Innovation Pharmaceuticals Conducting Full Data Analysis of Phase 2 Brilacidin COVID-19 Trial Results to Support Brilacidin's Potential Inclusion in Government-Sponsored COVID-19 Trials

Rhea-AI Summary

Innovation Pharmaceuticals (OTCQB:IPIX) has announced a full data analysis of its Phase 2 Brilacidin COVID-19 clinical trial results, aiming for potential inclusion in larger government-sponsored trials. New in vitro data indicates Brilacidin's effectiveness as a dual-acting broad-spectrum inhibitor of coronaviruses. The study suggests that Brilacidin targets both viral and host factors, which may reduce resistance development. The Company possesses sufficient drug supply to continue clinical testing and aims to identify promising data to support future trials.

Positive

• Conducting full data analysis of Phase 2 trial results for Brilacidin.
• In vitro data shows Brilacidin can inhibit multiple coronaviruses.
• Potential inclusion in larger COVID-19 platform trials (e.g., U.K.'s CTAP program, NIH's ACTIV program).
• Sufficient supply of Brilacidin for further clinical testing.

Negative

• None.

Additionally, new in vitro data also show Brilacidin targets both viral proteins and host factors, suggesting Brilacidin would be less prone to developing resistance compared to other antivirals

WAKEFIELD, MA / ACCESSWIRE / November 12, 2021 / Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage biopharmaceutical company, today announced the Company is conducting full data analysis of the Phase 2 Brilacidin COVID-19 clinical trial results to support Brilacidin's potential inclusion in government-sponsored COVID-19 trials. The Company also is pleased to announce public release of new in vitro data based on extensive research by scientists at the University of Arizona and the University of California-San Francisco (UCSF), showing that Brilacidin functions as a dual-acting broad-spectrum inhibitor of coronaviruses.

Topline results for the Phase 2 Brilacidin COVID-19 clinical trial (see NCT04784897) have been reported. Complete analysis of trial results already has begun, with the aim to potentially identify positive trends in the data that could support Brilacidin for inclusion in larger COVID-19 platform trials, such as the U.K.'s CTAP program and the NIH's ACTIV program. The purpose of these programs is to prioritize development of promising COVID-19 therapeutics. Some COVID-19 drug candidates that did not meet their trial's primary endpoint, for example Relief Therapeutics' aviptadil, or those that showed inconclusive results in early clinical testing (e.g., anti-IL-6 drugs), have later gone on to be included in larger platform trials based on deeper analysis of trial results.

The Company's intent, should full analysis of the Brilacidin COVID-19 trial results yield promising data, is to submit Brilacidin for inclusion in these larger COVID-19 platforms. Sufficient intravenous Brilacidin drug supply is on hand to support further clinical testing of Brilacidin in COVID-19.

Highlights of New In Vitro Research

The new Brilacidin scientific findings, accessible as a preprint at the bioRxiv link provided below, are to be submitted for peer-review publication.

• Yanmei Hu, Hyunil Jo, William DeGrado, Jun Wang. Brilacidin, a COVID-19 Drug Candidate, Demonstrates Broad-Spectrum Antiviral Activity Against Human Coronaviruses OC43, 229E and NL63 Through Targeting Both the Virus and the Host Cell. bioRxiv 2021.11.04.467344; doi: https://doi.org/10.1101/2021.11.04.467344
  https://www.biorxiv.org/content/10.1101/2021.11.04.467344v1.full

University of Arizona and UCSF scientists characterized the antiviral activity of Brilacidin against multiple endemic human coronaviruses (HCoVs), including HCoV-OC43, HCoV-229E, HCoV-NL63, and SARS-CoV-2 pseudovirus, in multiple human cell lines.

Various mechanistic studies were performed to inform Brilacidin's antiviral properties, which showed Brilacidin exerts antiviral activity by interfering with viral attachment to host cells. It is theorized that positively-charged Brilacidin binds to negatively-charged Heparan Sulfate Proteoglycans (HSPGs) on the host cell surface, preventing viral attachment. HSPGs are important co-receptors through which many viruses, including SARS-CoV-2, gain entry into host cells.

In addition to exhibiting this blocking property, Brilacidin was also shown to target viral proteins directly, acting through a virucidal property. Brilacidin's hydrophobic characteristic, more than its cationic one, may be more relevant here, particularly when exerting antiviral activity against enveloped viruses.

Finally, drug combination studies revealed that Brilacidin exhibited a strong synergistic effect with remdesivir against HCoV-OC43 in cell culture.

"Human coronaviruses can cause severe acute respiratory syndrome, as well as contribute to a significant portion of upper and lower respiratory tract infections observed in humans worldwide," said Jun Wang, PhD, currently Associate Professor of Pharmacology and Toxicology in the College of Pharmacy at the University of Arizona. Dr. Wang will assume a new academic position, in January 2022, as Associate Professor in the Department of Medicinal Chemistry at Rutgers University's Ernest Mario School of Pharmacy. "Brilacidin was shown in our lab testing to inhibit different endemic human coronavirus strains, in addition to SARS-CoV-2 pseudovirus, by targeting viral proteins and host factors. Our work supports Brilacidin's therapeutic potential as a broad-spectrum inhibitor of coronaviruses."

