Biotechnology company Cidara Therapeutics, Inc. (CDTX) announced Thursday that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for CD388 for prevention of influenza A and B in adults and adolescents who are at higher risk of influenza complications due to underlying immunodeficiency, are at higher risk of severe influenza despite influenza vaccination, or those for whom vaccines are contraindicated.
"This Breakthrough Therapy designation, in addition to the previously awarded Fast Track designation, underscores the importance of CD388 as a potential new non-vaccine prophylactic for seasonal influenza," said Jeffrey Stein, president and chief executive officer of Cidara.
The Breakthrough Therapy designation is based on positive results from the Phase 2b NAVIGATE trial in which CD388 provided statistically significant prevention of seasonal influenza in healthy unvaccinated adults aged 18-64.
A Phase 3 trial to evaluate the safety and efficacy of CD388, the ANCHOR Trial, was initiated at the end of September, six months ahead of schedule, in populations at high-risk for complications of influenza.
Based on feedback from the FDA, the study population has been expanded to include generally healthy adults over 65 years old with no specific co-morbidities in addition to other high-risk populations with certain comorbidities and immune compromised status.
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