Island Pharmaceuticals to begin phase 2 trial for dengue prevention and treatment drug
pharmafile | January 5, 2023 | News story | Research and Development |
It is possible that Island Pharmaceuticals could begin its phase 2a PEACH clinical trial as soon as January 2023. The trial aims to assess its dengue prevention and treatment drug, ISLA-101.
The company is in the process of finalising its Investigational New Drug (IND) application to the FDA which will allow this trial to begin. The submission of this document is expected shortly, at which point the FDA will begin an ‘up to’ 30-day review of the application.
The PEACH trial will be a double-blind, randomised, and placebo-controlled study to assess the prophylactic examination of an antiviral in a dengue challenge model, which will be completed at SUNY Upstate University in New York, US. Island Pharmaceuticals has various trial partners, including the US Army, which should provide some level of validation for the programme.
The US Army Medical Research and Material Command (USAMRMC) has created a Dengue Human Infection Model (DHIM) in partnership with SUNY Upstate Medical University, which will be used in this trial in order to evaluate the efficacy of ISLA-101 to prevent and treat the dengue virus.
MST Access Research has commented: “We account for ISLA-101’s strong safety profile and lower risk disease target with a 25% probability of approval versus industry average of 15%. […] A 12-month forward valuation of $76.6m (previously $112m) reflects the current risk-averse sector investment trends. […] MST notes realisation of the valuation over the short term will be difficult but expects positive phase 2a results in H2CY23 to see a re-rating of the stock. The valuation is subject to usual upside/downside risks of drug development.”
Betsy Goodfellow
