Innovation Pharma Planning 1st Clinical Trial of Oral Brilacidin as Potential Ulcerative Colitis Treatment

Innovation Pharmaceuticals is planning a first clinical trial of an oral formulation of Brilacidin as a treatment for ulcerative colitis (UC), one of the most common types of inflammatory bowel disease (IBD).

Brilacidin is a synthetic small molecule that belongs to a new class of compounds known as defensin-mimetics. It is structurally similarity to proteins naturally produced in the body that fend off bacteria and other microbes.

Preclinical and clinical data have demonstrated that this compound holds strong immunomodulatory, anti-inflammatory, and anti-infective properties.

“With pharmaceutical industry interest in defensin-based therapies intensifying … the planned upcoming UC program trial couldn’t be happening at a better time — an opportunity to further develop Brilacidin’s platform potential,” Leo Ehrlich, CEO of Innovation, said in a press release.

“Defensins function in a broad immunomodulatory capacity, exhibiting beneficial characteristics, both anti-inflammatory and anti-infective. Defensin-based therapies thus have the unique potential to treat a wide array of diseases,” Ehrlich added. “Brilacidin is the only defensin-based drug candidate in later-stage clinical testing — now anchored by successful results in acute bacterial skin and skin structure infection, oral mucositis, and IBD — and is poised to be a potential game-changer in the field of promising therapeutics.”

Innovation is collaborating in this program with BDD Pharma, using the company’s proprietary OralogiK technology to develop tablets for targeted oral delivery of Brilacidin to the colon.

This first-in-human trial of oral Brilacidin, planned to open in December, will assess the therapy’s safety, tolerability, therapeutic activity, and chemical stability in a group of healthy volunteers in the U.K., according to Innovation. BDD will be responsible for manufacturing the tablets to be administered during the trial.

Innovation is now waiting for regulatory approvals to initiate the study. If given and results are positive, more advanced clinical studies in UC patients are anticipated to start in 2020.

The planned trial builds up on data generated by a Phase 2 proof-of-concept trial, showing that when administered locally through an enema (commonly known as clyster), Brilacidin led to clinical or partial remission in most patients with ulcerative proctitis/ulcerative proctosigmoiditis (UP/UPS), two milder forms of UC.

Recent preclinical studies showed that the newer oral dosage formulation of Brilacidin complies with the required chemical characteristics for selective delivery to the colon.

“We are delighted to have met the in vitro specifications for development of an oral Brilacidin product for targeted delivery to the colon and look forward to the upcoming clinical studies,” Howard Stevens, PhD, chairman of BDD Pharma, said in a separate press release.