A recent journal article in the publication Viruses, as summarized in News Medical, discusses the potential of antimicrobial peptides—and their mimics, like Brilacidin—for treatment of COVID-19. Another News Medical article, accessible here, similarly highlights defensins as promising SARS-CoV-2 agents.
With our Phase 2 clinical trial of Brilacidin for COVID-19 now fully enrolled, the Company looks forward to unblinding study data and releasing topline results, as reported in our last press release.
Patient data is being compiled through Day 60, per FDA guidance (pdf) (see page 11), as it is considered an acceptable time-frame to assess longer-term outcomes in COVID-19 studies, particularly for critically-ill patients.
News Medical
Viruses
Tonk, M.; Růžek, D.; Vilcinskas, A. Compelling Evidence for the Activity of Antiviral Peptides against SARS-CoV-2. Viruses 2021, 13, 912. https://doi.org/10.3390/v1305091
https://www.mdpi.com/1999-4915/13/5/912/htm
“In this opinion article, we have highlighted the potential of AMPs as candidate antiviral drugs or drug leads. AMPs can be produced rapidly by chemical synthesis or the expression of recombinant peptides, and can be modified to improve their efficacy and stability in vivo. AMPs could therefore be used in the fight against COVID-19 and future viral pandemics either as new first-line treatments or as adjuncts to existing antiviral drugs.”
Forward-Looking Statements: This shareholder alert 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, 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 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.