Innovation Pharma Files Form 10-Q; Patient Enrollment in Phase 2 Clinical Trial of Brilacidin for COVID-19 Tops 70 Percent

Rhea-AI Summary

Innovation Pharmaceuticals (OTCQB:IPIX) filed its SEC Form 10-Q for Q1 2021, highlighting significant advancements in the development of Brilacidin, a drug candidate targeting COVID-19. Fast Track designation was granted by the FDA, and the ongoing Phase 2 trial has seen rapid patient enrollment, reaching over 70%. Brilacidin's multi-faceted therapeutic potential has been recognized, with robust antiviral research supporting its efficacy against SARS-CoV-2. Additionally, Alfasigma plans to initiate a Phase 2 trial for Ulcerative Proctitis, with Innovation Pharmaceuticals potentially receiving significant milestone payments.

Positive

• FDA granted Fast Track designation for Brilacidin for COVID-19.
• Enrollment in the Phase 2 trial for COVID-19 surpassed 70%.
• Brilacidin recognized for its antiviral, anti-inflammatory, and antimicrobial properties.
• Alfasigma plans a Phase 2 trial for Ulcerative Proctitis, indicating strong commercial interest.

Negative

• None.

WAKEFIELD, Mass., May 13, 2021 (GLOBE NEWSWIRE) -- Innovation Pharmaceuticals (OTCQB:IPIX) (“the Company”), a clinical stage biopharmaceutical company, today announces the filing of its SEC Form 10-Q (quarterly report), for the quarter ended March 31, 2021. During the quarter, the Company made substantive progress in the development of Brilacidin, Innovation Pharma’s flagship drug candidate in a new class of compounds called defensin-mimetics.

Of particular note, in January, the U.S. Food and Drug Administration (FDA) designated the investigation of Brilacidin for the treatment for COVID-19 as a Fast Track development program.
In February, recruitment began for the Company’s international Phase 2, ~120-patient, randomized, double-blind, placebo-controlled clinical trial evaluating Brilacidin for treatment of moderate-to-severe COVID-19 in hospitalized patients (see NCT04784897). Early in April, enrollment in the trial reached 25 percent. Upon review of safety data, per protocol, the independent Data Monitoring Committee (DMC) recommended increasing the dosing regimen of Brilacidin from 3 days to 5 days of treatment, which has been implemented and may further maximize Brilacidin’s therapeutic benefits. At the end of April, enrollment in the COVID-19 trial reached 50 percent, and as of today, the Company is pleased to report enrollment now exceeds 70 percent.

Since the COVID-19 outbreak, Brilacidin has garnered attention due to its unique 3-in-1 therapeutic potential—antiviral, anti-inflammatory, antimicrobial—to treat COVID-19 and associated complications. Extensive antiviral research conducted to date resulted in publication of findings related to Brilacidin’s anti-SARS-CoV-2 activity in Viruses, a peer-reviewed journal, with Brilacidin also selected for academic presentations, leading to added exposure for the Company. Further, an independent Machine Learning/Artificial Intelligence model used to screen 1,482 compounds ranked Brilacidin in the top three percent of compounds predicted to be the most effective against SARS-CoV-2, the virus responsible for COVID-19. The Company is encouraged by the Brilacidin antiviral data generated thus far, as it is supportive of Brilacidin’s potential to become a front-line antiviral treatment for COVID-19.

Also in the pipeline, Alfasigma S.p.A. (“Alfasigma”)—the licensee of worldwide rights to develop, manufacture and commercialize rectally-administered Brilacidin for treatment of Ulcerative Proctitis/Ulcerative Proctosigmoiditis (UP/UPS)—notified the Company, in April, of its intentions to commence, in 2021, a Phase 2 multinational clinical trial of Brilacidin for UP/UPS. Alfasigma has placed an order with the Company for Brilacidin drug substance needed for the trial, which the Company is in the process of supplying. Per the licensing agreement, Innovation Pharma is eligible to receive $24 million in upfront and milestone payments, and a 6 percent royalty (net sales), upon the successful marketing of Brilacidin for UP/UPS.

“It was a busy and productive quarter for us,” said Leo Ehrlich, Chief Executive Officer at Innovation Pharmaceuticals. “Patient enrollment in the Phase 2 study of Brilacidin for COVID-19 is moving along quickly, far faster in recruitment than other COVID-19 studies we’ve seen in industry reports. We are optimistic about Brilacidin’s COVID-19 treatment prospects, and are further encouraged by the broad spectrum antiviral properties Brilacidin is exhibiting based on ongoing lab research in multiple viruses.”

Ehrlich continued: “Elsewhere, it was exciting to learn that Alfasigma is planning to commence a Phase 2 trial of Brilacidin for treatment of UP/UPS this year, which complements our goal to develop oral Brilacidin in Inflammatory Bowel Diseases. That Alfasigma is investing substantial resources and monies in the clinical development of Brilacidin is a reassuring sign they continue to see therapeutic promise and commercial merit in Brilacidin in the area of IBD, as do we. Development work related to the formulation and manufacture of Brilacidin in capsule form is underway to support our Phase 2 trial in Ulcerative Colitis planned to commence this year. Additional work tied to starting, in 2022, a planned Phase 3 study of Brilacidin in Oral Mucositis is also in progress. We aim to maintain momentum across our clinical programs.”

Alerts 
Sign-up for Innovation Pharmaceuticals email alerts is available at: http://www.ipharminc.com/email-alerts/

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 diseases, and dermatologic diseases.

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 future drug development plans, clinical trials, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its impact on SARS-CoV-2 (COVID-19) and other viruses, as well as obtaining government regulatory approvals to commence clinical testing; other statements regarding future product developments, and markets, including with respect to specific indications, and any other statements which are other than statements of historical fact. These statements involve risks but not limited to risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the US and other jurisdictions; that prior test results may not be replicated in future studies and trials, 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 under securities purchase agreements; the Company’s vendors may not produce Brilacidin drug substance or dosing formulations in compliance with the Company’s specifications required for clinical trials; the fact that the Company’s licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments, or 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.

INVESTOR AND MEDIA CONTACTS 
Innovation Pharmaceuticals Inc. 
Leo Ehrlich 
info@ipharminc.com

FAQ

What are the latest developments for Innovation Pharmaceuticals and Brilacidin?

Innovation Pharmaceuticals announced significant progress in the development of Brilacidin, including FDA Fast Track designation and rapid enrollment in a Phase 2 trial for COVID-19.

What is the current enrollment status of the Brilacidin Phase 2 trial?

Enrollment in the Phase 2 trial for Brilacidin has exceeded 70% as of the press release date.

What potential does Brilacidin have against COVID-19?

Brilacidin has demonstrated multi-faceted therapeutic potential with antiviral, anti-inflammatory, and antimicrobial properties, making it a promising candidate for COVID-19 treatment.

What are the financial implications of the Alfasigma partnership for Innovation Pharmaceuticals?

Innovation Pharmaceuticals is eligible for $24 million in upfront and milestone payments from Alfasigma, along with a 6% royalty on net sales upon successful commercialization of Brilacidin.

What is the significance of the FDA Fast Track designation for Brilacidin?

The FDA Fast Track designation accelerates the development process for Brilacidin, allowing for more efficient communication with the FDA and potential priority review.