"These encouraging data assembled in this scientific paper reinforce Brilacidin's antiviral properties, including a likely ability of Brilacidin to be less prone to developing resistance than other classes of antivirals. Brilacidin was shown to possess a dual-acting antiviral mechanism of action-able to target both virus and host. Also, the broad spectrum of activity against multiple coronaviruses indicates that Brilacidin remains active over a large variation in the sequence of viral proteins and encoding viral RNA," said William F. DeGrado, PhD, Professor in the Department of Pharmaceutical Chemistry at the University of California San Francisco and Scientific Advisor to the Company.

DeGrado continued: "I look forward to investigating Brilacidin further. Small molecule therapeutics with novel antiviral mechanisms of action will always be urgently needed. Given Brilacidin exerts antiviral activity prior to infection of cells, developing Brilacidin for potential prophylactic use by targeting the nasal passageway and lungs may be a particularly appealing clinical pathway."

In September, Dr. DeGrado gave the Spiers Memorial Lecture at the 2021 Faraday Discussion, where DeGrado's and peers' seminal work to discover Brilacidin was highlighted and later published.

About Brilacidin and COVID-19

Host Defense Peptides/Proteins (HDPs), and their mimetics such as Brilacidin, increasingly are being recognized for their therapeutic potential, including an ability to prevent and treat acute viral infections. Therapeutics, including small molecules with broad-spectrum activity that can inhibit key viral functions, such as cell entry, have been identified by the Biden administration for future government funding ($11.8 billion is proposed) to help prepare for and respond to future pandemics.

Brilacidin is the only non-peptidic HDP-mimetic drug candidate to be evaluated in a clinical trial as a treatment for SARS-CoV-2, the coronavirus responsible for COVID-19 (see NCT04784897). Innovation Pharmaceuticals is developing Brilacidin for the treatment of COVID-19 under FDA Fast Track designation. A dual-acting inhibitor able to target viral proteins and host factors, while also exhibiting robust anti-inflammatory and antibacterial properties, Brilacidin has shown potent and consistent inhibition in vitro against coronaviruses, alphaviruses and bunyaviruses (with lab testing against other viruses also underway), supporting Brilacidin's development as a broad-spectrum antiviral. The annual global antiviral drug market is estimated to reach $44 billion by 2026.

A peer-reviewed article in Viruses supporting Brilacidin's COVID-19 treatment potential can be accessed at the link below.

• Bakovic, A.; Risner, K.; Bhalla, N. (et al). Brilacidin Demonstrates Inhibition of SARS-CoV-2 in Cell Culture. Viruses 2021, 13, 271; https://doi.org/10.3390/v13020271
  https://www.mdpi.com/1999-4915/13/2/271/htm

Two independent Machine Learning studies identified Brilacidin as one of the most promising inhibitors of SARS-CoV-2, the virus responsible for COVID-19, based on Brilacidin's molecular properties. Click here to learn more.

For more details on the Company's Expanded Access policy, please visit:
https://www.ipharminc.com/expanded-access-and-compassionate-use

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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 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, without limitation, statements concerning future drug development plans, statements regarding the antiviral capabilities and therapeutic potential of Brilacidin and its potential impact on SARS-CoV-2 (COVID-19) and other viruses. 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 risks related to conducting pre-clinical studies and clinical trials and seeking regulatory and licensing approvals for Brilacidin and Kevetrin in the United States and other jurisdictions, including without limitation 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; prior test results may not be replicated in future studies and trials; 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; and the Company's licensee(s) may not successfully complete pre-clinical or clinical testing and the Company will not receive milestone payments. A more complete description of these and other risk factors is included in the Company's filings with the Securities and Exchange Commission. Many of these risks, uncertainties and assumptions are beyond the Company's ability to control or predict. You should not place undue reliance on any forward-looking statements. The forward-looking statements speak only as of the information currently available to the Company on the date they are made, and 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

SOURCE: Innovation Pharmaceuticals Inc.

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FAQ

What are the results of the Brilacidin Phase 2 COVID-19 trial conducted by Innovation Pharmaceuticals (IPIX)?

The results of the Phase 2 COVID-19 trial of Brilacidin are undergoing full data analysis to identify trends that may support its inclusion in larger government-sponsored trials.

What new findings were reported regarding Brilacidin and its antiviral properties?

Recent findings indicate that Brilacidin acts as a dual-acting broad-spectrum inhibitor, targeting both viral proteins and host factors, which suggests a lower likelihood of resistance development.

What are the next steps for Innovation Pharmaceuticals regarding Brilacidin?

The Company plans to submit Brilacidin for inclusion in larger clinical trials pending the results of their ongoing analysis, which may yield positive data.

How does Brilacidin compare to other antiviral drugs in terms of resistance?

Brilacidin may be less prone to developing resistance compared to other antiviral drugs due to its dual-targeting mechanism that affects both the virus and host factors.