List of Microbiome Companies with Phase 3 Active Clinical Trial - 24

Aardvark Therapeutics is a clinical stage biopharmaceutical company focused on leveraging host adaptive responses through gut-brain signaling for the treatment of metabolic and inflammatory diseases. The company has multiple programs in its pipeline and has received FDA orphan drug designation for its novel drug candidate for Prader-Willi syndrome.

Axial Therapeutics™ is a clinical-stage biopharmaceutical company focused on the discovery and development of gut-restricted, small molecule therapeutics for central nervous system (CNS) disorders. The company is leveraging its expertise in the gut-brain axis and its unique drug development platform to advance novel therapies that have the potential to transform the treatment paradigm in neurodegenerative diseases.

BGI was founded in 1999 as a research organization to support the Human Genome Project. Over the years, BGI’s in-house research has contributed to the development of the field of Genomics in significant ways, as evidenced by a wealth of peer-reviewed publications in prestigious scientific journals. Today, BGI is actively participating in the fields of Cancer Research, Bio-sustainability and Personalized Medicine through a global network of collaborators. BGI Genomics is the world’s leading provider of genomic and proteomic services, now serving customers in more than 66 countries. We provide academic institutions, pharmaceutical companies, health care providers and other organizations with integrated genomic and proteomic services and solutions across a broad range of applications spanning basic and translational research, drug discovery, agriculture and health care. To provide these services, we operate a large network of service Laboratories in China, Hong Kong, the US and Europe. Our customers benefit from the highest level of sequencing experience in the world to support their research and drug discovery projects. Our service laboratories operate under strict internationally recognized quality systems, such as those from CAP and ISO. More recently, BGI developed and launched its own DNBseq™ sequencing technology, based on DNA Nanoball sequencing technology that was invented in our Complete Genomics research facility in Silicon Valley, California. Scientists around the world now rely on DNBseq NGS services for the highest quality data at the lowest cost.

BIOHM optimizes digestive health by combining good bacteria, good fungi and enzymes to break down digestive plaque, allowing for total gut balance. This allows BIOHM's 30 billion live active cultures to maintain, support, and promote the balance of the total microbiome in the digestive system.

Carbiotix is an award-winning biotechnology company pioneering the onsite upcycling of plant-based side-streams. Carbiotix mission is to improve the health of people by increasing the consumption of prebiotics and other active ingredients from upcycled side-streams. Carbiotix offers one core service today called NutraCycle, an on-site upcycling and fortification service allowing food & beverage, ingredient, and feed producers to turn plant-based products into healthier, more profitable, and sustainable products.

Bridging the gap between disruptive discovery products and real-world patient reach, we identify high-potential compounds for in-licensing, we conduct clinical development and then select large pharmaceutical commercialization partners for out-licensing to maximize patient access across the globe. Through this specialized business model, Debiopharm can focus on the development of prescription drugs that target unmet medical needs in oncology and bacterial infections. Debiopharm completed the development and has licensed out 2 compounds: - Triptorelin, the active substance of Decapeptyl®/Trelstar®/Pamorelin®/Triptodur® 1, 3 and 6-month formulation and Moapar®/Salcacyl® -Oxaliplatin, the active substance of the branded Eloxatin®/Elplat®/Dacotin®/Dacplat® If your university or biotech start-up has interesting molecules in early-stage research and you’re seeking a competent and committed partner to develop them further, please contact us!

Freya™ is a clinical-stage company taking an innovative approach to women’s health, with microbial immunotherapies aimed at relieving the chronic inflammation underlying a range of reproductive system diseases uniquely afflicting women.

Infant Bacterial Therapeutics AB (IBT) is a pharmaceutical company dedicated to developing drugs that prevent diseases in premature infants and combat the spread of antibiotic-resistant illnesses. IBT’s primary focus is on IBP-9414, a drug candidate containing Lactobacillus reuteri, a bacterial strain found in breast milk. The aim of IBP-9414 is to reduce the occurrence of necrotizing enterocolitis (NEC) and improve sustained feeding tolerance (SFT) in premature infants. Currently, IBP-9414 is undergoing a pivotal Phase III study for registration. IBT also has other drug candidates, including IBP-1016 for treating gastroschisis, IBP-1118 for preventing retinopathy of prematurity (ROP), and IBP-1122 for eliminating vancomycin-resistant enterococci (VRE) causing hospital acquired infections. By developing these drugs, IBT addresses medical needs that lack available treatments.

