On December 17, 2018 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, reported that the Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting concerning the continuing development of Brilacidin oral rinse to decrease the incidence of Severe Oral Mucositis (SOM) in Head and Neck Cancer (HNC) patients receiving chemoradiation (Press release, Innovation Pharmaceuticals, DEC 17, 2018, View Source [SID1234532085]). Brilacidin oral rinse is being developed under FDA Fast Track designation for Oral Mucositis (OM).
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Both parties agreed to an acceptable Brilacidin Phase 3 development pathway, including studying Brilacidin oral rinse effects on SOM when cisplatin is administered in higher concentrations (80-100 mg/m2) every 21 days, and at lower concentrations (30-40 mg/m2) administered weekly as part of the chemoradiation regimen.
Once official meeting minutes are received from the FDA, the Company expects to release more details regarding planned Phase 3 trials of Brilacidin as a novel oral SOM treatment. Conducted in accordance with the FDA guidance, the goal of the upcoming studies will be to satisfy requirements for a New Drug Application and, ultimately, obtain marketing approval of Brilacidin for SOM. Management further intends to solicit international regulatory bodies for the purpose of expanded registration globally.
"Our interactions with the FDA have been highly collaborative and constructive, providing us with clear guidance to help inform our Phase 3 development plans," commented Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. "We are in alignment as to necessary key pivotal trial design features and Phase 3 clinical outcomes needed to support a NDA filing. We look forward to continue working closely with FDA on our Brilacidin oral rinse program as we prepare to enter the pivotal stage of clinical evaluation."
"This is an extremely exciting moment for Innovation Pharmaceuticals and its shareholders," commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. "In Brilacidin oral rinse, we now have a Phase 3-ready drug candidate targeting an area of large unmet need—comprising a worldwide annual market opportunity estimated to approach $1 billion—for which currently there are no FDA-approved treatments. Brilacidin is further advantageously differentiated from the two other OM drug candidates in Phase 3 testing which require being taken intravenously, whereas Brilacidin is easily administered as an oral rinse and conveniently packaged in sachet form, similar in design to a sugar packet. With a sachet, patients simply would mix the contents of the Brilacidin sachet with water for a quick-and-easy treatment at home or on-the-go."
Mr. Ehrlich continued, "This result further validates the breadth of the Brilacidin franchise. Our novel defensin-mimetic drug candidate is anchored with mid-and-late-stage trials in three clinical indications—oral mucositis, inflammatory bowel disease, and serious skin infections—and planned extensions into dermatological diseases, such as atopic dermatitis and acne. Effectively, we have a multi-indication drug platform in Brilacidin, now planning for Phase 3 testing for the first indication, thus moving us a significant step closer to bringing Brilacidin to market."
About Brilacidin Phase 2 OM Trial/Comparison with Other OM Drugs in Development
The Company’s Brilacidin oral rinse demonstrated a strong therapeutic benefit in patients receiving the aggressive chemotherapy regimen (cisplatin administered 80-100 mg/m2, every 21 days), which currently is in common use. In this patient population, incidence of Severe OM (WHO Grade ≥ 3) was reduced to 25.0 percent in the modified Intent-to-Treat (mITT) population, versus 71.4 percent of placebo patients. In the Per Protocol (PP) patient group, incidence of Severe OM dropped to 14.3 percent for patients receiving Brilacidin, compared to 72.7 percent among those receiving placebo.
The completed Phase 2 study (see NCT02324335) met its primary endpoint, showing a reduction of Severe OM incidence versus placebo, as well as beneficial treatment effects in reducing the duration of Severe OM and in delaying the onset of Severe OM. Furthermore, Brilacidin showed a favorable safety profile and -was well-tolerated.
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 in clinical development.
View Source
About Brilacidin and Severe Oral Mucositis
There currently are no FDA-approved drugs for the prevention of Severe OM (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. According to published statistics, the number of new annual HNC cases in the U.S. is estimated to be 65,000, and worldwide, ~750,000 cases. Between 60 and 70 percent of these HNC patients typically will develop Severe OM, with the overall incidence of HNC patients developing some grade of OM (WHO Grades 1 to 4) approaching 100 percent. Because it cannot be predicted which patients will develop SOM, a preventative treatment, such as Brilacidin oral rinse, would begin in all patients as soon as starting chemoradiation and continue until its completion (typically a seven-week course). 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 both to doctors and patients—likely translating to widespread and rapid market adoption should Brilacidin oral rinse gain regulatory approval.