Island's phase 2a/b dengue results in May
High level results of PROTECT trial which included two patient cohorts to be reported next month
Pharmacokinetic data from phase 2b cohort received with dosing regimen achieving target blood concentration in all participants
Special Report: Antiviral drug development company Island Pharmaceuticals has completed treatment follow up in its phase 2a/b PROTECT trial using lead candidate ISLA-101 in dengue fever with results expected next month.
The Island Pharmaeutical (ASX:ILA) phase 2a/b PROTECT trial included two patient cohorts, with the Phase 2a arm examining the prophylactic (preventative) arm of ISLA-101 in dengue fever in four subjects randomised 3:1 (active:placebo).
The phase 2b arm involves 10 subjects, randomised 8:2 (active:placebo) and is assessing if ISLA-101 can reduce virus level and symptoms in subjects already infected with the dengue challenge virus, a weakened strain of dengue virus developed by the US Army.
During phase 2a, the trial's safety review committee (SRC) deemed ISLA-101 safe and exhibited evidence of anti-dengue activity.
The SRC noted that blood levels of ISLA-101 were as desired, and given positive safety and antiviral signals, recommended that Island proceed with the Phase 2b therapeutic cohort.
The SRC's recommendation was submitted to the US Food and Drug Administration (FDA) as requested by the regulator, which led to the start of phase 2b of the trial.
Island subsequently completed Phase 2b enrolment and dosing on schedule and with no delays in February.
Follow-up procedures necessary to obtain samples to analyse primary and secondary endpoints for the Phase 2b cohort have also been successfully completed.
Data obtained and pending results
Island has received pharmacokinetic (PK) data from the Phase 2b cohort, which showed target blood concentration in all subjects was achieved.
The company said data to examine virus levels from Phase 2a and 2b was expected by the end of this month.
Upon receipt and analysis of the data, Island anticipates locking the study database within around two weeks, after which all data will be unblinded.
Following close consultation with regulatory advisors and Island's scientific consultants and given the short time between receipt of data and locking the database, Island said it had decided not to undertake an interim readout.
Moreover, the FDA has not requested an interim review of data, in contrast to their request following the Phase 2a cohort.
Island said this would serve to maintain its data integrity, preserve statistical power of the results and have a positive impact on future engagement with regulatory bodies.
Island expects that high level, unblinded data for both cohorts will be reported before the end of May.
Potential of ISLA-101 to treat and prevent dengue
Dengue fever is the most prevalent mosquito-borne viral disease and, according to the World Health Organization, its incidence has grown dramatically around the world in recent decades, with no specific treatment.
CEO and managing director Dr David Foster said Island was pleased to provide an update the Phase 2a/b PROTECT trial, which has the potential to show ISLA-101's use in both a preventative and therapeutic for dengue.
'Following completion of patient follow up for phase 2b cohort, I am pleased to advise that the trial was executed to the highest standard, per our protocol which was previously approved by the US FDA,' he said.
'Further to this, the receipt of initial PK data has shown that desired target blood concentration of ISLA-101 was achieved in Phase 2b participants, similar to what was observed in Phase 2a subjects.
'Following receipt of strong interim data from the phase 2a cohort, the board and management remain confident in the pending results and look forward to providing additional updates in the coming weeks.'
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.
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