KoBioLabs is recognized for its international level of microbiome therapeutic technologies. In particular, our researchers have a distinctive position in the microbiology field globally with their presence in the ongoing International Human Microbiome Consortium [IHMC].

Lumen Bio is a clinical-stage biotechnology company developing topically and mucosally delivered biologic drugs to treat and prevent highly prevalent diseases.

MaaT Pharma has established the most complete approach to restoring patient-microbiome symbiosis to improve survival outcomes in life-threatening diseases. Committed to treating blood cancers and graft-versus-host disease, a serious complication of allogeneic stem cell transplantation, MaaT Pharma has already achieved proof of concept in acute myeloid leukemia patients. Supporting the further expansion of our pipeline into larger indications, we have built a powerful discovery and analysis platform to evaluate drug candidates, determine novel disease targets and identify biomarkers for microbiome-related conditions. Our therapeutics are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome. MaaT Pharma benefits from the commitment of world-leading scientists and established relationships with regulators to spear-head microbiome treatment integration into clinical practice.

Founded in 1895, Nexira is a family owned company who built its reputation as the world leader in acacia gum. Today Nexira is a global leader in natural ingredients and botanical extracts for food, nutrition, and dietary supplements. Our ingredients are perfectly suitable for the formulation of clean label products. Nexira manufactures in France a wide range of natural ingredients with recognized health benefits, such as Fibregum™ an all-natural, organic and GMO-free source of soluble dietary fiber. Nexira's portfolio for food industry includes a large range of branded natural acacia gum ingredients with exceptional functional properties (Emulsifiers & stabilizers, coating agents, texturizers, encapsulating agents…). Nexira's portfolio for supplement industry includes premium nutraceuticals, strongly supported with scientific & marketing supports, for digestive health, weight management, sports nutrition, joint health and men & women’s health.

Persephone is pioneering the use of synthetic biology for microbial products that impact patient and infant health. We are building an end-to-end platform to industrialize the development of engineered cells that restore health to damaged human ecosystems. The company was founded in the summer of 2017 by synthetic and metabolic engineering pioneers, Stephanie Culler PhD, and Steve Van Dien PhD.

Probi® is a global company focused exclusively on researching, manufacturing, and delivering probiotics for supplements and functional food. We are experts at managing stable, live bacteria from R&D through every stage of the manufacturing process, and are dedicated to making the health-enhancing benefits of probiotics available to people everywhere. Our health concepts, formulations, and formats are supported by robust clinical documentation. Since our founding in 1991 at Sweden's Lund University, Probi has expanded its operations to more than 40 markets. We hold more than 400 patents globally.

Probiotical is an Italian family-owned company specialized since 1985 in probiotics manufacture, from the raw material to the finished products, with very high quality, guaranteed stability and scientifically backed strains. We are driving innovation in a variety of functionalities and technologies. We offer our customers wide opportunities of customization and range extensions for probiotic blends and finished products ready-to-market, either under Probiotical's brand or in private label.

Protara Therapeutics, Inc., a clinical-stage company, engages in the identifying and advancing transformative therapies for people with rare and specialty diseases. The company's lead program is TARA-002, an investigational cell therapy for the treatment of lymphatic malformations. It also develops intravenous choline chloride, an investigational phospholipid substrate replacement therapy for the treatment of intestinal failure associated liver disease. The company was formerly known as ArTara Therapeutics, Inc. and changed its name to Protara Therapeutics, Inc. in May 2020. Protara Therapeutics, Inc. is based in New York, New York.

science backed probiotics, prebiotics & bioactive botanicals for targeted restoration res makes physician developed & physician recommended supplements creator of the world's first respiratory probiotic resB!

SFA Therapeutics is a clinical stage start-up biotech company developing compounds discovered in human microbiome. This patented and proprietary platform is based on immuno-modulation of inflammatory factors derived from human gut microbiome. The technology is licensed from and supported by research at Temple University in Philadelphia. These products are a unique native immunotherapy platform with activity currently being investigated in cancer, liver, and auto-immune disease.

Solarea Bio is a clinical-stage biotechnology company in Cambridge, MA developing plant-based microbial solutions to some of the world's largest health problems. Solarea was founded in 2017 by a group of scientists and entrepreneurs eager to radically alter our understanding of the human microbiome and utilize its power to improve human health. The Solarea breakthrough came from the combined efforts of the company's co-founders who established a link between the discovery of an untapped source of microorganisms with probiotic potential in healthy foods, and their applications in inflammatory processes including the gut-musculoskeletal axis. Using powerful genomic and bioinformatic tools, Solarea is mining its novel microbial strain collection to identify synergistic combinations of microbes and prebiotic plant fibers to develop solutions for patients suffering from inflammatory processes.

