BEVERLY, MA – December 18, 2017 (GLOBE NEWSWIRE) Innovation Pharmaceuticals, (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today is pleased to provide an update on the developmental plan for Brilacidin, its first-in-class defensin-mimetic drug candidate, for the prevention and treatment of Oral Mucositis (OM). On December 11, 2017, the Company released topline data from a Phase 2 trial. The study met its primary endpoint of reducing the incidence of severe OM experienced by patients receiving chemoradiation for treatment of Head and Neck Cancer (HNC).
Oral Mucositis is a disease which is largely unfamiliar to the general public, many of whom haven’t witnessed the harsh side effects of OM first hand— namely extreme difficulty swallowing and painful sores in the mouth that can be so intense that cancer treatment must be stopped and a feeding tube inserted. There are currently no approved drugs for the prevention of severe OM in patients receiving chemoradiation treatment of HNC. Moreover, OM is a consequence of therapy for an array of cancers, not just HNC, where the incidence rate is particularly high.
Significant value inflection point for shareholders
Innovation Pharmaceuticals’ Brilacidin is now anchored in OM, representing a value inflection point for shareholders, as further supported by its lead positioning in an untapped $1 Billion market. “Anchored” is an industry term indicating a drug has delivered a meaningful response in a clinical setting for a specific disease along with good apparent safety and toleration. As such, Brilacidin-OM now represents a significant asset to the company. The next steps will be aimed at defining the most appropriate development plan to complete its evaluation prior to submission for marketing approval. This will involve consultation with the FDA and other health authorities worldwide, once full efficacy and safety endpoint data are available from the recent clinical trial.
Towards commercial planning, the Company has begun exploring potential unit dose drug product packaging in the form of a sachet. Sachets, which people are very familiar with and use on an almost daily basis (e.g., sugar packets, artificial sweeteners) increasingly are being developed as a novel means of patient-friendly, drug delivery. Manufacturing plans for drug substance appropriate for late phase testing and eventual market introduction are also underway.
As there are currently no approved drugs for prevention of severe OM in patients receiving chemoradiation treatment of HNC, management opinion is that Brilacidin-OM has the potential to rapidly assume a lead position after market introduction. This perspective is shared by multiple Pharma companies, potential partners the Company currently is in active discussions with, equally interested in the continued development and eventual market introduction of Brilacidin-OM worldwide.
“I am extremely proud that our team has achieved this very important milestone in cancer care and I feel very optimistic for the future. There is an urgent need for a drug such as Brilacidin to help cancer patients facing the threat of OM. We will be pursuing every option available to us toward providing these patients with a new therapeutic option,” commented Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “I have spoken with family members of patients dealing with OM and to hear the pain and suffering is simply heart-wrenching. I envision a day where doctors will have a viable option for preventing and treating severe OM and if Brilacidin-OM could be that drug, it would be a considerable accomplishment for the Company, our shareholders and the entire oncology industry.”