Bellerophon Therapeutics Inc (NASDAQ:BLPH) has acquired nod from the U.S. FDA of the Agency’s support of all modifications suggested by the firm to its Phase III program for INOpulse in PAH.
Under the recently modified Phase III plan, the current 1-year INOvation-1 study, and a subsequent positive randomized withdrawal trial with almost 40 subjects who will be crossing at the top of the INOvation-1 trial, can serve as the adequate trials to support a NDA proposal for INOpulse in PAH subjects on LTOT.
The randomized withdrawal trial and INOvation-1 are intended to be carried out on near corresponding timelines, which could cut the time to market for lead candidate INOpulse in PAH by almost two years.
Both studies will include an interim analysis that will be done almost half-way through trial. It can be closed in this year for the INOvation-1 trial, however for the withdrawal trial it can extend to 2H2018. The interim analysis is a means to halt the studies in case the primary endpoints are achieved earlier than planned. The original Phase III plan had two trials in the scope.
Depending on these parameters, Bellerophon Therapeutics believes that INOpulse is all set to achieve regulatory nod in 2022. With the allowed changes to the Phase III plan, the INOvation-2 trial will be swapped with the randomized withdrawal study. It should be noted that it is a much smaller trial that would be carried out in almost 40 subjects over a 4-month period and two-month randomized withdrawal. The company reported that under this modified clinical study protocol, the regulatory nod for INOpulse could come as early as 2020.
Fabian Tenenbaum, who is the CEO of Bellerophon Therapeutics, reported that they are satisfied that the FDA has decided with the proposed changes to their PAH Phase 3 plan, which can make INOpulse reachable to PAH patients virtually 2 years earlier than the original reported period of Phase 3 program. The modification of Phase 3 plan will substantially reduce company’s clinical development costs.