BEVERLY, MA – May 9, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to inform shareholders that the Company 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.
“The Company would like to thank the trial’s patients who volunteered for this study. It is often a difficult decision for a patient to volunteer for a clinical trial with a placebo arm—and gratitude is owed to all who participated in the face of their respective cancer battles,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer of Innovation Pharmaceuticals. “We would also like to thank our shareholders and institutional partners that have made it possible to advance Innovation’s drug candidates.”
“Given the notable interest from global and specialty pharmaceutical companies that we have received following recent Brilacidin-OM data releases, we continue to carefully assess all of our potential alliance opportunities—toward cementing the best pathway forward,” said Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals. “The expedient advancement of Brilacidin-OM into later clinical development is a priority, as is the broader expansion of the complete Brilacidin Franchise.”
Summary of Brilacidin-OM Phase 2 Study Results
Key Efficacy Outcomes were:
· Reduced Incidence of Severe OM (Primary Endpoint)
o Placebo 60.0%, reduced to Brilacidin 42.9% [Modified Intent to Treat (mITT) Population].
o Placebo 60.0%, reduced to Brilacidin 36.8% [Per Protocol (PP) Population].
· Delayed Onset of Severe OM (Secondary Endpoint)
o 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)
o 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.
o 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
o Placebo 71.4%, reduced to Brilacidin 25.0% [mITT Population] (p=0.048).
o Placebo 72.7%, reduced to Brilacidin 14.3% [PP Population] (p=0.025).
· Delayed Onset of Severe OM, 21-day Cisplatin Regimen subset
o 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.
The ‘Blue Sky’ Commercial Opportunity in Severe Oral Mucositis
There is no drug approved to prevent or treat Severe OM in patients with HNC. This is not due to lack of effort, however, with many companies having tried to address the unmet medical need with limited success (see ClinicalTrials.gov). According to posted information, over 250 clinical studies (as of 05-May-2018) have been, or are being, conducted targeting Oral Mucositis—indicative of the substantial pharmaceutical industry effort and investment toward attempting to identify new OM treatments.
The commercial potential for Brilacidin-OM in HNC is substantial and untapped, with no effective drug currently approved worldwide. In the U.S. alone, the annual incidence of HNC is estimated to be approximately 65,000 new cases, and worldwide, these numbers approach approximately 750,000 new cases each year. With Brilacidin-OM, Innovation Pharmaceuticals is positioned to fill a substantial void in supportive cancer care by reducing the incidence of Severe OM in HNC, making a considerable difference to the general well-being of these patients.
About Unmet Need in Treating Severe Oral Mucositis
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.
It is widely acknowledged that there is a large unmet need for novel therapeutics in this area, with many interventions limited in their application and/or ranging widely in quality and with conflicting results, as conveyed in the Multinational Association of Supportive Care in Cancer (MASCC) and International Society of Oral Oncology (ISOO) Clinical Practice Guidelines for the Management of Mucositis Secondary to Cancer Therapy.