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Island Pharma (ASX:ILA) has reported seeing a “reduction in viral load” in those patients with dengue treated with its ISLA-101 drug. (Though, worth noting, the Phase 2a section has only four participants.)
There were also no safety concerns associated with dosing that require further examination by a relevant committee, the company stated on Wednesday – greenlighting the company’s path to test the Phase 2b cohort of the study.
The U.S. based study – in which participants are deliberately infected by a strain of dengue fever, apparently, developed by the U.S. Military – is likely to proceed to that second cohort in January next year, once the company deals with the FDA.
“In contrast to dengue caused by the bite of an infected mosquito, which can be quite variable and unpredictable, the goal of a challenge study is to use a model virus that provides a reproducible infection,” the company wrote of its trial on Wednesday.
Using oral gel capsules, the ISLA-101 study will monitor patients affected with dengue for 90 days after transmission. The phase 2a portion of the study saw three of four participants dosed for 21 days with the fourth given a placebo.
Island on Wednesday reported Phase 2a patients had expected levels of ISLA-101 in their blood and were not exceeding those predicted levels.
Phase 2b is set to be a randomised therapeutic trial involving 10 participants with dengue to be transmitted and ISLA-101 treatment starting on day eight, one week later.
“With the support of the recent $3.5m placement, the Phase 2b trial remains fully funded and Island is well positioned to pursue its additional pipeline targets,” Island CEO Dr. David Foster said.
“While we are blinded to the full dataset, the unblinded Safety Review Committee has clearly and unanimously stated there were no safety issues with ISLA-101 and also that the drug showed evidence of anti-dengue virus activity.”
ILA last traded at 16.5cps.
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