Adiso Therapeutics, Inc., a clinical-stage biotechnology company committed to creating medicines that treat inflammatory diseases and improve the lives of patients and their families, today announced the completion of patient enrollment in the Phase 1b clinical study evaluating ADS024, an orally delivered single strain live biotherapeutic product (SS-LBP), for the prevention of C. difficile infection (CDI) recurrence.
This Phase 1b study is a randomized, placebo-controlled, double-blind, multi-site study in which 36 subjects have been enrolled in two cohorts (A & B). Each patient had a recent CDI and had completed a standard of care course of antibiotics.
These patients had been determined to have achieved clinical cure based on signs and symptoms. They were then randomized to 7 or 28 single daily doses of ADS024 or placebo (NCT04891965).
Half of the enrolled subjects had experienced their first CDI while the other half had experienced >1 CDI recurrences. Primary endpoints are safety and tolerability.
ADS024 clinical activity will be determined by the prevention of CDI recurrence through week 12 (cohort A) or week 16 (cohort B). Topline data are expected in the third quarter of 2022.
“In CDI, current standard of care antibiotics can disrupt gut microbiota, resulting in the recurrence of C. difficile infection. The subsequent toxin-mediated damage can lead to impaired quality of life for the patient and significant healthcare costs,” said Scott Megaffin, Chief Executive Officer, Adiso Therapeutics. “The burden of treating CDI recurrence is significant and there’s a tremendous opportunity for new modalities, like ADS024 which in preclinical studies has demonstrated an ability to kill C. difficile and degrade its toxins. The potential clinical application of a live biotherapeutic that is not dependent upon the need for engraftment, nor the requirement for fecal matter transplant, and that allows the patient’s normal microbiota to recover represents a breakthrough.”
ADS024 is an oral single strain live biotherapeutic product (SS-LBP) for the treatment of mild-to-moderate ulcerative colitis and for prevention of C. difficile recurrence. A naturally occurring live biotherapeutic product, ADS024 modulates inflammation as a single strain multimodal LBP and is manufactured from a pure, clonal bacterial cell bank, yielding a standardized lyophilized drug product eliminating the need to directly source from donor fecal material. Clinical application of therapeutic bacteria represents a new approach in the future treatment for a range of human diseases. ADS024 is being evaluated in a Phase 2 study in mild-to-moderate ulcerative colitis and in a Phase 1b study for C. difficile recurrence. It has been granted Fast Track Designation by the FDA for the treatment of patients with C. difficile infection.
About C. difficile
Clostridium difficile is a gram positive bacterium that causes a severe form of diarrhea and colitis. Individuals at highest risk for C. difficile infection (CDI), a serious disease of high unmet need, are those of advanced age who have had recent antibiotic exposure, proton pump inhibitor use, a long stay in a hospital setting, a serious underlying illness, or are immunocompromised. According to the Centers for Disease Control and Prevention (CDC), C. difficile leads to almost half a million infections in the U.S. each year; and approximately 1 in 6 individuals experience a recurrent episode within 2-8 weeks. In 2014, CDI caused over 44,500 deaths. The estimated economic cost of CDI is $5.4 billion.
About Adiso Therapeutics:
Adiso Therapeutics is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients and their families by creating new medicines to treat inflammatory diseases. This dedication is epitomized by our lead clinical candidates, ADS024, an oral single strain live biotherapeutic product (SS-LBP) for the treatment of mild-to-moderate ulcerative colitis and prevention of C. difficile recurrence; ADS051, an oral, gut-restricted modulator of neutrophil trafficking and activation for the treatment of moderate-to-severe ulcerative colitis; and ADS032, a dual NLRP3/NLRP1 inflammasome inhibitor initially being developed for inflammatory diseases of the lung. Adiso has built these development programs upon a rich history of institutional and academic collaboration, including the University College Cork, Ireland, the APC Microbiome Institute, the University of Massachusetts Chan Medical School, the Hudson Institute of Medical Sciences Centre for Innate Immunity and Infectious Diseases in Australia and the University of Edinburgh Centre for Inflammation Research.