Cidara Therapeutics, Inc. has announced that Janssen Pharmaceuticals, Inc. (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has delivered to Cidara its Election to Proceed Notice for CD388 (JNJ-0953) which is being developed for the universal prevention of influenza A and B. Responsibility for future development, manufacturing and commercialization activities of CD388 will be assumed by Janssen, which intends to transfer its rights and obligations under the agreement to another entity. As part of its exclusive worldwide collaboration with Janssen, Cidara is studying CD388 in Phase 1 (NCT05285137 and NCT05619536) and 2a (NCT05523089) clinical trials evaluating safety and pharmacokinetics as well as efficacy as pre-exposure prophylaxis against an influenza virus in healthy volunteers during a human challenge study. Earlier this year, Cidara announced promising interim efficacy and safety data from the Phase 2a study.

The interim analysis demonstrated that a single dose of CD388 decreased viral replication in the upper respiratory tract and lowered influenza incidence rate compared to placebo. As of the interim analysis, treatment with CD388 was generally well-tolerated, with no treatment emergent adverse events leading to study discontinuation or serious adverse events reported. Cidara continues to work in collaboration with Janssen to complete the Phase 1 and Phase 2a trials and will be reimbursed for all ongoing development activities by Janssen as provided in the Janssen Collaboration Agreement.

The complete CD388 Phase 2a data package is currently anticipated to be delivered to Janssen later this year. Cidara will receive a $7 million milestone payment from Janssen for the election to proceed for CD388 and other influenza DFCs. Under the collaboration agreement, Cidara is eligible to potentially receive an additional $685 million in development, regulatory and commercial milestones, plus tiered royalties on worldwide sales.