BEVERLY, MA – September 20, 2018 (GLOBE NEWSWIRE) Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, is pleased to provide a corporate update on upcoming milestones and events across its clinical pipeline of first-in-class drug candidates, Brilacidin, Prurisol and Kevetrin.
“Our clinical assets are both highly promising and well-diversified,” said Arthur P. Bertolino, MD, PhD, MBA, President and Chief Medical Officer at Innovation Pharmaceuticals. “Near-term strategic clinical priorities remain: to work closely with the FDA and other regulatory authorities to align on the remaining development plan necessary for Brilacidin in Oral Mucositis; to analyze the Prurisol Phase 2b data in Psoriasis; and, as additional funding becomes available, to commence work on new product formulations—1) an oral pill for Kevetrin in Ovarian Cancer; 2) an oral pill for Brilacidin in IBD; and a topical application for Brilacidin in Atopic Dermatitis and Acne.”
“The Company’s pipeline is as mature as it has ever been,” noted Leo Ehrlich, Chief Executive Officer of Innovation Pharmaceuticals. “We have made substantial clinical progress with what we have accomplished to date, and remain committed to translating this into shareholder value. With partnering discussions ongoing, as well as active efforts underway to secure additional sources of capital, the prospects of our loyal shareholders are of paramount concern and front-of-mind as we strive to execute on these opportunities. We will continue to work tirelessly on their behalf as we advance the development of our clinical drug candidates.”
Upcoming Milestones and Events
Brilacidin for Oral Mucositis
· In coming weeks, the Company plans to submit a request for an End-of-Phase 2 meeting with the Food and Drug Administration (FDA) to discuss appropriate next steps in the development of Brilacidin for the treatment of Oral Mucositis (OM), which has already been granted Fast Track designation. A Breakthrough Therapy Designation application is currently under review with the FDA. OM represents a large unmet medical need and is estimated to be a $1 billion market opportunity. The Company plans to focus its efforts on the advancement of Brilacidin oral rinse for the prevention and control of severe Oral Mucositis (SOM) (WHO Grade ≥3) in Head and Neck Cancer (HNC) patients receiving the most aggressive regimen of chemoradiation, with chemotherapy administered in high concentration (80-100 mg/m2), approximately every 21 days (q3wk), as clear efficacy and good toleration were seen in treating this patient population.
Brilacidin for Inflammatory Bowel Disease
· Building on the successfully completed Proof-of-Concept (PoC) trial in treating distal colitis, the Company will be preparing a pre-Investigational New Drug submission (pre-IND) to the FDA to discuss Brilacidin’s ongoing clinical development for the treatment of IBD. Additional efforts are planned to develop an oral formulation of Brilacidin so that the drug can be administered more uniformly in the GI tract toward treating more extensive forms of IBD, such as Ulcerative Colitis and Crohn’s Disease.
· On November 13, 2018, the Company will present Brilacidin for Inflammatory Bowel Disease at the inaugural “IBD Innovate” conference, at the invitation of the Crohn’s & Colitis Foundation which will be hosting the event at the New York Academy of Medicine in New York, NY. The scientific poster—titled “Brilacidin for Inflammatory Bowel Disease: A Novel, Non-Corticosteroid, Non-Biologic Drug Candidate in Clinical Development”—to be presented at the conference will be available in the Events and Presentations section of the Company website on the day of the presentation.
Prurisol for Psoriasis
· A top priority of the Company remains to unblind and analyze topline results from its completed Phase 2b trial (see NCT02949388) of oral Prurisol for the treatment of Moderate-to-Severe Chronic Plaque Psoriasis. Enrolling up to 199 patients, and based upon the protocol for 12 weeks of Prurisol treatment and an additional patient follow-up for 4 weeks, the study builds on a prior successfully completed Phase 2 trial of oral Prurisol in Mild-to-Moderate Chronic Plaque Psoriasis. A novel Psoriasis drug, particularly one that is oral, safe and effective, which could expand patient and physician choices for treatment, likely would command significant market value.
Kevetrin for Ovarian Cancer
· Next steps, building on our successful completed Phase 2a study in Ovarian Cancer, are planned to focus on completion of toxicology studies necessary for the oral formulation of Kevetrin and to prepare an appropriate oral dosage form to further evaluate the drug candidate’s clinical benefits and safety.