Island Pharmaceuticals enjoys big quarter. Image: Getty.
Health & Biotech
Special Report: Island Pharmaceuticals CEO Dr David Foster has described Q1 FY25 as a “breakthrough” for the clinical stage biotech, which is focused on areas of unmet need for antiviral therapeutics to address infectious diseases.
During the quarter Foster said Island Pharmaceuticals (ASX:ILA) achieved several milestones including that it had signed a binding letter of intent with Nasdaq-listed BioCryst Pharmaceuticals for the potential acquisition of galidesivir.
The clinical-stage drug has shown strong antiviral activity against several viruses, including Ebola, Zika, and Marburg viruses.
In July ILA provided an update on its clinical program for ISLA-101 in dengue fever, including the filing of the final single ascending dose clinical study report with the US Food and Drug Administration (FDA), along with a proposed updated protocol for the Phase 2 clinical study.
In August, ILA confirmed that the US FDA had cleared the proposed amendment to the ISLA-101 Phase 2 clinical trial protocol, with the study structured as a Phase 2a/b to include a prophylactic and therapeutic arm split across two cohorts.
In late August 2024, Island started screening for enrolment of subjects for the ISLA-101 Phase 2a/b clinical study in dengue fever following Institutional Review Board (IRB) approval from the US Army.
Post quarter end in October ILA announced it had dosed all subjects in the Phase 2a prophylactic arm with data expected by the end of the calendar year.
ILA said all subjects now dosed and exposed to the challenge virus had been compliant, returning to the hospital for follow-up visits and blood draws.
After all subjects have completed taking the required dose of ISLA-101 or placebo, and the requisite number of blood samples have been collected, the samples will be sent to analytical labs.
The samples will be examined for several factors, including pharmacokinetics, RNAemia, viremia, immune cell profiling, and antibody response to the virus.
ILA said once the data from these analyses was obtained and compiled, a Safety Review Committee comprised of leading dengue experts would review the data and make a recommendation regarding how to proceed with the Phase 2b therapeutic arm.
In September ILA announced changes to its board including the appointment of Chris Ntoumenopoulos as non-executive director.
Dr David Brookes announced his retirement from the board to focus on other business activities.
In July, ILA executive chairman Dr Paul MacLeman presented to investors and industry at the 18th Bioshares Biotech Summit in Fremantle.
In September, the company was awarded the Rising Star 2024 Award by BioNTX as part of the 10th Annual iC³ Life Sciences & Healthcare Innovation Summit in Texas.
In the same month, MacLeman presented to investors at the Pitt Street Research Life Sciences Conference in Sydney.
Post-quarter, in October ILA announced the completion of a $3.5m two-tranche placement.
The new investment ensures ILA is well-funded, enabling the achievement of critical near-term inflection points and pipeline build.
Post-quarter, on October 8 ILA held a special investor webinar, where Foster provided an update on the Phase 2a/b PROTECT clinical trial and the recent placement.
CEO Dr David Foster said, “Q1 FY25 marked a breakthrough for Island.”
“After submitting our amended protocol to the US FDA for ISLA-101, we were able to commence a Phase 2a/b trial, incorporating both prophylactic and therapeutic arms across two cohorts,” he said.
“With the dosing of subjects and the administration of an attenuated strain of dengue in the Phase 2a prophylactic arm now complete, we eagerly await trial data and look forward to reporting further details later this quarter.”
Foster said the board welcomed Chris Ntoumenopoulos.
“In his short time with the company, Chris has proven to be a valuable asset, bringing fresh insights and a proactive approach that have positively influenced our direction and decision-making.”
“Additionally, the A$3.5m in new funding secured post-quarter has ensured we are in a strong financial position to deliver on our key clinical program inflection points and sharpen our focus on building Island’s asset pipeline, including the potential acquisition of galidesivir.”
ILA closed the quarter with a cash position of $720k.
This article was developed in collaboration with Island Pharmaceuticals, a Stockhead advertiser at the time of publishing.
This article does not constitute financial product advice. You should consider obtaining independent advice before making any financial decisions.
Health & Biotech
Health & Biotech
Health & Biotech
