Intrinsic Drug Stock: Leveraging Identical Human Milk Oligosaccharides (INRX)

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Intrinsic Medicine, Inc. (INRX) is a developer of preclinical-stage synthetic biology therapeutics. The companyThe product candidates of are based on human milk oligosaccharides (‘HMO) which can modulate the intestinal microbiota as well as human cells and the immune system. Comprising over 200 oligosaccharides, the third most abundant solid component of breast milk, HMOs have structural diversity with distinct bioactivity that can be used – according to this preclinical company – to develop new targeted drugs to treat a gut-brain axis specific (‘GBA’ troubles.

The companyScientists at have developed a process for making these molecules that are identical to those found in human breast milk. Oligosaccharide identical to synthesized human milk (“HiMO) molecules have been shown to be effective in treating various diseases, including gastrointestinal disorders, respiratory infections and cancer. The potential benefits of using HiMOs as treatments are significant. They can be administered orally or intravenously and, unlike traditional medications, are not prone to side effects. WhatAlso, because they are derived from human breast milk, they are unlikely to elicit an immune response in patients. This could make it an ideal treatment option for patients who have failed other therapies or cannot tolerate traditional medications.

The therapeutic potential of HiMOs lies in their ability to modulate the gut microbiome, which has been linked to a wide range of diseases. The first indication that the Company is targeting is inflammatory bowel disease (‘IBD), a group of chronic diseases that affect the digestive system. Patients with IBD have an altered gut microbiota that contributes to gut inflammation. By administering the HiMOs orally, the Company hopes to restore balance and reduce inflammation in these patients.

There is also proof that HiMOs may benefit other disorders associated with gut dysbiosis, such as obesity and type 2 diabetes. A study showed that obese mice treated with a HiMO-based supplement lost more weight and had lower blood sugar levels than control mice fed a standard diet. These results suggest that HiMO-based therapies could also be used as novel treatments for obesity and type 2 diabetes in humans. The companyThe approach has several advantages over existing treatments for IBD, and possibly obesity and type 2 diabetes:

  • HiMO molecules are manufactured by synthetic biology, which allows precise control of their composition;

  • They are derived from human milk oligosaccharides (HMOs), which are natural ingredients shown to be safe and effective in clinical studies;

  • Unlike other drugs used to treat these diseases, HiMO molecules do not alter the gut microbiota indiscriminately; instead, they selectively target disease-causing bacteria while leaving healthy bacteria untouched.

HiMOs have already been shown to be effective against a number of diseases. In particular, they have been shown to be effective against both rotavirus and norovirus, two major causes of diarrhea in children. Additionally, HiMOs may also prove useful in the treatment of other conditions such as cancer and autoimmune diseases.

Pipeline and trials

The company believes “HiMO drugs may have a favorable toxicity and tolerability profile in the therapeutic setting,” because “HMOs have been selected and conserved over millions of years of mammalian evolution, with all humans being exposed before birth and during early life development.“The company has only recently produced individual HMO-equivalent oligosaccharide drugs (‘OMs) on a scale sufficient for therapeutic development and potential commercialization. The Company has “selected these drug candidates based on clinical, preclinical and toxicology data published by third parties indicating the potential for bioactivity of disease-modifying HMOs combined with a low risk dose-limiting toxicity.

Pipeline

Pipeline (Company Website)

The companythe lead drug candidate of is OM002 (2‘FL or fucosyllactose) which will be evaluated for the treatment of constipation-predominant irritable bowel syndrome (‘IBS-C), in the CompanyThe first phase 2 clinical trial of will be launched in 1H-2023 in Australia. Additionally, based on comments received from the US FDA during a pre-IND interaction, the Company will conduct its own confirmatory toxicology studies for data to be included in its scheduled 1H-2023 IND application to initiate the phase 2 trial in the United States. OM002 will also be evaluated for the treatment of diarrhea-predominant IBS (‘IBS-D). If approved, OM002 could potentially be the first drug to treat both IBS-C and IBS-D, which are estimated to affect more than 10 million people in the United States and about 1 person in 10 in the world.

