Company progresses through first stage of review by European Medicines Agency (EMA) regarding Scientific Advice for planned Phase 3 Program
BEVERLY, MA – April 23, 2019 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage pharmaceutical company, is pleased to inform shareholders of a recent publication in the Journal of the American Medical Association (JAMA), a leading independent, international journal for medical professionals, detailing data from a clinical study1 on the effect of doxepin mouthwash or diphenhydramine-lidocaine-antacid mouthwash vs placebo on radiotherapy-related oral mucositis pain. A corresponding editorial2, titled, “The Search for an Effective Therapy and Pain Relief for Oral Mucositis,” accompanied the article. Both the published JAMA article and editorial are highly relevant for development of Brilacidin oral rinse under a U.S. Food and Drug Administration (FDA) Fast Track designation as a new drug candidate to decrease the incidence of severe Oral Mucositis (OM) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
The clinical study recruited 275 patients randomized 1:1:1 to receive: doxepin; diphenhydramine-lidocaine-antacid; or placebo mouthwash. Both active mouthwashes assessed in the study proved to be of minimal help during the first 4 hours after administration in treating radiation-induced mucositis. While statistically improvements were observed in relation to pain scores, they were not deemed clinically important (minimal clinically important difference was a 3.5-point change). Compared with placebo, diphenhydramine-lidocaine-antacid led to a 3.0-point improvement (95% CI 0.1-5.9, P=0.004) while the doxepin mouthwash led to a 2.9-point improvement (95% CI 0.2-6.0, P=0.02). Doxepin but not diphenhydramine-lidocaine-antacid mouthwash was also associated with drowsiness, unpleasant taste, and higher frequency of stinging or burning than placebo.
The accompanying editorial emphasized the study’s limitations: “The distinction between statistical significance and clinical importance is relevant in this study, and the findings suggest that pain relief was short-term and limited among many of the patients.” Closing with the observation: “[T]he search for an effective, safe therapy for oral mucositis and its associated pain needs to continue.”
“As the JAMA mouthwash study results show, it’s an ongoing tragedy that cancer patients must currently rely on, at best, minimally effective short-term symptom relief when trying to manage their oral mucositis,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Our clinical testing of Brilacidin oral rinse in Head and Neck Cancer patients undergoing chemoradiation, to date, has shown that it markedly decreases the incidence of severe oral mucositis. This is in stark contrast to the limited benefit provided by the mouthwashes in the quoted article, a current common treatment approach, as well as the similarly minimally beneficial, largely palliative, coating agents in clinical use. A potentially transformative treatment, Brilacidin, after years of largely ineffective treatment attempts by others, may be on the cusp of helping to solve this global unmet need in cancer care.”
The Company continues to build upon its recent productive End-of-Phase 2 meeting with the FDA through ongoing interaction with the European Medicines Agency (EMA). The first stage of review by the EMA regarding the Company’s application for Scientific Advice was recently completed. The Company looks forward to advancing its planned Phase 3 clinical development for the Brilacidin oral rinse program, in both the United States and Europe.
About Brilacidin Phase 2 Results in Treating Severe Oral Mucositis
The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving an aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is the standard of care. In this patient population, the incidence of SOM was reduced to 25.0% in the modified Intent-to-Treat (mITT) population, versus 71.4% of patients on placebo. In the Per Protocol (PP) patient group, incidence of SOM dropped to 14.3% for patients receiving Brilacidin oral rinse, compared to 72.7% among those receiving placebo.
The completed Phase 2 study met its primary endpoint, showing a reduction of SOM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of SOM and in delaying the onset of SOM.
Linked below is information, published in a blog on the Company’s website, elaborating on how Brilacidin is positioned compared to other investigational Oral Mucositis drugs currently in clinical development.