Cidara to Present on Innovative CD388 at 2024 OPTIONS XII Influenza Conference

SAN DIEGO, Sept. 25, 2024 – Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology firm leveraging its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies aimed at treating severe diseases, announced it will present two studies at the OPTIONS XII for the Control of Influenza conference. The conference is scheduled from September 29 to October 2, 2024, in Brisbane, Australia. The presentations, one oral and one poster, will showcase safety and pharmacokinetic (PK) data from clinical trials of CD388, Cidara’s influenza drug-Fc conjugate candidate.

“We are excited to present at the OPTIONS XII conference and share the clinical data on CD388, our universally active influenza preventative,” stated Jeffrey Stein, Ph.D., president and CEO of Cidara. “These findings underscore the safety of CD388 across various doses and administration methods. Additionally, the pharmacokinetic data indicate the potential of CD388 to offer season-long protection against influenza A and B in both immune compromised and immune competent populations.”

The oral presentation, titled "Safety Data from Phase 1 and Phase 2a Studies of CD388, a Drug Fc-conjugate for Seasonal Pan-Influenza Prophylaxis", will be delivered by Taylor Sandison, MD, MPH, Chief Medical Officer of Cidara Therapeutics, on Tuesday, October 1, 2024, from 15:51–16:04 AEST. This presentation will cover safety data from three clinical trials involving 108 participants monitored for approximately 5-14 months. No dose-, route-, or repeat-dose-related treatment-emergent adverse events (TEAEs) were observed. Overall, CD388 was safe and well-tolerated when administered via subcutaneous or intramuscular injection in all three studies. These results support further clinical trials of CD388 for single-dose seasonal influenza prevention.

The poster presentation, titled "Pharmacokinetics and Safety of CD388 Following Subcutaneous Administration in Healthy Japanese Participants", will also be presented by Taylor Sandison, MD, MPH, on Sunday, September 29, from 18:30-20:30 AEST. This poster will summarize PK and safety data from a study involving 27 healthy Japanese volunteers who received a single subcutaneous dose of CD388 (50, 150, or 450 mg) or a placebo. The PK parameters showed low-to-moderate variability across all dose levels and were consistent with previous Phase 1 results in Western participants. Safety observations were similar across all study groups, with no clinically significant TEAEs reported. These findings support further clinical trials of CD388 in the Japanese population for seasonal influenza prevention.

CD388 is an investigational drug-Fc conjugate comprising multiple copies of a potent neuraminidase inhibitor attached to a proprietary Fc fragment of a human antibody. Unlike vaccines or monoclonal antibodies, DFCs are low molecular weight biologics designed to act as long-acting small molecule inhibitors. CD388 aims to offer universal protection against all known strains of seasonal and pandemic influenza with the potential for season-long protection via a single subcutaneous or intramuscular dose. As CD388 does not rely on an immune response, it is expected to be effective regardless of the individual's immune status.

Cidara Therapeutics utilizes its Cloudbreak® platform to develop novel drug-Fc conjugates, combining targeted small molecules or peptides with a proprietary human antibody fragment (Fc). The lead candidate, CD388, is a long-acting antiviral intended to provide universal influenza prevention with a single dose. CD388 received Fast Track Designation from the U.S. Food and Drug Administration (FDA) in June 2023, and Cidara plans to initiate a Phase 2b trial during the 2024 Northern Hemisphere influenza season. Additionally, the company is developing other DFCs for oncology, with CBO421, targeting CD73 in solid tumors, having received IND clearance in July 2024. Cidara Therapeutics is based in San Diego, California.