US-based Cidara Therapeutics will continue developing its CD388 programme for the prevention of influenza A and B in two Phase I (NCT05285137 and NCT05619536) and one Phase IIa (NCT05523089) trials.
The CD388 programme is part of Cidara’s licensing deal with Janssen, which includes reimbursements for clinical development.
CD388 received a fast track designation from the US Food and Drug Administration (FDA) in June 2023.
Cidara reported that its deal with Janssen is still in effect despite Janssen’s announcement to discontinue the internal development of much of its infectious disease pipeline, including JNJ-0953 (CD388). Adding that Janssen is required to notify Cidara of its intention to proceed with the CD388’s development within 90 days of receiving the Phase IIa data package.
If Janssen issues a formal Election to Proceed during the 90 days, then Janssen is responsible for development and commercialisation. Should Janssen fail to do so, then Cidara would have the right to terminate the agreement and retain the CD388 programme, including all Janssen-funded data and materials.
Cidara is confident in its product, with its CEO Jeffrey Stein stating in a press release: “Based on the positive interim Phase IIa data, the competitive landscape and substantial market opportunity, we remain excited for the significant potential of CD388 in the prevention of influenza A and B, whether we or another party further advances this promising asset.”
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Cidara’s antifungal treatment Rezzayo (rezafungin for injection) was approved by the FDA, leading to a $20m milestone-based licensing payment from Melinta Therapeutics. Other drug-Fc conjugates in Cidara’s pipeline such as CD388 are currently in pre-clinical development.