SAN DIEGO, Oct. 16, 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 upcoming presentations at IDWeek 2024, to be held October 16–19, 2024 in Los Angeles, CA. The presentations will highlight clinical data on the safety, pharmacokinetics, and prophylactic activity of Cidara’s clinical-stage influenza DFC asset, CD388.
“We are pleased to share these clinical results at this year’s IDWeek, which underscore the potential for CD388 as an effective and well-tolerated DFC for single-dose, season-long prevention of influenza,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “We hope to share the results of our ongoing NAVIGATE Phase 2b clinical trial of CD388 at next year’s meeting.”
Oral Presentation
| Title: | CD388, a Novel Drug-Fc Conjugate (DFC), Demonstrates Prophylactic Activity in an Influenza Human Challenge Model |
| Presenter: | Taylor Sandison, MD, MPH, Cidara Therapeutics |
| Session: | Inhaling Insight: Advancements in Respiratory Viral Infections |
| Session Location: | 408A |
| Date/Time: | Saturday, October 19, 2:21–2:39 PM Pacific Time (PT) |
| Summary: | An analysis was conducted to determine prophylactic activity of CD388 against influenza disease in a Phase 2a human challenge study. The study found that a single subcutaneous dose of CD388 administered 5 days prior to influenza challenge was effective in preventing symptomatic disease among those who demonstrated seroconversion following influenza challenge. |
Poster and Rapid-Fire Presentation:
| Title: | Single-Dose and Repeat Single-Dose Ascending Dose Study Evaluating Safety, Tolerability, and Pharmacokinetics of Subcutaneous and Intramuscular CD388, a Novel Long-acting Drug-Fc Conjugate for Universal Prevention of Seasonal and Pandemic Influenza |
| Presenter: | Shawn Flanagan, Ph.D., Cidara Therapeutics |
| Session: | Novel Agents |
| Session Location: | Halls JK |
| Date/Time: | Friday, October 18, 2024, 12:15–1:30 PM (12:15 - 12:45 for rapid fire presentation) PT |
| Summary: | The safety, tolerability, and pharmacokinetics (PK) of CD388 were evaluated in healthy subjects administered either intramuscularly or subcutaneously with varying dosages of the drug. Absorption of CD388 was rapid both intramuscularly and subcutaneously, and elimination was slow, indicating that seasonal influenza prevention could be achieved with one dose per season. There was a lack of anti-drug antibody formation with repeat administration, supporting annual use of CD388, and no safety concerns were noted. |
About CD388
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 announced initiation of a Phase 2b trial in September 2024. Additional DFCs have been developed for oncology and in July 2024 Cidara received IND clearance for CBO421 which is intended 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
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