BOTHELL, Wash. - Cocrystal Pharma, Inc. (NASDAQ:COCP), a clinical-stage biotechnology company trading near its 52-week high of $3.26, has announced the extension of its Phase 2a human challenge study of the investigational influenza drug CDI-42344 due to lower than expected influenza infection rates among participants. The company's stock has shown remarkable momentum, delivering an 89% return year-to-date according to InvestingPro data. The study, which began in December 2023, is designed to assess the safety, tolerability, and antiviral activity of CC-42344, a broad-spectrum oral inhibitor targeting the influenza PB2 protein.
The decision to extend enrollment comes after the realization that the H3N2 viral strain used to challenge study participants did not result in the anticipated infection rates, rendering virology results uninterpretable. While the company had previously reported successful enrollment of 78 subjects by May 2024 and favorable safety outcomes, with no serious adverse events or drug-related discontinuations, InvestingPro analysis indicates the company is quickly burning through cash, with a current ratio of 7.32 maintaining operations.
Dr. Sam Lee, President and co-CEO of Cocrystal, expressed disappointment in the low infectivity but remains optimistic about the drug candidate's potential due to its unique mechanism of action and high barrier to developing resistance. The company is now preparing a protocol amendment for approval by the United Kingdom (TADAWUL:4280) Medicines and Healthcare Products Regulatory Agency (MHRA) to ensure adequate infection rates in the extended study.
CC-42344, which was discovered using Cocrystal's proprietary structure-based drug discovery platform, has demonstrated promising in vitro antiviral activity against various influenza A strains, including those resistant to other antiviral drugs like Tamiflu® and Xofluza®.
Influenza remains a significant global health concern, with an estimated 1 billion cases annually and up to 650,000 deaths. The potential emergence of highly pathogenic avian influenza viruses and resistance to existing antivirals underscores the urgent need for new treatments.
Cocrystal Pharma focuses on developing novel antivirals for influenza, coronaviruses, noroviruses, and hepatitis C. The extension of the Phase 2a study aims to provide the necessary data to advance CC-42344 as a potential treatment option for pandemic and seasonal influenza A infections. With analyst price targets ranging from $7 to $10, significantly above current trading levels, investors seeking deeper insights into Cocrystal's potential can access 15 additional exclusive ProTips and comprehensive financial analysis through InvestingPro's advanced platform.
This information is based on a press release statement from Cocrystal Pharma, Inc.
In other recent news, Cocrystal Pharma has reported significant changes to its executives' compensation packages, including salary increases, bonuses, and restricted stock unit (RSU) grants. The base salaries of Co-Chief Executive Officers James Martin and Dr. Sam Lee were increased from $400,000 to $416,000, accompanied by a bonus of $200,000 and a grant of 40,000 RSUs each. The Board also approved cash stipends and RSU grants for its non-employee directors, contingent on their continued service to the company.
In more recent developments, Cocrystal Pharma has initiated the multiple-ascending dose (MAD) phase of their Phase 1 clinical trial for CDI-988, a broad-spectrum oral pan-viral protease inhibitor. This follows a successful single-ascending dose phase completed earlier. Topline results from the MAD portion of the CDI-988 study are anticipated in late 2024 or early 2025.
Additionally, Cocrystal Pharma has announced a significant change in its capital structure, reducing the number of authorized capital stock from 155 million to 101 million shares. On the analyst front, H.C. Wainwright has maintained a neutral rating on Cocrystal Pharma, revising its price target to $7.00. Simultaneously, Noble Capital has retained its Outperform rating on the company, expressing positive expectations for the CC-42344 Influenza Virus Program.
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