Cidara Therapeutics (CDTX) shares experienced a remarkable surge of over 90% this past Monday, following the announcement of an impressive advancement in their universal flu vaccine development. The results from their mid-stage clinical trial demonstrated that the vaccine successfully achieved all its primary and secondary objectives in combating seasonal influenza. The stock rose after the company announced earlier in a press release that the company was applying its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) therapeutics, and today announced positive topline results from its randomized, double-blind, placebo-controlled 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 endpoint, demonstrating a statistically significant prevention efficacy (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. The study also 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.
“Results such as these are unprecedented in influenza and support our confidence in the potential of CD388 to offer robust, once-per-season protection against influenza A and B,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “As a long-acting antiviral drug, CD388 was designed to provide once per season protection against all strains of influenza in all people, irrespective of immune status. These results provide us with continued conviction in the remarkable opportunity CD388 presents to deliver broad influenza protection. We thank all of our collaborating partners for their dedication and hard work to reach this milestone. Cidara is grateful to the individuals whose participation helped us to generate these important results.”
About CD388
CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/.
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