Island Pharmaceuticals is pleased to share that the US Food and Drug Administration (FDA) has cleared the proposed protocol amendments for its Phase 2a/b clinical trial for ISLA-101, Island’s lead drug candidate, in dengue fever.
Using a human challenge study model, the Phase 2a/b trial will explore both prophylactic (prevention) and therapeutic arm split across two cohorts, and has been renamed PROTECT (PROphylactic and TrEatment Challenge Trial). As part of the consultation process on the protocol, the FDA requested that Island wait to start infecting subjects until the end of mosquito season, which occurs on October 1.
Following FDA advice, Island plans to start dosing the Phase 2a (prophylactic) cohort in late September and start infecting around October 1, expecting full readout well before the end of the year. Phase 2b will begin being dosed in January 2025. ISLA-101 will be administered at a single dose level, twice daily across multiple days.
Island has received ethics approval from the Institutional Review Board (IRB) at SUNY Update New York; steps seeking IRB approval from the US Army are currently underway. Island is pleased to advise that the cost to Island for the full study is around US $1.08m, substantially lower than prior estimates in view of grant support as announced in May this year.
Island CEO and Managing Director Dr David Foster said: “We have worked hard to bolster our internal capabilities and as a result have not needed to engage a CRO for this study. This strategy not only has streamlined efforts on protocol revisions, FDA communications and trial execution, but has substantially reduced costs enabling us to complete the Phase 2a, prophylactic cohort of the PROTECT study with existing funds.”
For more details on the PROTECT Phase 2a/b clinical trial, read the full announcement via this link: https://lnkd.in/gFscYhqN
#mosquitobornedisease #denguefever #antiviraltherapeutics
Sr. Vice President, Modeling at Nova In Silico
9moSuper exciting news, Dr. Baiteng Zhao. Very happy for you (Hook 'em!) and for Dr. Tae Han and the rest of the Profound Bio team - and for cancer patients needing better therapies. Continued success!