Innovation Pharmaceuticals now has a global licensing agreement with Alfasigma for the development and commercialization of the therapy Brilacidin for treating ulcerative proctitis/ulcerative proctosigmoiditis (UP/UPS), types of inflammatory bowel disease (IBD).
Innovation’s lead candidate, Brilacidin is a synthetic small molecule that structurally resembles some of the proteins the body produces to fend off bacteria and other microbial invaders. That’s why it’s being studied as an antibiotic. But, Brilacidin also has immunomodulatory properties — meaning it can lower inflammation and even promote wound-healing — making it a prospective therapy for UP/UPS, a type of ulcerative colitis.
Data from a proof-of-concept clinical trial in UP/UPS, in which Brilacidin was administered via enema, showed the treatment’s safety and effectiveness. Half of the patients (six) treated with the compound went into clinical remission and two went into partial remission. Last November, Innovation presented a scientific poster at the inaugural IBD Innovate 2018 conference, hosted by the Crohn’s & Colitis Foundation.
”This licensing agreement with Alfasigma is a major milestone for the company,” said a press release statement by Arthur P. Bertolino, MD, PhD, Innovation’s president and chief medical officer. “We are confident that Brilacidin for UP/UPS is in good hands, as Alfasigma works to potentially commercialize the drug. At the same time, we’re excited to be underway with our own Brilacidin oral formulation efforts to treat more extensive forms of IBD.”
Under terms of the pact, Innovation will receive more than $24 million in an initial sum and milestone-based payments, plus 6% of net sales. The agreement also calls for right of first refusal for Brilacidin for the treatment of other forms of IBD, such as ulcerative colitis and Crohn’s disease, and a right of first negotiation for the therapy in other gastrointestinal conditions.
Last month, Innovation signed an agreement to use OralogiK — an advanced tablet-coating technology patented by BDD Pharma — to develop tablets for targeted oral delivery of the treatment in the colon of IBD patients. The company is expecting to start in-human testing as early as year’s end, the release said. Other formulation plans include foam and/or gel for mild-to-moderate UP/UPS.
”The Phase 2 Brilacidin clinical study results in UP/UPS look promising and reflective of Brilacidin’s unique drug properties and treatment potential,” said Pier Vincenzo Colli, CEO of Alfasigma. “Alfasigma plans to dedicate considerable internal resources, including formulation and IP (Internet Protocol) expertise, and to make a substantial investment to advance Brilacidin, with the objective to offer patients a safe and effective new treatment option in the management of UP/UPS.”
IBD affects 10 million individuals worldwide, including 3 million U.S. residents, said Innovation, a clinical-stage biopharmaceutical company. Alfasigma is a privately owned multinational pharmaceutical company based in Italy.