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Universal Flu Antiviral Launches Phase 2a Study

September 15, 2022 • 11:35 am CDT
by Luisella Planeta
(Precision Vaccinations)

California-based Cidara Therapeutics, Inc. recently announced the initiation of its Phase 2a trial to evaluate the pre-exposure prophylactic activity of CD388 against influenza viruses.

CD388 is a highly potent, long-acting antiviral designed to deliver universal prevention of seasonal and pandemic influenza.

The study is being conducted under an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. to develop and commercialize Cidara's Cloudbreak® drug-Fc conjugates (DFCs) to prevent seasonal and pandemic influenza.

"The initiation of this Phase 2a trial ... represents the first study in which CD388's prophylactic potential against influenza will be examined in humans," said Jeffrey Stein, Ph.D., president and CEO of Cidara, in a press release on September 13, 2022.

"Because of its mode of action, CD388 has the potential to enable universal influenza coverage against all viral strains for all people, including those with compromised immune systems."

The Phase 2a trial, which dosed its first healthy volunteer (of 168) on September 10, 2022, is a single-center, randomized, double-blind, placebo-controlled, proof-of-concept study to assess the prophylactic antiviral activity, safety, tolerability, and pharmacokinetics of CD388 against influenza via a human viral challenge (influenza) model, and to explore the impact of dose levels on efficacy.

While today's flu vaccines are credited with significant public health benefits and offer the best defense against infection, only about 48% of U.S. adults received a flu shot during the 2019–2020 influenza season.

Additional influenza vaccine news for the 2022-2023 flu season is posted at