Immuron updates about drug candidate IMM-529; obtains new US patent from USPTO

  • Mar 19, 2019 AEDT
  • Team Kalkine
Immuron updates about drug candidate IMM-529; obtains new US patent from USPTO

Immuron Limited (ASX: IMC) is an Australian based biopharmaceutical company. It is engaged with marketing and selling of Travelan in Australia for the prevention of Travellers’ Diarrhea. IMC also markets it in the USA and Canada as a dietary supplement for digestive tract protection. The orally delivered targeted polyclonal antibodies are currently in the process of development and commercialisation phase in the company, which would help treating inflammatory mediated and infectious diseases.

On 19th March 2019, the company announced that it had been issued a patent by the United States Patent and Trademark Office (USPTO) for a method to treat Clostridium difficile infections. The patent (USPTO No. 10144775) is entitled “Methods and compositions for the treatment and/or prophylaxis of Clostridium difficile associated disease”. This patent has been secured to provide drug composition while treating Clostridium difficile infections. The targeted drug composition comprises of an enriched, hyperimmune polyclonal antibody preparation of bovine colostrum, for being used in treating C. difficile, a bacterium that causes life-threatening diarrhea. This technology is used by drug candidate IMM-529 which is currently in a Phase 1/2a clinical trial in C. difficile patients.

  1. difficile Infection (CDI) is a serious medical problem, which causes an annual economic burden of an estimated US$10 billion across the world. C. difficile Infection is especially acute in hospitals, and long-term in-patient care facilities. On top of that, it is compounded by a high rate of recurrence in patients treated with front-line antibiotics.

The company’s drug candidate IMM-529 is not an antibiotic. It contains hyperimmune polyclonal antibody colostrum agent, that can bind and inactivate not only the C. difficile toxin B, but also spore antigens and vegetative cell antigens. The company is focusing on developing IMM-529 to treat patients with recurrent C. difficile with the filing of an investigational new drug (IND) with the Food and Drug Administration (FDA). This will enable the company to include clinical sites in the U.S. as well as in the rest of the world.

The company’s phase I/IIa clinical trial of IMM-529 in patients with C. difficile is presently being conducted in two clinics in Israel, but it has not met the patient enrolment numbers which the Company anticipated. As a result, the current enrolment protocol has been changed by the company in order to address this issue. The Company has completed feasibility and Australian-site identification process, after which it expects to have Australian clinical sites open for recruitment of patients shortly. The drug candidate IMM-529 would be further developed after the company’s IND filing with the FDA. The Company’s strategic plan to specifically focus on treating patients, with the recurrent disease would help the company to pursue and meet the medical need in the treatment of patients suffering from C. difficile infections.

On 29th January 2019, the company announced Travelan’s entrance in the Canadian market and on 3rd January 2019, the company received R&D tax concession refund of $1.19 million.

On the technical front, the stock of the company increased by 2.174% on ASX. By the end of the trading session, it closed at A$0.235 as on 19th March 2019, compared to the previous closing of A$0.230. In the last six months, the stock had fallen by 31.34% while YTD return stands positive at 9.52%.


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