BEVERLY, MA – November 8, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide a corporate update highlighting business development and clinical pipeline priorities across its first-in-class drug candidates, Brilacidin, Prurisol and Kevetrin.
“A successful End-of-Phase 2 FDA meeting for our Brilacidin-Oral Mucositis asset, or positive results from our Phase 2b Prurisol trial in psoriasis—either outcome we believe would open up enormous possibilities for our shareholders,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “We look forward to updating shareholders on these, and other company developments, as we continue to lay a strong scientific foundation upon which future successes can be built.”
Corporate priorities, and upcoming events, include:
· Convening the End-of-Phase 2 meeting with the Food and Drug Administration (FDA) to discuss the expedited development of Brilacidin-Oral Mucositis. The meeting, scheduled for later this quarter, helps align with the FDA on clinical trial design and other program requirements.
· Analyzing Prurisol topline results in Psoriasis once full payment can be made to the Contract Research Organization (CRO) based on amounts owed, which were, in part, more than budgeted due to significant cost overruns. A partial payment was recently made, with additional payments planned.
· Selecting a CRO to complete the necessary remaining bridging toxicology work, approximately half of which has been completed, toward developing Kevetrin (our p53-modulating anti-cancer drug) in oral formulation and commencing its next clinical trial. As Kevetrin is not cytotoxic, the possibility exists for an oral version of Kevetrin to commence a Phase 1/1b study in healthy subjects, followed by a Phase 2 study—shortening the development timeline significantly.
· Continuing to advance partnership discussions, with our primary objective to complete licensing deals that provide access to non-dilutive capital to move our clinical assets forward in the most expeditious and cost-effective manner.
· Manufacturing Brilacidin final drug substance/drug product for a future, and potentially pivotal, Oral Mucositis clinical trial and, more broadly, for the bulk production of commercial-grade drug supply. The Company has already paid contracted vendors over $1 million toward project completion.
· Presenting a scientific poster on Brilacidin for Inflammatory Bowel Disease (IBD) at the “IBD Innovate 2018” conference sponsored in part by the Crohn’s & Colitis Foundation and held in New York City. The poster will be available in the Events and Presentations section of the Company website on November 13, 2018.
· Expanding the Company’s Intellectual Property when appropriate, as was recently completed in relation to Brilacidin—the U.S. Patent & Trademark Office announcing allowances directed to oral, buccal, and sublingual pharmaceutical compositions of the drug.
· Developing an oral formulation of Brilacidin to treat more extensive forms of IBD (e.g., Ulcerative Colitis and Crohn’s Disease) and a topical formulation of Brilacidin for Inflammation and Immunology (I&I) conditions (e.g., Atopic Dermatitis and Acne), in preparation for subsequent clinical trials.