Adiso ‘sprints out of the gate’ with inflammatory disease focused pipeline that includes LBPs

The clinical-stage biopharmaceutical company is backed by Morningside Ventures.

As well as looking to advance a pipeline of small molecules with novel mechanisms of action, Adiso is focused on the development of single strain live biotherapeutic products (SSLBP), pursuing lead indications in ulcerative colitis, and C. difficile infection (CDI).

“Critical unmet medical needs exist for new therapies that target the underlying biology of inflammatory diseases without causing systemic immunosuppression,”​ said Jason Dinges, Morningside technology advisory and Adiso board member. “Adiso is sprinting out of the gate with three very promising clinical programs for the treatment of ulcerative colitis and the prevention of recurrent CDI.”​

Scott Megaffin has been named as the biopharma company’s CEO. Adiso flagged his 30+ years of industry experience and a successful track record in senior leadership roles at Bristol-Myers Squibb, and Pfizer, among others. Most recently, he was CEO of Adastra Pharmaceuticals, an oncology clinical-stage development company. 

“At Adiso we are tackling inflammatory diseases with diverse mechanisms and a bold approach. We envision a new reality for patients, leveraging known advances of inflammatory therapeutics which promise to recalibrate the immune system of the host, so that the underlying inflammatory disease is neither overactivated nor does the patient becoming immunocompromised,”​ said the CEO.

The company’s lead clinical candidates include ADS024: an oral single strain live biotherapeutic product (SS-LBP) aimed at tackling 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.

Collaborative research 

Those development programs follow on from work Adiso carried out with institutional and academic collaboration, including with University College Cork in 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.

ADS024, said the biopharma firm, is designed to modulate inflammation as a single strain multimodal LBP and is manufactured from a clonal bacterial cell bank, yielding a standardized lyophilized drug product, which it explained eliminates 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.”​

Microbiome space ​

Competition is intensifying in the microbiome space, with a number of players now active in the inflammatory disease treatment arena.

Last week saw UK-based Microbiotica raise €60M (US$65.7m) in a Series B round to advance two LBP candidates, which are focused on the treatment of ulcerative colitis and cancer. 

Microbiotica’s financing round was co-led by Sweden’s Flerie Invest and China-based Tencent, and was supported by existing investors including the French investment firm Seventure Partners.

The proceeds of the fundraising effort will be used to progress the company's two lead candidates - MB097 and MB310 - to Phase 1b clinical studies. MB097 is aimed at boosting patient response to immune checkpoint inhibitor therapy. MB310 is geared towards the treatment of ulcerative colitis.

Meanwhile, US company, Seres Therapeutics, is continuing to prepare its BLA filing submission for its oral microbiome therapeutic, SER-109 with the US Food and Drug Administration (FDA) for recurrent C. difficile​ infection. Clinical trial data - the company's Phase 3 ECOSPOR III study - showed that investigational LBP beat a placebo in treating C. diff​ infection.