SAN DIEGO, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak® platform to develop drug-Fc conjugate (DFC) immunotherapies designed to save lives and improve the standard of care for patients facing serious diseases, today announced two presentations at OPTIONS XII for the Control of Influenza conference, to be held September 29 through October 2, 2024 in Brisbane, Australia. The presentations, one oral and one poster, will highlight safety and pharmacokinetic (PK) data from clinical studies of CD388, Cidara’s influenza drug-Fc conjugate (DFC) candidate.
“We are pleased to have the opportunity to present at this year’s OPTIONS XII conference and share the clinical data on our universally active influenza preventative, CD388,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “These data support the safety of CD388 administered over a range of doses via multiple routes of administration. Moreover, the pharmacokinetic data support the potential use of CD388 in immune compromised as well as immune competent populations to provide season-long protection against influenza A and B.”
Oral Presentation
Title: Safety Data from Phase 1 and Phase 2a Studies of CD388, a Drug Fc-conjugate for Seasonal Pan-Influenza Prophylaxis
Presenter: Taylor Sandison, MD, MPH, Chief Medical Officer, Cidara Therapeutics
Date/Time: Tuesday, October 1, 2024, 15:51–16:04 AEST
This presentation summarizes the safety data from three CD388 clinical trials that involved 108 subjects who were followed for approximately 5–14 months. There were no dose-, route- or repeat-dose-related treatment-emergent adverse events (TEAEs). Overall, CD388 administered via subcutaneous or intramuscular injection was safe and well-tolerated in all three clinical trials. These data support further clinical studies with CD388 for single-dose prevention of seasonal influenza.
Poster Presentation
Title: Pharmacokinetics and Safety of CD388 Following Subcutaneous Administration in Healthy Japanese Participants
Presenter: Taylor Sandison, MD, MPH, Chief Medical Officer, Cidara Therapeutics
Date/Time: Sunday, September 29, 18:30-20:30 AEST
This presentation summarizes the pharmacokinetics (PK) and safety data of 27 healthy volunteers of Japanese descent dosed subcutaneously with a single dose of CD388 (50, 150, or 450 mg) or placebo. Overall PK parameters showed low-to-moderate variability across all doses and were similar to results from a previous Phase 1 clinical study in Western participants. Safety observations were comparable across the study arms. There were no clinically significant treatment-emergent adverse events (TEAE). These data support further clinical studies with CD388 in the Japanese population for prevention of seasonal influenza.
AboutCD388
CD388 is an investigational drug-Fc conjugate (DFC) comprised of multiple copies of a potent small molecule neuraminidase inhibitor stably conjugated to a proprietary Fc fragment of a human antibody. DFCs are not vaccines or monoclonal antibodies but are low molecular weight biologics which are designed to function as long-acting small molecule inhibitors. CD388 was designed to provide universal protection against all known strains of seasonal and pandemic influenza with the potential to provide season-long protection with a single subcutaneous or intramuscular administration. Importantly, because CD388 is not a vaccine, its activity is not reliant on an immune response and thereby is expected to be efficacious in individuals regardless of immune status. More information can be found at: https://www.cidara.com/cloudbreak/influenza/.
About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak® platform to develop novel drug-Fc conjugates (DFCs) comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment (Fc). Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA), and the Company plans to advance CD388 into a Phase 2b trial in the 2024 Northern Hemisphere influenza season. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which will be developed to target CD73 in solid tumors. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “may,” “believe,” “plan,” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to plans and timing for initiating a Phase 2b clinical trial for CD388 and whether the safety and pharmacokinetic data observed in clinical trials to date will be confirmed with larger studies in different patient populations. Such statements 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, unanticipated impacts of the workforce reduction, difficulties in obtaining potential partners or other obstacles to clinical development. These and other risks are identified under the caption “Risk Factors” in Cidara’s most recent Quarterly Report on Form 10-Q and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.
INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
britchie@lifesciadvisors.com
MEDIA CONTACT:
Michael Fitzhugh
LifeSci Communications
mfitzhugh@lifescicomms.com
