Cidara Therapeutics Announces Issuance of First U.S. Patent for CD388
SAN DIEGO, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (NASDAQ: CDTX), a biotechnology company developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases, today 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 (NCT05285137) 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 (NCT05523089) 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 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.
CD388 is a DFC from Cidara’s Cloudbreak® platform, which stably couples highly potent small molecules or peptides to a proprietary composition of a human antibody fragment (Fc). For influenza, CD388 is designed to directly inhibit viral proliferation by targeting a conserved region on the viral envelope, potentially conferring universal prevention of Types A and B influenza with a single seasonal dose.
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