Nears Selecting Drug Formulation Company to Prepare Oral Brilacidin for Targeted Delivery in Ulcerative Colitis
BEVERLY, MA – May 21, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that the Company attended the annual Digestive Disease Week® (DDW) Conference held at the San Diego Convention Center in San Diego, California from May 18-21, 2019.
DDW is the world's leading educational forum for academicians, clinicians, researchers, students and trainees working in gastroenterology, hepatology, GI endoscopy, gastrointestinal surgery and related fields. Innovation Pharmaceuticals held constructive meetings covering the next stages of the Company’s pipeline development, aiming for advancement of Brilacidin in Inflammatory Bowel Disease (IBD), including Ulcerative Colitis (UC) and Crohn’s Disease (CD).
As the Company works towards finalizing a definitive agreement with respect to Brilacidin for Ulcerative Proctitis (UP)/Ulcerative Proctosigmoiditis (UPS), management is aligning to address additional IBD markets where it believes there are large market opportunities for Brilacidin to potentially become a leading therapeutic. The Company is currently in discussions with several vendors regarding innovative advanced technologies for targeted oral delivery of Brilacidin to the colon, with expectations that a drug formulation company may be contracted in the coming weeks to begin this work.
“Careful selection of an appropriate drug formulation partner should prove invaluable in expeditiously moving Brilacidin forward for diseases like UC and CD, disorders that remain in need of safe and effective options for millions of patients,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “There is only one new oral medication available today for moderate-to-severe UC, a JAK inhibitor approved last year that recently was the subject of an FDA warning about potentially severe side effects, a treatment disadvantage that is also common to biologic-based IBD therapies. Our aim is to develop a safe competitor with a novel mechanism of action in an oral formulation of Brilacidin with the anticipation that it may achieve similar results to the retention enema version that proved effective in our Phase 2 proof-of-concept study of Brilacidin for UP/UPS. A majority of patients tested achieved clinical remission, as supported by evidence of mucosal healing via endoscopic review. Development of an appropriate oral formulation of Brilacidin will position us to move into clinical testing soon thereafter.”
About Brilacidin for IBD
Inflammatory Bowel Disease (IBD) is a hard-to-treat, chronic, autoimmune condition that affects approximately 10 million people worldwide, including 3 million people in the U.S., with 70,000 newly diagnosed cases each year. The overall GI market sector is estimated to grow from $35.7 billion in 2015 to $48.4 billion by 2022. Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment, with formulation plans including oral tablets for Ulcerative Colitis and Crohn’s Disease, and foam and/or gel for mild-to-moderate Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of IBD. As released previously, a majority of patients treated with Brilacidin administered via retention enema achieved Clinical Remission (Modified Mayo scoring) in a Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for UP/UPS. In addition, mucosal healing was evidenced by endoscopic review, an increasingly important measure toward establishing a drug’s efficacy. In late 2018, the Company presented a scientific poster—Brilacidin for Inflammatory Bowel Disease (available for download here, pdf)—at the inaugural “IBD Innovate 2018” conference, hosted by the Crohn’s & Colitis Foundation. Brilacidin may be particularly beneficial in treating IBD due to: 1) its ability to inhibit Phosphodiesterase 4 (PDE4), which is being pursued as a novel therapeutic avenue in IBD; and 2) its potential to compensate for defensin deficiencies that are implicated in the pathogenesis of IBD.