FDA fast tracks novel drug conjugate for prevention of influenza A and B infection in adults

Seasonal influenza, an acute respiratory infection caused by influenza viruses is a year-round disease burden. It causes illnesses that range in severity and sometimes lead to hospitalization and death its management is a leading concern.

Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company known for developing long-acting therapeutics designed to save lives and improve the standard of care for patients facing serious diseases. The company has been successful in treating influenza.

On 23rd June the company announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CD388, Cidara’s novel drug-Fc conjugate (DFC) candidate. CD388 is being developed in collaboration with Janssen Pharmaceuticals for the prevention of influenza A and B infection in adults who are at high risk of severe influenza, including those for whom vaccines are either ineffective or contraindicated.

Fast Track designation aimed to facilitate the development and expedite the review of drugs to treat serious conditions with unmet medical needs. Cidara recently announced promising interim efficacy and safety data from the ongoing Phase 2a study, being conducted in collaboration with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, that is evaluating the pre-exposure prophylactic activity of CD388 against the H3N2 influenza A virus strain.

Looking Forward statements related to whether the ongoing Phase 2a study of CD388 might produce data consistent with the interim analysis, whether Cidara or Janssen will conduct the additional studies required to complete clinical development of CD388, and whether additional studies will ultimately generate the data necessary to demonstrate the safety and efficacy of CD388 are limited.

Such statements however are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s preclinical or clinical trials, delays in action by regulatory authorities due to limitations on inspections and other COVID-19-related effects, and impacts of the COVID-19 pandemic or other obstacles on the enrollment of patients or other aspects of CD388 development.

Reference: https://www.cidara.com/news/cidara-therapeutics-receives-u-s-fda-fast-track-designation-for-cd388-a-novel-drug-fc-conjugate-targeting-influenza-a-and-b/.