BOTHELL, Wash. - Cocrystal Pharma, Inc. (NASDAQ: COCP), a clinical-stage biotechnology company, announced today the successful completion of a Phase 1 study's single-ascending dose (SAD) cohorts for its pan-viral protease inhibitor, CDI-988.
The study, conducted with healthy volunteers in Australia, demonstrated favorable safety and tolerability for the drug, which is being developed as a dual antiviral treatment for norovirus and coronaviruses.
In the trial, participants were administered CDI-988 in doses ranging from 100 mg to 600 mg. The results showed no serious adverse events or severe treatment-emergent adverse events, and no significant findings in laboratory assessments, physical exams, or electrocardiograms. All participants completed the study without any discontinuations.
Dr. Sam Lee, President and co-CEO of Cocrystal, expressed optimism about the drug's advancement, citing its "novel mechanism of action and superior broad-spectrum antiviral activity." The company is preparing for the next phase of the trial, the multiple-ascending dose (MAD) cohorts, with enrollment expected to begin in the fourth quarter of 2024.
CDI-988 has been designed to inhibit a highly conserved region in the active site of 3CL viral proteases, and it was developed using Cocrystal's proprietary structure-based drug discovery platform technology.
There are currently no approved antiviral treatments or vaccines for norovirus, which is responsible for an estimated 21 million cases of acute gastroenteritis annually in the U.S. alone, according to the CDC. The NIH estimates the annual burden of noroviruses to the U.S. at $10.6 billion.
The press release also highlighted the public health challenge posed by coronaviruses, including COVID-19 and its variants, which can range from asymptomatic cases to severe illness and death.
Cocrystal Pharma focuses on discovering and developing novel antiviral therapeutics that target the replication process of influenza viruses, coronaviruses, noroviruses, and hepatitis C viruses. The company's approach involves employing unique structure-based technologies and Nobel Prize-winning expertise.
The information presented is based on a press release statement from Cocrystal Pharma, Inc. and does not include speculative statements or endorsements of the drug's efficacy beyond the reported trial results.
In other recent news, Cocrystal Pharma made significant changes to its capital structure. The pharmaceutical company's stockholders approved a reduction in the number of authorized shares of capital stock, bringing it down from 155 million to 101 million shares. This decision was made during the company's 2024 Annual Meeting of Stockholders and became effective immediately upon filing the amendment to the Certificate of Incorporation.
In the same meeting, stockholders elected six directors to the company's Board, ratified Weinberg & Company as the independent registered public accounting firm, and approved the executive compensation package.
In other developments, Noble Capital maintained its Outperform rating on Cocrystal Pharma, with a steady price target of $10.00. This optimism is tied to anticipated results from the CC-42344 Influenza Virus Program.
The Phase 2a human-challenge study for this program recently completed enrollment, and results are expected in the second half of 2024. The company also anticipates filing for the Investigational New Drug (IND) for the forthcoming Phase 2b trials in the latter half of 2024. These are key junctures in the development process of Cocrystal Pharma's antiviral therapeutics.
InvestingPro Insights
As Cocrystal Pharma, Inc. (NASDAQ: COCP) advances its promising antiviral candidate CDI-988, investors are closely monitoring the company's financial health and market performance. According to the latest data from InvestingPro, COCP holds a market capitalization of approximately $22.99 million USD.
The company's financials show that it is not currently profitable, with a reported operating income of -20.21 million USD for the last twelve months as of Q1 2024. This aligns with an InvestingPro Tip indicating that analysts do not expect the company to be profitable this year.
Despite the challenges in profitability, Cocrystal Pharma's stock has shown resilience in the market, with a robust 51.17% price total return over the last three months and a 43.95% return over the last six months. This suggests investor confidence which may be bolstered by the company's strong cash position, as another InvestingPro Tip highlights that COCP holds more cash than debt on its balance sheet, providing a cushion for its ongoing research and development expenses.
For investors seeking a deeper dive into Cocrystal Pharma's financials and future prospects, InvestingPro offers additional insights. There are currently 9 more InvestingPro Tips available, which could help investors make more informed decisions.
To access these tips and a comprehensive analysis, visit InvestingPro's dedicated page for COCP. Remember to use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription, providing valuable savings on a tool that could be instrumental in your investment strategy.
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