Innovation Pharmaceuticals Plans for Clinical Trial of Oral Brilacidin for Ulcerative Colitis Program in 4th Quarter 2019

BEVERLY, MA – September 10, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that the Company is planning for the first human trial utilizing an oral formulation of Brilacidin in the program for Ulcerative Colitis (UC), a common type of Inflammatory Bowel Disease (IBD), in December 2019. Brilacidin is the lead drug candidate in the Company’s portfolio of novel compounds called defensin-mimetics, which are modeled on the body’s host defense response and exhibit immunomodulatory, anti-inflammatory and anti-infective properties.

The Company is working closely with BDD Pharma to utilize their patented OralogiK™ tablet technology, enabling targeted delivery of Briladicin to the colon. The first planned clinical trial of oral Brilacidin in the UC program will be in healthy volunteers in the United Kingdom. We are now engaged in having our vendor prepare Brilacidin for shipment to BDD where it will be manufactured into tablets for the trial. Final feedback and approval from the governing regulatory agency will be required to commence the study. The trial is designed to assess safety, toleration, pharmacokinetics, and whether the drug is being dispersed directly in the colon.

With the continued development of Brilacidin in IBD, the Company is building upon its successfully completed Phase 2 Proof-of-Concept trial of locally-administered Brilacidin, as a retention enema, for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS). The compelling clinical data from the UP/UPS study demonstrated the robustness of Brilacidin to induce clinical remission in this indication, and resulted a licensing deal signed with Alfasigma S.p.A., a global pharmaceutical company based in Italy. Per the agreement, the Company received an upfront cash payment and will receive future milestone and royalty payments upon reaching program milestones and with commercialization.

“Initiating the upcoming trial of oral Brilacidin in the Ulcerative Colitis program is an extremely important next step. Companies in the IBD space that can deliver oral drug candidates with targeted delivery to the gut can attract significant investment and partnering interest,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “While executing the Alfasigma deal in UP/UPS was a key milestone for the Company, Brilacidin’s potential in UC and Crohn’s Disease is considerably larger. If oral Brilacidin performs in UC like we believe it can, we should find ourselves in a strong negotiating position toward securing additional licensing agreements in a market that runs into the tens of billions of dollars.”

“With pharmaceutical industry interest in defensin-based therapies intensifying, as we’ve been witnessing firsthand across recent partnering interactions, the planned upcoming UC program trial couldn’t be happening at a better time—an opportunity to further develop Brilacidin’s platform potential,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “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. 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.”

The Company would also like to remind shareholders of the upcoming shareholder meeting on September 19.