On January 16, 2018 Innovation Pharmaceuticals, (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported shareholders of a productive appearance by Innovation last week at leading health care meetings held in San Francisco, with an audio file of the Biotech Showcase presentation now available on the Company website (Press release, Innovation Pharmaceuticals, JAN 16, 2018, View Source [SID1234523142]).
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Interest in the Brilacidin Franchise—based on the breadth of its treatment potential—was notable. Strong momentum gained as a result of Brilacidin’s recent positive topline findings seen in both Inflammatory Bowel Disease (IBD) and Oral Mucositis (OM), coupled with previously successful results achieved in Acute Bacterial Skin and Skin Structure Infection (ABSSSI), has delivered a complementary cross-indication scientific anchoring for each Brilacidin indication in the Company’s pipeline.
In particular, Brilacidin-OM received an exceptional degree of attention at the San Francisco shows, further adding to an already robust partnering matrix. Innovation is developing Brilacidin-OM under a FDA Fast Track designation as a novel therapeutic and recently met the primary endpoint in a Phase 2 trial for preventing severe OM as well as a key secondary endpoint by delaying the onset of severe OM. Brilacidin has effectively earned a leadership position as an easily-delivered oral rinse drug candidate in OM—what many analysts predict will become a $1 billion market opportunity within the next few years.
"What must be stressed is that Brilacidin is a mature, later-stage drug candidate with platform potential. It took the recent completion of two Phase 2 trials, in IBD and OM, to further validate the exceptional results achieved from our Phase 2b study in ABSSSI. These recent data, taken in aggregate, are what various actively engaged pharmaceutical companies have desired from us for some time—and they are what triggered a newfound flurry of inbound partnership discussions at the San Francisco conferences," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "Datasets now in hand, reflecting three successfully completed Phase 2 studies across which multiple endpoints were met, have brought the Company to an important inflection point regarding Brilacidin. In coming weeks, we look forward to advancing these discussions with attractive partnership / licensing scenarios, towards determining the best path forward for the Company and its loyal shareholders."
Biotech Showcase Event Recording
An audio file of the Corporate Overview given at 2018 Biotech Showcase, on January 8, in San Francisco, is now available and accessible on the Events and Presentations section of the Company’s website.
Brilacidin-OM (Phase 2 Trial Completed)
As announced earlier, the Company has completed a Phase 2 randomized, double-blind, placebo-controlled trial (see NCT02324335) evaluating Brilacidin’s ability, administered as an oral rinse, to prevent and attenuate OM in patients with Head and Neck Cancer (HNC) receiving chemoradiation with at least 55 Gy across 7 weeks. The study’s primary endpoint was met, with Brilacidin, as a preventative treatment, showing a clear reduction in the incidence of severe OM (SOM) (WHO Grade ≥ 3) compared to placebo. A key secondary endpoint in the trial, delaying the onset of SOM, also was met. The Company has begun exploring patient-friendly improvements to drug delivery (the use of sachets) and will be meeting with the FDA to determine next steps in the clinical development of Brilacidin-OM. Patents for Brilacidin-OM have also been granted globally, most recently in Europe. Worldwide, the potential market for OM, largely untapped, is estimated to be in excess of $1 billion, with the Company considered a top contender in this space.