Innovation Pharmaceuticals Reports on Successful Phase II Trial of Brilacidin-OM for Oral Mucositis

April 9, 2018

Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to report further data analysis from its successfully completed Phase 2 clinical trial of Brilacidin-OM (see NCT02324335) for the indication of decreasing the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation.

For the Modified Intent-to-Treat (mITT) population, Brilacidin-OM in the aggressive chemotherapy regimen reduced the incidence of SOM by 65.0% ([incidence control- incidence active]/incidence control) as compared with placebo (Brilacidin: 25.0%; placebo: 71.4%; p=0.0480). For the Per Protocol (PP) population, Brilacidin-OM in the aggressive chemotherapy regimen similarly reduced the incidence of SOM by 80.3% as compared with placebo (Brilacidin: 14.3%; placebo: 72.7%; p=0.0249). Treatments appeared well-tolerated with good safety.

“We are delighted to see Brilacidin-OM demonstrate such high, statistically significant efficacy in patients receiving aggressive treatment for HNC,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Reducing incidence of SOM sets the gold standard and is key to capturing the large HNC market currently lacking any approved drugs.

Oral mucositis is a serious complication associated with chemotherapy and radiation used to treat Head and Neck cancer. The majority of oral cancer patients receiving chemotherapy in combination with radiation will experience at least some degree of mucositis. It can lead to several problems, including pain, nutritional problems as a result of inability to eat, and increased risk of infection due to open sores in the mucosa. It has a significant effect on the patient’s quality of life and can be dose-limiting (i.e., requiring a reduction in subsequent chemotherapy doses).

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