Cidara Therapeutics (CDTX) announced that the U.S. Patent and Trademark Office issued U.S. Patent No. 11,510,992, entitled Compositions and Methods for the Treatment of Viral Infections, for CD388, a highly potent, long-acting drug-Fc conjugate, DFC, designed to achieve universal prevention of seasonal and pandemic influenza. The patent is the first issued for CD388, and includes claims directed to the composition of matter of CD388. The patent is projected to expire in 2039 plus any available patent term extension. "We are pleased to receive the first U.S. patent for our lead flu DFC, CD388, as we establish robust IP protection for this new class of drug," said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. "Achieving this milestone concludes a productive year for the CD388 program, including the ongoing Phase 1 first in human trial, as well as the Phase 2a human challenge study. We look forward to announcing results from these trials in the first half of 2023." The Phase 1 study is a randomized, double-blind, dose-escalation study to determine the safety, tolerability and pharmacokinetics of intramuscular and subcutaneous administration of CD388 in healthy subjects. The Phase 2a trial is a study to assess the prophylactic antiviral activity, safety, tolerability and pharmacokinetics of CD388 against influenza via a human viral challenge model, and to explore the impact of dose levels on efficacy. Both trials are being conducted under an exclusive worldwide license and collaboration agreement with Janssen (JNJ).
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