Latest Results Further Support Topline Data Showing Trial Met Primary Endpoint of Reducing Incidence of SOM
BEVERLY, MA – January 3, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today presented additional secondary endpoint topline results from the Company's randomized, double-blind, placebo-controlled, Phase 2 clinical trial of Brilacidin (see NCT02324335) for the prevention and control of Oral Mucositis (OM) in patients receiving chemoradiation for treatment of Head and Neck Cancer.
Previously released results from the study showed the use of Brilacidin-OM met its primary endpoint with a clearly reduced incidence of severe OM (SOM) (WHO Grade ≥ 3) compared to placebo. Brilacidin-OM is being developed with global patent protections under an FDA Fast Track designation for this indication.
Summary of Key Secondary Endpoints Analysis
· Onset of Severe Oral Mucositis: Based on Kaplan-Meier curves, Brilacidin-OM oral rinse showed a clear separation from placebo in delaying the onset of SOM—particularly the period from approximately 28-42 days, after the initiation of treatment, during which the incidence of SOM rose strikingly in the placebo group while not in the group being treated with Brilacidin. The delay of onset of SOM data further support the positive primary endpoint findings that showed a clear reduction in the incidence of SOM in patients receiving Brilacidin-OM treatment. Our updated Corporate Overview, with a visual display of the Kaplan-Meier curves, is now available (pdf) on the Company’s website.
· Duration of Severe Oral Mucositis: Given that Brilacidin-OM successfully prevented SOM from occurring, as well as delayed its onset, in a substantial number of patients, data comparisons aimed at assessing potential reduction in the duration of SOM were constrained by the fewer number of Brilacidin-OM treated patients that could be included in such analysis. While Brilacidin-OM appeared to decrease the initial duration of SOM (time from the initial WHO Grade ≥ 3 to the first WHO Grade ≤ 2 OM assessment), detailed interpretation of this and other duration data comparisons were limited.
“The notable effect of Brilacidin-OM in delaying the onset of SOM in patients—on top of preventing it—further substantiates the drug candidate’s potential to emerge as a highly efficacious, safe and easy-to-administer preventative medicine for this notoriously painful and difficult-to-treat condition,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “That Brilacidin performed so well in this clinical trial puts us in an extremely advantageous position in both a competitive and regulatory sense. The unmet medical need in OM is tremendous and we look forward to advancing Brilacidin-OM toward possible market approval, which would help improve the lives of so many cancer patients.”
The Company is now working to complete the Clinical Study Report (CSR). The CSR is central for engaging with the FDA to further discuss program development, and is also an important component for informing already advanced OM partnership discussions. In Brilacidin-OM, based on the strong positive Phase 2 clinical results, the Company believes it has a highly promising and unique late-stage OM drug candidate that, with approval, could assume the leadership position in a market with untapped economic potential. The global OM market is expected to exceed $1 billion in the next few years.
Biotech Showcase Details
The Company will be presenting at the 2018 Biotech Showcase Investor and Networking Conference, held January 8-10, in San Francisco, as detailed below:
Date: Monday, January 8, 2018
Time: 4:00 PM PST
Track: Yosemite - C (Ballroom Level)