BEVERLY, MA – April 9, 2019 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report that the Company has implemented yield and purity enhancements in the manufacturing of Brilacidin for the bulk production of Phase 3 drug supply using the Quality by Design approach. This and other efforts associated with the chemical processes aim to achieve drug supply optimization for commercial use.
The Company is now positioning itself to further advance Brilacidin, most immediately, in its planned Phase 3 Oral Mucositis program, and in mid-stage testing for Inflammatory Bowel Disease.
“Making these enhancements to Brilacidin is a crucial development step to ensure consistent, high-quality drug substance,” commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “The Company believes that its Brilacidin franchise will one day provide patients and providers with multiple, much-needed novel and effective medicines.”
In other news, the Company will commence Scientific Advice discussions with the European Medicines Agency (EMA) this week, via a scheduled meeting, to review plans for the international Phase 3 Brilacidin Oral Mucositis program. Also in the coming weeks, the Company plans to provide an update on its Brilacidin program for the treatment of Inflammatory Bowel Disease.
Brilacidin is Innovation Pharmaceuticals’ lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing. Due to its unique properties, the Company has studied Brilacidin’s effect on Oral Mucositis (under Fast Track designation) and on Ulcerative Proctitis/Proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: Atopic Dermatitis and Acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and a potential extra 5 years of United States market exclusivity upon drug approval.