The mouth is highly susceptible to the toxic effects of chemotherapy and radiation treatments necessary to fight many types of cancer, particularly head and neck cancer. There are currently no therapies approved by the U.S. FDA to prevent oral mucositis, a painful and often debilitating side effect of chemoradiation characterized by ulceration and infection of mucosal tissue subsequent to being broken down by cancer treatment. Innovation Pharmaceuticals (OTCQB:IPIX) is aiming to become the first company to bring a preventative oral mucositis (OM) drug to market, saying on Monday morning that it has completed patient enrollment in a mid-stage trial of Brilacidin-OM, an oral rinse aimed at reducing the onset and duration of OM in head and neck cancer patients receiving chemoradiation.
Brilacidin is the lead compound in the Beverly, Massachusetts-based company's novel defensin-mimetic franchise. The company is also developing other experimental drugs for solid tumors (Kevetrin - phase 2 for ovarian cancer) and dermatological conditions (Prurisol - phase 2 for psoriasis). The defensin-mimetic compounds have been heralded for their diverse mechanism of action, which include antibiotic, anti-inflammatory and immunomodulatory properties to potentially treat an array of diseases and conditions. Innovation previously completed a Phase 2b study of intravenous Brilacidin for severe skin infections known as ABSSSI. Another mid-stage trial for the inflammatory bowel diseases ulcerative proctitis / proctosigmoiditis last month produced compelling results in clinical remission of disease.
A total of 61 patients have been enrolled in the oral mucositis study. Those in the treatment group use Brilacidin-OM as an oral rinse daily for seven weeks, while the placebo group is administrated a water rinse. The WHO Grading system will be used to evaluate patients at 7 and 11 weeks to define incidence and severity for primary and secondary outcomes.
In March, the company - known as Cellceutix Corp. at the time before a name change in June - reported a marked reduced rate of severe oral mucositis in patients treated with Brilacidin-OM versus placebo in a preliminary look evaluating 19 patients in the study. At that time, 22% of patients (2 of 9) treated with Brilacidin-OM exhibited severe OM, while 70% of patients (7 of 10) in the placebo group showed severe OM.
There is a substantial market opportunity for a prophylactic, oral treatment for oral mucositis, considering over 500,000 Americans are affected annually by the condition, which can result in pausing or discontinuing cancer treatment and add greatly to the economic burden. Globally, the market is estimated to top $1 billion annually, with no clear market leader and patients forced to look rely upon treatments like "magic mouthwashes" that only reduce the symptoms rather than treat the root of the condition.
Shares of IPIX are trading up about 4 percent to 83 cents in early morning trading on Monday. It's not uncommon for Wall Street to have a relatively muted response on enrollment completion, with interest generally increasing as the time line for top-line data shortens, which is currently expected during the October to December quarter.
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