treatment of NASH; and TERN-201, a vascular adhesion protein-1 inhibitor that is in Phase 1 clinical trial for the treatment of NASH. The company also develops TERN-501, a thyroid hormone receptor beta agonist with enhanced liver distribution and metabolic stability; and GLP-1R, a small-molecule Glucagon-Like Peptide-1 receptor agonist program that is intended to address metabolic processes involved in the pathogenesis of NASH. Terns Pharmaceuticals, Inc. was founded in 2016 and is headquartered in Foster City, California.

Vico Therapeutics is committed to advancing RNA modulating therapies for patients with severe, genetic neurological disorders. Vico is initially targeting spinocerebellar ataxia types 3 and 1 and Huntington’s disease. Our VICOMER platform designs antisense oligonucleotides for various genetic defects by modulating or editing RNA.

We are leading a new era of precision medicine in which rationally designed oligonucleotides are the key to delivering safer, more effective medicines. These include potentially transformational therapies for conditions where there are currently few or no treatment options. We aspire to help create a world in which every patient with a genetic disease will have access to life-changing treatments in their lifetime.

Windtree Therapeutics is a global, clinical-stage, biopharmaceutical and medical device company focused on the development of novel therapeutics intended to address significant unmet medical needs in important acute care markets. Windtree has four clinical and multiple pre-clinical programs spanning respiratory, cardiovascular and oncology disease states. The Company’s lead clinical programs include AEROSURF®, a novel med-device combination designed to deliver the company’s proprietary synthetic, peptide-containing surfactant non-invasively to premature infants with respiratory distress syndrome (RDS); istaroxime, a first-in-class, dual-acting agent being developed to improve cardiac function in patients with acute heart failure while avoiding the unwanted side effects of existing treatments; and rostfuroxin, a novel precision medicine targeting hypertensive patients with certain genetic profiles focused on the large and important resistant hypertension market. In all we do, we are driven by compassion and the aspiration to help patients and their families realize the hope they have for a life less impacted by disease.

Xinnate is a young biopharmaceutical company built on groundbreaking scientific research about innate defence and healing mechanisms – evolutionary biological systems with the purpose of keeping us healthy. One of these innate defence peptides has shown to be an effective ”natural” and unique way of preventing infection as well as reducing excessive inflammation. Xinnate specializes in the development of proprietary peptide-based drugs for prevention and treatment of inflammatory diseases and infections within the areas skin and wounds, surgical materials and and biomaterials. The company was founded in 2019 and is based on 15 years of world class research from Lund University. The first area to be addressed by Xinnate is advanced wound care, and the first product is a hydrogel, the BioC wound gel, aimed for treatment of burn wounds.

Zucara Therapeutics, a CDRD and MaRS Innovation portfolio company, is developing the first drug therapy to prevent hypoglycemia in people with diabetes. Our first-in-class therapeutic is focused on improving glucagon counterregulation by inhibiting somatostatin which is dysregulated in Type 1 diabetes. Preventing hypoglycemia will dramatically change diabetes disease management, improving both patient health and quality of life..