The trillions of microbes that call us home –the human microbiome – perform critical functions that preserve our health including helping develop our immune system, manufacturing nutrients such as vitamins, and harvesting energy from the diet. Alterations of the human microbiome are increasingly recognized as a key factor in autoimmune, metabolic, infectious and many other diseases. For millions of years, humans have co-evolved with this community of microbes, communicating in an ancient language that holds critical clues about how autoimmune and infectious diseases develop. This language is based on a system of signals that our resident microbes use to successfully colonize us, such as byproducts of bacterial metabolism and factors that bacteria use to adapt to human niches. Recent discoveries have shown that most of these signals do not lead to disease, rather, they promote our long-term survival. Vedanta is developing a novel class of therapies that modulate pathways of interaction between the human microbiome and the host immune system. Vedanta was co-founded by PureTech Health and a group of world renowned experts in immunology and microbiology

From discovery to scale, Verb Biotics applies science, technology, and intentional development to deliver microbiome health solutions. Verb Biotics is a business-to-business ingredient supplier of pro, post, and synbiotics for food, beverage, and dietary supplement brands.

Viomeanalyzes your microbiome and uses artificial intelligence to process the results and provide dietary advice.

Winclove Probiotics, quality of life with probiotics Since 1987, Winclove Probiotics has specialized in the development and production of probiotics. We work with passionate business partners, leading universities, various research institutes and university hospitals around the world to develop effective indication-specific probiotics. Aiming for long-lasting, sustainable and strategic partnerships, we not only offer innovative, high-quality and competitive probiotic solutions but also share our scientific knowledge as much as possible. At Winclove Probiotics, commitment, drive and optimism are important. Our Great Place to Work certification also shows that we have a company culture of humanity, diversity and trust. Since 2020, we have been part of the B Corp community, joining forces with like-minded companies to protect our planet and contribute to a sustainable economy. Together, we are using ‘business as a force for good'. -- Winclove Probiotics, kwaliteit van leven met probiotica Sinds 1987 is Winclove Probiotics gespecialiseerd in de ontwikkeling en productie van probiotica. Wij werken met gedreven businesspartners, vooraanstaande universiteiten, uiteenlopende onderzoeksinstituten en (universitaire) ziekenhuizen wereldwijd om effectieve indicatiespecifieke probiotica te ontwikkelen. We streven naar langdurige, duurzame en strategische partnerships waarbij wij niet uitsluitend innovatieve, hoogwaardige en concurrerende probiotica-oplossingen bieden, maar ook zoveel mogelijk onze wetenschappelijke kennis delen. Bij Winclove Probiotics zijn betrokkenheid, gedrevenheid en optimisme belangrijk. Ons Great Place to Work-certificaat toont tevens aan dat we een bedrijfscultuur van menselijkheid, diversiteit en vertrouwen hebben. Sinds 2020 zijn we onderdeel van de B Corp-community en bundelen we met gelijkgestemde bedrijven de krachten om onze planeet te beschermen en bij te dragen aan een duurzame economie. Samen gebruiken we ‘business as a force for good.'

Yakult is the world's leading probiotic beverage created in Japan in 1935. It is produced by Yakult Honsha Co., Ltd - the world's pioneer in probiotics. Today, Yakult is sold in more than 30 countries and regions around the world. Our company's portfolio includes a range of consumer, cosmetic and pharmaceutical products. For additional company information, please visit www.yakult.co.jp/english/. Science and research are the basis of our business. We have institutes in both Japan and Europe that are committed to discovering the endless applications for probiotics as well as the use of intestinal bacteria in human health globally. For more information about our science institutes, please visit www.yakult.co.jp/institute. Bringing Yakult to America is just one more step towards fulfilling Yakult's mission: to contribute to the health and happiness of every person around the world through the pursuit of excellence in life sciences and the study of microorganisms. We hope to achieve this goal while providing education to people about healthier living, developing community programs where we do business, and collaborating with medical doctors, dietitians and researchers. Yakult U.S.A. Inc. is a subsidiary of Yakult Honsha Co., Ltd. and is headquartered in Fountain Valley, CA. It supports Yakult's business in the United States and Canada. To contact our offices please email yakult@yakultusa.com.