Australian antiviral drug development company Island Pharmaceuticals Ltd has completed dosing for the Phase 2a component of its ISLA-101 Phase 2a/b clinical trial in dengue fever.
The study, known as PROTECT, is based on years of research by the US Army, using an attenuated strain of the dengue virus to simulate a mild but clinically significant infection in a controlled environment.
The trial investigates both preventative and therapeutic measures for dengue fever, a virus that affects over 400 million people annually and currently has no therapeutic treatments.
Phase 2a focuses on a prophylactic arm, involving four subjects (randomised 3:1 active-to-placebo). On October 4 this year, the trial's subjects will be administered the attenuated strain of dengue fever, with symptoms monitored for 90 days to track viremia and other key indicators. Phase 2b, which will include 10 subjects (randomised 8:2), will explore therapeutic options and is expected to begin in early 2025.
Data from the Phase 2a study is anticipated before the end of 2024.
Island CEO and managing director Dr David Foster said: “Dosing the Phase 2a subjects in this powerful Phase 2 PROTECT clinical trial is a pivotal moment for Island. We are weeks away from understanding the potential impact of our drug ISLA-101 on dengue fever.
"As the first company in the world to investigate an agent as both a prophylactic and therapeutic against dengue in a clinical setting with a challenging virus, we are proud to be conducting this innovative trial to find a preventative and/or treatment for this devastating virus, at a time when infection rates are rapidly growing around the globe.”
Raising $3.5 million
Island has secured firm commitments for a two-tranche placement aimed at raising around A$3.5 million at 7 cents (A$0.07) per share. The placement includes one new option for every share issued, with an exercise price of 7 cents (A$0.07). These options are set to expire 50% within 12 months and 50% within 24 months, subject to shareholder approval.
The placement is backed by investors who proactively approached the company, offering cornerstone support. Notable investors include biotech investor and Race Oncology Ltd (ASX:RAC, OTC:RAONF) CEO 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 newly appointed non-executive director Chris Ntoumenopolous (pending shareholder approval).
“This fundraising is an outstanding outcome for Island and places the company in a very strong position to complete the current Phase 2a/b study for ISLA-101. It also supports the due diligence campaign for the Galidesivir antiviral therapeutic program and provides the acquisition funding required, should we proceed with the potential acquisition," Foster said.
“We are delighted to receive extremely strong support from Dr Daniel Tillett and Angus Walker, who see the potential in our programs. We are also grateful to Bill Garner, Jason Carroll and Chris Ntoumenopolous for their participation in this placement.
"We are now funded on current programs, which takes us through several important inflection points, including all data readouts on our current ISLA-101 Phase 2a/b clinical trial.”
Commenting on his participation, Tillett said: “I have been invested in Island for many years and have been watching the company closely over that time. Island's impressive clinical progress with ISLA-101, along with the recent pipeline expansion into new antivirals, has created a compelling investment opportunity.
"The ability to leverage historical clinical data to advance overlooked antivirals in areas of great unmet need, combined with the potential value of acquiring two priority review vouchers upon approval, is highly attractive.
"I’m delighted to be able to further support Island and ensure that the company has the financial resources required to fast track the clinical development of their advanced clinical assets.”