Cidara Therapeutics Announces Completion of Dosing the First Cohort of Healthy Volunteers in Phase 1 Trial

Cidara Therapeutics, Inc. recently announced the first cohort of healthy volunteers has been dosed in its Phase 1 trial of CD388, a highly potent long-acting antiviral immunotherapy designed to deliver universal prevention of seasonal and pandemic influenza. The study is being conducted under an exclusive worldwide license and collaboration agreement with Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical companies of Johnson & Johnson, to develop and commercialize Cidara’s Cloudbreak drug-Fc conjugates (DFCs) for the prevention and treatment of seasonal and pandemic influenza.

The Phase 1 trial (NCT05285137), which dosed its first healthy volunteer in mid-March, 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. To date, dosing of the first, low-dose cohort has been completed and the next mid-dose cohort is advancing as planned.

“Initiating the first human study of a long-acting DFC is a tremendous milestone for Cidara and our Cloudbreak platform. It is also a testament to our team’s firm commitment to transforming universal viral protection for all,” said Jeffrey Stein, PhD, President and Chief Executive Officer of Cidara. “Based on its compelling profile, CD388 has the potential to address a critical unmet need for universal prevention and the treatment of seasonal and pandemic influenza, especially for those who remain insufficiently protected by current flu vaccines, such as patients with compromised immune systems or patients at high risk for severe complications. We are excited to continue advancing CD388 through the clinic with our collaborator, Janssen.”

Cidara’s Cloudbreak DFCs, which stably couple a highly potent small molecule or peptide to a proprietary variant of a human antibody fragment (Fc), is a fundamentally novel approach to treat and prevent serious viral infections and cancers. For influenza, the long-acting, CD388 DFC is designed to directly inhibit viral proliferation by targeting a conserved region on the viral surface, potentially conferring universal prevention and treatment of Types A and B influenza with a single seasonal dose.

Cidara is developing a new generation of immunotherapeutic antivirals from its Cloudbreak platform that couple potent antivirals to a human antibody fragment (Fc). These highly potent, long-acting, drug-Fc conjugates (DFCs) directly inhibit viral proliferation while simultaneously engaging the immune system. In addition to the clinical-stage CD388 program for seasonal and pandemic influenza, Cidara is advancing DFC programs to target other life-threatening viruses, such as RSV, HIV, and SARS-CoV-2, as well as immuno-oncology targets associated with multiple cancers.

Cidara is developing long-acting therapeutics designed to improve the standard of care for patients facing serious diseases. The company’s portfolio is composed of new approaches aimed at transforming existing prevention and treatment paradigms, first with its lead Phase 3 antifungal candidate, rezafungin, in addition to drug-Fc conjugates (DFCs) targeting viral and oncology diseases from Cidara’s proprietary Cloudbreak platform. Cidara is headquartered in San Diego, CA. For more information, please visit www.cidara.com.