OM001 (3‘SL or sialyllactose) is advanced in rheumatoid arthritis and juvenile idiopathic arthritis for which an IND/CTA must be submitted for the initiation of a phase 1b trial. A pre-IND interaction with the FDA is planned to support pilot trials in atopic dermatitis and autism spectrum disorders (‘ASD).

OM003 (6‘SL) is advanced for ASD and pain. Preclinical research must be completed prior to pre-IND interaction with supportive FDA pilot trials.

Management

The companyThe leadership team includes – Co-Founder, President and CEO Alexander Martinez, who has over 16 years of healthcare experience, most of which with Ionis Pharmaceuticals, Inc. and Akcea Therapeutics, Inc. .; co-founder, president and chief operating officer Jason Ferrone, who has worked in drug discovery and development for more than 20 years, half of which at Ionis as a clinical manager as well as a regulatory affairs manager; CMO Emil Chuang, MB, BS (SYD) FRACP, is a pediatric gastroenterologist, with academics from the University of Sydney, and an initial career at Duke University and the University of Pennsylvania. Dr. Chuang has over 20 years of industry experience including Centocor Biotech, Inc. (now known as Janssen Biotech, Inc.), Nestle Health Science SA, Takeda Pharmaceutical Company, Ltd. and Progenity, Inc.

finance

The company was originally incorporated as Lupa Bio, Inc. in August 2018 and later changed its name to Intrinsic Medicine, Inc. in August 2020. A wholly owned subsidiary, Intrinsic Medicine AU Pty LTD, was established in October 2021. The company has accumulated a deficit of approximately $14.3 million as of 12/31/2021, and its cash balance of $2.77 million is not sufficient to operate the business during of the next 12 months. The Company has filed a Form S-1 declaration of registration for an initial public offer (‘IPO) of an undetermined number of common shares which are not yet priced, and has applied to list its common shares on the Nasdaq Capital Market under the symbol INRX. The record also includes shares for sale by certain selling shareholders.

Risks

Intrinsic medicine is a “emerging growing company” and one “unaccelerated file” and one “small reporting company“under which the Company may benefit from exemptions from reporting obligations.

The Company has a limited operating history and is at a very early stage of development. It will be several years before they complete clinical trials and reach the regulatory stage.

The Company has incurred losses since its inception, accumulating a deficit of approximately $14.3 million as of 12/31/2021. The company does not have a cash trail for 12 months and unless funding is reached with the IPO or otherwise, the company may not be able to continue in business.

There is significant competition not only from larger and better funded private and public healthcare companies, but also from non-prescription products marketed as dietary supplements.

The companyOM’s drug candidates are intended to be a prescription-only form of naturally occurring HMOs. Therefore, intellectual property protection may be limited to the method of use, leaving the market wide open to competitors. In addition, the Company is heavily dependent on Glycosyn as the licensor of its lead drug candidates, the rights to which Glycosyn itself has acquired through an exclusive, sub-licensable, worldwide license from the patent holders, Cincinnati Children‘s Hospital Medical Center and other licensors hereunder, or Glycosyn In-License, and to enable manufacturing technology related to the synthesis of OM drug candidates. The Company is also heavily dependent on The Regents of the University of California, through its San Diego campus, The University of California San Diego, or UC San Diego, as the licensor of certain of its lead drug candidates.

The Company is entirely dependent on third-party suppliers for clinical and commercial supplies, including active ingredients that are used in its drug candidates. It also relies on a single supplier, Royal FrieslandCampina NV, a Dutch multinational dairy cooperative based in Amersfoort, the Netherlands, and its subsidiaries, for some of its supplies, and intends to continue to rely on this one.

Conclusion

Harnessing synthetic biology-made HiMO molecules as new drugs could revolutionize the way we treat various diseases. If further research and trials confirm their effectiveness against other diseases, this could lead to an entirely new class of drugs that is safer and more effective than currently available treatments. Intrinsic medicine is currently at an early stage with its HiMO molecule therapy and the next few years are very crucial for them. While targeting the human gut microbiome is exciting, we have no investment interest in this early stage venture at this time.

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