Innovation Pharmaceuticals (OTCQB:IPIX)announced on 9/24/18 the publication of a comparative perspective on the development of Brilacidin for the prevention of severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC). The late-stage drug candidate, one of the few drugs currently in clinical development shown to reduce the incidence of SOM, further advantaged by its convenient mode of administration as an oral rinse, is emerging as clearly differentiated and highly promising.
The title of the comparison is ,“Brilacidin for Oral Mucositis: At-a-Glance Comparative Data Presentation with Other Investigational OM Drugs” http://www.ipharminc.com/new-blog/2018/9/24/brilacidin-for-oral-mucositi...
Various drug companies in the OM space are conducting mid-and-late-stage clinical trials, with one private company recently raising $150 million to fund further development of its OM drug candidate. We believe the magnitude of such a sizable investment commitment confirms our own assessment that an effective drug to prevent—or even reduce the duration of SOM—has the potential to capture a substantial new market.
OM represents a large unmet medical need and is estimated to be a $1 billion market opportunity, increasingly garnering substantial pharmaceutical industry interest. Patients desperately await effective OM treatments, as relayed in a video on the painful and debilitating side-effects of the condition published on the “Healthy Body, Healthy Mind” website.
“The results of the Brilacidin OM Phase 2 are compelling,” said Company Scientific Advisor and OM expert, Stephen T. Sonis, DMD, DMSc, of Brigham and Women's Hospital. “The lack of preventive or definitive treatment options for patients at risk of, or suffering from, OM is a consistent source of patient misery and leads to costly and clinically significant downstream consequences. I enthusiastically anticipate the next phase in Brilacidin’s clinical development.”
Brilacidin is administered in an oral rinse. This is viewed as a significant advantage over the administration route (ex IV) of some of the other drugs in development.
Innovation Pharmaceuticals has successfully completed a randomized, placebo-controlled Phase 2 clinical trial (see NCT02324335). Data analysis showed that Brilacidin delivered a statistically significant therapeutic benefit by decreasing the incidence of SOM (WHO Grade ≥3) in HNC patients receiving the more aggressive chemotherapy regimen—cisplatin administered in high concentration (80-100 mg/m2), approximately every 21 days (q3wk)—as compared to lower concentrations of cisplatin (30-40 mg/m2) administered weekly. The q3wk dosing regimen aligns with the current standard-of-care for cisplatin chemotherapy. Other previously released results indicate that Brilacidin also delayed the onset and reduced the duration of SOM.
Based on these consistent and compelling trial results across multiple endpoints, the Company believes Brilacidin occupies a lead position among OM drug candidates being evaluated in clinical pipelines. Most potential competitor drugs target mainly symptom relief and not the prevention of SOM, and/or are disadvantaged by not having as patient-friendly modes of delivery (e.g., IV). Given Brilacidin is administered as a convenient oral rinse, with plans to package it in an easily transportable sachet form, the Company believes it would be attractive to both doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse one day gain regulatory approval.
There currently are no FDA-approved drugs for the prevention of SOM (WHO Grade ≥ 3) in HNC patients receiving chemoradiation. The additional expenses incurred by patients suffering from SOM are estimated to be as high as $18,000 to $25,000 per case in the U.S. when hospitalization is required. These factors contribute to SOM qualifying as an area of significant unmet medical need.
Brilacidin is Innovation's lead drug candidate in its defensin mimetic franchise. Modeled after Host Defense Proteins (HDPs), the “front-line” of defense in the immune system, it is a small, non-peptidic, synthetic molecule that kills pathogens swiftly and thoroughly. Just as importantly, Brilacidin also functions in a robust immunomodulatory capacity, lessening inflammation and promoting healing.
Brilacidin is also being developed as an oral tablet for Ulcerative Colitis and Crohn's Disease.