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Island Pharmaceuticals initiates dosing of Phase2a patients in ISLA-101 dengue fever trial

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By Imelda Cotton - 
Island Pharmaceuticals ASX ILA ISLA-101 PROTECT clinical trial
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Antiviral drug development company Island Pharmaceuticals (ASX: ILA) has initiated the dosing of all subjects in the Phase 2a component of its ISLA-101 Phase 2a/b PROTECT clinical trial to treat dengue fever.

The trial capitalises on years of research by the US Army to develop a live attenuated strain of the dengue virus, which can be used to examine dengue infection in a highly-controlled setting.

The strain (or challenge) virus caused a mild but clinically relevant dengue infection in 14 enrolled subjects prior to treatment with ISLA-101.

Potential countermeasure

The Phase 2a/b trial includes a prophylactic (preventative) and therapeutic arm for the first time as a potential countermeasure to combat the dengue virus.

Dengue – for which there is currently no treatment option – affects more than 400 million individuals a year.

Data from the Phase 2a prophylactic portion are expected before year-end and Island expects to commence the Phase 2b therapeutic arm in the new year.

Pivotal moment

Managing director Dr David Foster said the PROTECT clinical trial was a pivotal moment for Island.

“We are the first company in the world to investigate an agent as both a prophylactic and therapeutic against dengue in a clinical setting with a challenge virus and we are weeks away from understanding the potential impact of our drug ISLA-101 on dengue fever,” he said.

“We are proud to be conducting this innovative trial to find a prevention or treatment for this devastating virus at a time when infection rates are growing rapidly around the globe.”

Trial funding

Island has secured approximately $3.5 million in new funding to complete the ISLA-101 Phase 2a/b trial.

The capital raising will be conducted via a two-tranche placement to existing and new investors priced at $0.07 per share, representing a discount of 11.39% to the 15-day volume-weighted average price at 30 September.

One new option will be attached at the same price to every new share issued, with 50% of options expiring within 12 months of issue and the remainder expiring within 24 months.

Proceeds from the placement will also be used to advance a due diligence program for antiviral molecule galidesivir.

Investor support

Cornerstone supporters of the placement – which was managed directly by Island – include biotech investor Dr Daniel Tillett, prominent Hong Kong-based fund manager Angus Walker, Island co-founder and major investor Dr Bill Garner, substantial shareholder Jason Carroll and recently appointed non-executive director Chris Ntoumenopolous.

“This fundraising is an outstanding outcome for Island and we are delighted to receive strong support from investors who see the potential in our work,” Dr Foster said.

“We are now funded for our current programs, which will take us through several important inflection points including all data readouts on the Phase 2a/b trial.”