Innovation Pharmaceuticals Inc (OTCMKTS:IPIX) is a biopharma play gunning for the IBD market. IPIX has been red hot since late June in anticipation of clinical results. Accordingly, the most recent catalyst driving shares of the stock is the company’s announcement that a majority of patients treated with Brilacidin achieved Clinical Remission in its Phase 2, open-label, Proof-of-Concept (PoC) clinical trial evaluating Brilacidin for mild-to-moderate Ulcerative Proctitis / Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD).
According to the release, “Brilacidin is being developed as a novel, non-corticosteroid, non-biologic treatment, with formulation development plans including oral tablets for the treatment of Ulcerative Colitis and Crohn’s Disease and foam and/or gel for the treatment of UP/UPS.” The punchline here is this: Topline results, which include additional detailed review of patient data in Cohort A and Cohort B following interim analysis, showed favorable Clinical Remission rates that were similar across cohorts.
Innovation Pharmaceuticals Inc (OTCMKTS:IPIX) bills itself as an early-stage developmental biopharmaceutical company with six pharmaceutical compound candidates that are designed for treatment of diseases which may be either existing or diseases identified in the future.
The Company will initially spend most of its efforts and resources on its anti-cancer compound, Kevetrin, for the treatment of head and neck cancers.
According to company materials, “The Company is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. The Company believes it has a world-class portfolio of first-in-class lead drug candidates and is now advancing them toward market approval, while actively seeking strategic partnerships. The Company’s Psoriasis drug candidate Prurisol completed a Phase 2 trial and the Company more recently launched a Phase 2b study. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. The Company’s anti-cancer drug Kevetrin successfully concluded a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center, and the Company has commenced a Phase 2 study in Ovarian Cancer. In the laboratory, Kevetrin has been shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Brilacidin, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative Oral Mucositis (OM) by more than 94% compared to placebo.
“The Company is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of OM in patients with head and neck cancer; interim results have shown a marked reduction in the incidence of severe OM (WHO Grade ≥ 3). The Company’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infection, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (“superbugs”). In an ongoing Phase 2 open label Proof-of-Concept trial, favorable interim results have been observed in the first two cohorts of patients treated with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS), two types of Inflammatory Bowel Disease (IBD). The Company has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna.”
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In the company’s press release, two comments stood out to us:
“As a practicing gastroenterologist, it’s extremely exciting to see Brilacidin’s emergence as a possible novel treatment for Inflammatory Bowel Disease. Brilacidin’s unique mechanism of action and compelling clinical trial results support its potential,” said Francis A. Farraye, MD, MSc, Clinical Director, Section of Gastroenterology at Boston Medical Center, Professor of Medicine at Boston University School of Medicine and Scientific Advisor to Innovation Pharmaceuticals. “There exists a large unmet medical need in treating patients with Inflammatory Bowel Disease given its complex pathogenesis and high degree of variability in how patients respond to a given treatment. I look forward to continuing to work closely with the Innovation Pharmaceuticals team as they advance Brilacidin in the treatment of IBD.”
Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals, commented: “We are incredibly pleased with the successful completion of this trial and the dataset that we now have in-hand. To see such strong results with a basic formulation adds further credibility to where we believe we can take Brilacidin in treating the full continuum of IBD, particularly when optimally formulated and administered. Combined with the Brilacidin data for treating Oral Mucositis as a preventative medicine, we now have two solid anchors supporting Brilacidin’s considerable and diverse therapeutic potential.”
Traders will note 37% during the past month in terms of shareholder gains in the company, a rally that has pushed up against longer standing distributive pressure in the stock. However, IPIX has a history of dramatic rallies. Furthermore, the name has witnessed a pop in interest, as transaction volume levels have recently pushed 24% over the long run average.
At this time, carrying a capital value in the market of $138.9M, IPIX has a significant war chest ($5.6M) of cash on the books, which stands against about $2M in total current liabilities. The company is pre-revenue at this point. You can bet we will update this one again as new information comes into view. For continuing coverage on shares of $IPIX stock, as well as our other breakout stock picks, sign up for our free newsletter today and get our next hot stock pick!
Disclosure: we hold no position in $IPIX, either long or short, and we have not been compensated for this article.
