Cidara Shares Surge As CD388 Phase 2b Trial In Seasonal Influenza Meets All Endpoints

(RTTNews) - Shares of Cidara Therapeutics, Inc. (CDTX) were surging around 86 percent in the pre-market activity on the Nasdaq, after the biotechnology company announced Monday positive topline results from its Phase 2b NAVIGATE trial evaluating CD388 for the prevention of seasonal influenza in healthy unvaccinated adults aged 18 to 64.

The study met its primary and all secondary efficacy endpoints for all dose groups. The company has submitted end of Phase 2 meeting request to the U.S. Food and Drug Administration to review the results and further discuss the Phase 3 trial design and start time.

The company, which applies its proprietary Cloudbreakplatform to develop drug-Fc conjugate (DFC) therapeutics, noted that the randomized, double-blind, placebo-controlled trial met its primary endpoint. The trial demonstrated a statistically significant prevention efficacy or PE for each of three dose groups in individuals who received a single dose of CD388 at the beginning of the flu season and were evaluated for laboratory and clinically confirmed influenza over 24 weeks.

In addition, the trial met all secondary endpoints, including efficacy at 37.8 and 37.2 degree Celsius temperature thresholds, as well as maintenance of PE up to 28 weeks with statistical significance.

Over the same period, CD388 was well-tolerated at all doses with no unexpected dose-limiting treatment-emergent adverse events observed.

The company added that safety and tolerability data were similar in all arms with no safety signals observed.

In addition, no drug-related serious adverse events were observed, and treatment-emergent adverse events showed no dose-dependent pattern between CD388 and placebo groups. In the trial, injection site reaction rates were similar across all CD388 dose groups and placebo.

Cidara said it expects to present additional results from the NAVIGATE trial at upcoming scientific conferences in 2025.

Jeffrey Stein, president and chief executive officer of Cidara, noted that CD388, as a long-acting antiviral drug, was designed to provide once per season protection against all strains of influenza in all people, irrespective of immune status.

Nicole Davarpanah, chief medical officer of Cidara added, "The statistically significant and clinically meaningful results shown with CD388 mark a potential breakthrough for patients and the future of influenza prevention. These Phase 2b results support the potential of CD388 to be a highly effective and well-tolerated seasonal prophylactic for high-risk individuals, such as those with compromised immune systems or those at a heightened risk of severe illness due to underlying health conditions. We look forward to engaging with the FDA and expanding on these results in our planned Phase 3 trial."

In pre-market activity on the Nasdaq, Cidara shares were trading at $39, up 85.54%.

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