Janssen Pharmaceuticals, Inc. has elected to proceed under its license agreement with Cidara Therapeutics 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.
 
Cidara will receive a $7 million milestone payment from Janssen for the election to proceed for CD388 and other influenza drug-Fc conjugate (DFCs). Under the collaboration agreement, Cidara is eligible to potentially receive an additional $685 million in development, regulatory and commercial milestones, plus royalties on worldwide sales.
 
As part of its exclusive worldwide collaboration with Janssen, Cidara is studying CD388 in Phase 1 and 2a clinical trials evaluating safety and pharmacokinetics as well as efficacy as pre-exposure prophylaxis against an influenza virus in healthy volunteers. 
 
Interim efficacy and safety data from the Phase 2a study demonstrated that a single dose of CD388 decreased viral replication in the upper respiratory tract and lowered influenza incidence rate compared to placebo. At interim analysis, 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. The complete CD388 Phase 2a data package is currently anticipated to be delivered to Janssen later this year.