Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), announced on 5/9/18 that it has concluded its review of all data outputs and corresponding analyses from its successfully completed Phase 2 Brilacidin-OM trial (see NCT02324335) for the indication of decreasing the incidence of Severe Oral Mucositis (Severe OM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving chemoradiation.
Summary of Brilacidin-OM Phase 2 Study Results
Key Efficacy Outcomes were:
Reduced Incidence of Severe OM (Primary Endpoint)
Placebo 60.0%, reduced to Brilacidin 42.9% [Modified Intent to Treat (mITT) Population].
Placebo 60.0%, reduced to Brilacidin 36.8% [Per Protocol (PP) Population].
Delayed Onset of Severe OM (Secondary Endpoint)
For those patients in the Brilacidin group who did experience Severe OM, onset occurred generally later during radiation therapy.
Reduced Duration of Severe OM (Secondary Endpoint)
Severe OM median duration was 0.0 days for Brilacidin (mITT and PP Populations), indicating that more than half of all patients on active treatment did not experience Severe OM.
Overall Severe OM median durations for placebo were 3.0 days and 5.5 days for the mITT and PP Populations, respectively.
Brilacidin was more effective in decreasing the incidence of Severe OM in patients receiving the more aggressive chemotherapy regimen – cisplatin administered in a higher concentration (80-100 mg/m2), approximately every 21 days – as compared to lower concentrations of cisplatin (30-40 mg/m2) administered weekly.
Reduced Incidence of Severe OM, 21-day Cisplatin Regimen subset
Placebo 71.4%, reduced to Brilacidin 25.0% [mITT Population] (p=0.048).
Placebo 72.7%, reduced to Brilacidin 14.3% [PP Population] (p=0.025).
Delayed Onset of Severe OM, 21-day Cisplatin Regimen subset
The time to onset of Severe OM was delayed with Brilacidin treatment compared to placebo, even more markedly in the 21-day cisplatin regimen subgroup.
A 65.0% (mITT Population) and 80.3% (PP Population) relative risk reduction ([incidence control- incidence active]/incidence control) in the incidence of Severe OM was achieved with Brilacidin compared to placebo, for the approximately every 21 days cisplatin regimen subset. The academic literature indicates that a once-every-3-weeks cisplatin regimen, versus once-a-week, largely remains the recommended dosing schedule for the treatment of HNC.
Innovation's CEO, Leo Ehrlich, said the company has received interest from global and specialty pharmaceutical companies following the recent release of positive Brilacidin data. “We continue to carefully assess all of our potential alliance opportunities—toward cementing the best pathway forward,” he said. “The expedient advancement of Brilacidin-OM into later clinical development is a priority, as is the broader expansion of the complete Brilacidin Franchise.”
Severe Oral Mucositis is a serious, costly, complex and frequent complication of treatment for HNC. In cases of Severe OM, patients cannot eat solid food (Grade 3) and cannot consume either solids or liquids (Grade 4)—a situation that can result in, most critically, suspension of cancer therapy. As noted in a video on Severe OM published on the “Healthy Body, Healthy Mind” website, negative effects of developing Severe OM can also be overwhelming to a patient’s physical well-being and positive mental attitude.
Severe OM incidence rates in HNC can range from 60-70 percent, on the low end, to over 90 percent. Further, morbidity attributable to ulcerative and Severe OM can result in not just chemoradiation treatment interruption, but also placement of feeding tubes, and potentially greater mortality due to deleterious effects of subsequent treatment interruptions (worsening local tumor control and lower overall survival). Added health care costs attributable to Severe OM average ~$18,000 to $25,000 per case when patients require hospitalization.