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KUALA LUMPUR, Recursion, a clinical stage TechBio company, announced the first patient has been dosed in its Phase 2 clinical trial of REC-3964, a potential first-in-class, oral small molecule and new chemical entity for the treatment of recurrent Clostridioides difficile (C. diff) infection.
‘There is a significant unmet need for new treatment options for patients with C. diff infections that are easier to use and more cost-effective. We are encouraged by the progress of REC-3964, the first new chemical entity from our platform to advance to Phase 2 clinical trials, and now to the first patient dosed.
‘We look forward to continuing to advance this trial to help patients in need and drive down billions in costs to the healthcare system for treatment,’ said Recursion co-founder and chief executive officer, Chris Gibson in a statement.
The Phase 2 ALDER clinical trial is a multicentre randomised study to investigate the safety, tolerability, pharmacokinetics (PK) and efficacy of REC-3964 at doses of 250 mill
igramme (mg) or 500 mg for the reduction of C. diff and will include an observation only arm. Approximately 80 individuals will ultimately be enrolled in the study across the U.S. and Europe.
The C. diff infection is a toxin producing bacteria that causes diarrhoea and colitis, and can be life threatening, affecting up to 730,000 people annually in the United States (US) and EU5 countries (France, Germany, Italy, Spain, and the United Kingdom), causing an estimated 29,000 deaths in the US each year.
Recursion’s study will initially address the recurrent C. diff (up to 175,000 cases in the US per year) population, which costs the healthcare system approximately US$2 billion per year. (US$1=RM4.32)
Antibiotics, the standard treatment for C. diff infection, disturb the gut microbiome due to their non-selective nature. Despite initial success, antibiotics fail to prevent recurrence in 20 to 30 per cent of primary cases.
REC-3964 is the first novel small molecule developed through Recursion’s Operating System,
and selectively inhibits the glucosyltransferase activity of toxin B produced by C. diff in the gastrointestinal tract, offering a unique mechanism of action.
Unlike antibiotics, which disrupt the gut microbiome, REC-3964 precisely targets the bacterial toxin while sparing healthy tissue, potentially minimising adverse events and it is being studied as part of a treatment regimen to prevent recurrent C. diff infection.
Presented at the sixth edition of the World Congress on Infectious Diseases, preclinical studies demonstrated its superiority over bezlotoxumab in a human disease-relevant C. diff hamster model.
Additionally, Phase 1 studies in healthy volunteers showed REC-3964 was well tolerated with no serious adverse events (SAEs), underscoring its potential safety and tolerability.
Source: BERNAMA News Agency
