Innovation Pharmaceuticals Provides Corporate Update Highlighting Upcoming Milestones and Events
BEVERLY, Mass., Sept. 20, 2018 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (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.
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About Innovation Pharmaceuticals
Innovation Pharmaceuticals Inc. (IPIX) is a clinical stage biopharmaceutical company developing a world-class portfolio of innovative therapies addressing multiple areas of unmet medical need, including inflammatory diseases, cancer, infectious disease, and dermatologic diseases. Brilacidin, a versatile compound with broad therapeutic potential, is in a new chemical class called defensin-mimetics. A Phase 2 trial of Brilacidin as an oral rinse for the prevention of Severe Oral Mucositis (SOM) in patients with Head and Neck Cancer, met its primary and secondary endpoints, including reducing the incidence of SOM. Positive results were also observed in a Phase 2 Proof-of-Concept trial treating patients locally with Brilacidin for Ulcerative Proctitis/Ulcerative Proctosigmoiditis. A Phase 2b trial of Brilacidin showed a single intravenous dose of the drug delivered comparable outcomes to a seven-day dosing regimen of the FDA-approved blockbuster daptomycin in treating Acute Bacterial Skin and Skin Structure Infections. Kevetrin is a novel anti-cancer drug shown to modulate p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations, and has successfully completed a Phase 2 trial in ovarian cancer. Prurisol, an oral psoriasis drug candidate acting through immune modulation and PRINS reduction, has now completed a Phase 2b trial and is awaiting statistical analysis. More information is available on the Company website at www.IPharmInc.com.
Forward-Looking Statements: This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 including statements concerning projected timelines for the initiation and completion of clinical trials, our future drug development plans, other statements regarding future product developments, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks, uncertainties and assumptions that could cause the Company’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward-looking statements. The Company has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are the Company’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that the Company’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in the Company’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. The Company undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
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