On December 18, 2017 Innovation Pharmaceuticals, (IPIX) ("the Company"), a clinical stage biopharmaceutical company, reported 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) (Press release, Innovation Pharmaceuticals, DEC 18, 2017, View Source [SID1234522691]). 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).

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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."

About Brilacidin

Brilacidin is Innovation Pharmaceuticals’ 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. Due to its unique properties, the Company is studying Brilacidin’s effect on Oral Mucositis (under Fast Track designation) and on Ulcerative Proctitis / Proctosigmoiditis (UP/UPS) in Phase 2 trials. Additional trials of Brilacidin are planned in other conditions, including: Atopic Dermatitis, Hidradenitis Suppurativa and Acne. Brilacidin is also being developed under FDA’s Qualified Infectious Disease Product (QIDP) designation as an antibacterial product for Acute Bacterial Skin and Skin Structure Infection (ABSSSI)—qualifying it for Fast Track and possible Priority FDA Review and an extra 5 years of United States market exclusivity upon drug approval.

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About Brilacidin-OM

Innovation Pharmaceutical’s first-in-class immunomodulatory drug candidate, Brilacidin, targets the prevention of severe Oral Mucositis (OM)—a common and debilitating side-effect of receiving chemoradiation therapy—in Head and Neck Cancer. Each year, OM affects hundreds of thousands of patients worldwide. Only a limited number of OM treatments are available, most of which are palliative in nature. A Phase 2 randomized, placebo-controlled clinical trial of Brilacidin-OM (see NCT02324335) has been recently completed in which topline results demonstrate a reduced rate of severe OM (WHO Grade >3) in patients treated with Brilacidin-OM compared to those on placebo.

About Oral Mucositis

Oral Mucositis (OM) is a frequent, painful and debilitating complication of chemoradiation. Head and Neck Cancer (HNC) patients—comprising an estimated 65,000 newly diagnosed cases in the U.S. alone in 2017, and an estimated 700,000 worldwide (source:GLOBOCAN)—are at the greatest risk of developing OM (a 90 to 100 percent rate of occurrence). By 2030, the global incidence of HNC cases is expected to exceed 1 million per year. Moreover, between 25 and 60 percent of cancer patients, regardless of cancer type, also will experience OM. Characterized by inflammation and ulceration, patients suffering from OM are often unable to speak and eat (requiring the insertion of a feeding tube) and are more susceptible to infections, with severe cases leading to hospitalization at increased treatment costs of up to $25,000. There currently are no approved medications for the prevention of OM in the HNC population, with only limited palliative care options available. Worldwide, the potential marketfor OM is expected to exceed $1 billion in the next few years.