Intrinsic Medicine, Inc. (Intrinsic), a therapeutics company leveraging human milk biology to transform Gut-Brain Axis (GBA) and inflammatory disorders, and Phoenix Biotech Acquisition Corp. a special purpose acquisition company formed for the purpose of acquiring or merging with one or more businesses, announced they have entered into a definitive business combination agreement. Upon closing of the transaction, anticipated to occur in the first half of 2023, the combined company will be named Intrinsic Medicine, Inc. and will be led by Intrinsic’s founding executives, Alexander Martinez, its CEO, and Jason Ferrone, its President and COO, each of whom will continue in their roles and serve on the combined company’s board. The combined company’s common stock is expected to be listed on the Nasdaq Capital Market under the ticker symbol “INRX”.
“This milestone marks an important moment for Intrinsic. With this commitment from PBAX, we will challenge the status quo to deliver a differentiated class of microbiome and immune-modulating medicines with the potential to provide true relief to individuals suffering from GBA disorders,” said Alexander Martinez, CEO of Intrinsic. “Today, we are seeing patients and physicians speak out about the need for better GBA treatments and we believe Intrinsic is developing the right medicines, for the right indications, at the right time. We are thrilled to be selected by the management and board of PBAX, whose members include veteran life-science venture capitalists, and are eager to take this next step with them.”
“After evaluating nearly 100 biotech companies, Intrinsic emerged as the standout choice for our business combination,” stated Chris Ehrlich, CEO and director of PBAX. “Intrinsic has the opportunity to demonstrate the potential benefits of its platform for patients living with GBA disorders with the near-term initiation of their Phase 2b clinical trial for IBS-C. We are confident that the highly experienced management team, with proven abilities to rapidly advance their unique pipeline of potentially transformative HMO-based medicines and accomplish important business initiatives with capital efficiency, are prepared to lead Intrinsic as a public company.”
“Our planned placebo-controlled Phase 2b clinical study of OM002 in IBS-C will be the first of its kind to evaluate the safety and efficacy of an HMO-based medicine in patients living with a GBA disorder,” said Jason Ferrone, President and COO of Intrinsic. “We anticipate disclosing top-line data from the study in the first half of 2024, which we expect will build on existing clinical, preclinical and toxicology data supporting the bioactivity, safety and tolerability of HMOs and validate the therapeutic use of these compounds,” Mr. Ferrone continued.
HMOs are the third most abundant solid component of human milk and have been shown to exert beneficial effects through multiple mechanisms of action, including by beneficially shifting the composition of the gut microbiome, increasing the microbiome’s production of beneficial metabolites, and directly modulating the immune system. Because HMOs have been selected and conserved over millions of years of mammalian evolution, with human beings exposed before birth and during early life development, HMO-based drugs have the potential for a favorable toxicity and tolerability profile in the therapeutic context, making them a potentially promising treatment option for expanded patient populations compared to drugs with significant side effects or toxicities.
Intrinsic’s pipeline consists of synthetic biology-produced HMO drug candidates based on some of the most abundant and well-characterized HMOs, including OM001 (3’sialyllactose, or 3’SL), OM002, and OM003 (6’-sialyllactose, or 6’SL), which it believes have the potential to treat GBA and certain inflammatory disorders, including irritable bowel syndrome (IBS), inflammatory bowel diseases, rheumatoid arthritis, oligoarticular juvenile idiopathic arthritis, atopic dermatitis, and autism spectrum disorder. Intrinsic selected these drug candidates based on its assessment of their probability of success in the clinic, considering published third-party clinical, preclinical and toxicology data indicating these HMO compounds have the potential for disease-modifying bioactivity combined with a low risk of dose-limiting toxicity. Intrinsic also considered commercial and practical factors such as market size, competitive landscape, and availability and scalability of clinical supply in the selection and prioritization of its drug candidates. Intrinsic’s drug candidates are protected by a patent portfolio consisting of a combination of issued and allowed patents and pending patent applications covering therapeutic and human health supporting methods of use that are owned or exclusively licensed to the company from third parties.
In particular, third-party published data on 2’FL, which reports both preclinical and exploratory clinical data in infants, healthy volunteers and IBS patients, supports Intrinsic’s therapeutic rationale for the clinical development of OM002 as a potential new medicine for the treatment of both IBS-C and the diarrhea predominant form of IBS (IBS-D). This includes a recent open-label study of a 2’FL-dominant HMO mixture in over 300 patients representing all subtypes of IBS that reported clinically significant improvements in IBS symptom scores of abdominal pain, bloating and stool consistency. As a result, Intrinsic believes OM002 has the potential to be the first drug, if approved, capable of treating both IBS-C and IBS-D, estimated to afflict over 10 million patients in the United States, alone.
The resources of the combined company are expected to provide Intrinsic with the capital to advance OM002, its lead compound, and additional pipeline assets into development with several near-term milestones, including the following:
- Initiate a Phase 2b clinical study under an approved protocol in Australia using FDA-recommended primary endpoints to test OM002 in over 400 patients with IBS-C, with topline data expected in the first half of 2024.
- Initiate and complete confirmatory chronic toxicology studies to support future pivotal trials for OM002.
- Support the advancement of OM001 into the clinic for its initial indication.