Island Pharmaceuticals Ltd (ASX: ILA) shares are catching the eye on Wednesday.
In morning trade, the ASX pharmaceutical stock rocketed as much as 70% to a 52-week high of 28 cents.
Why is this ASX pharmaceutical stock rocketing?
Investors have been scrambling to buy the antiviral drug development company's shares this morning after it released an update on the Phase 2a cohort of the PROTECT Phase 2a/b trial.
In this Phase 2a trial, subjects received the company's ISLA-101 product candidate before being bravely infected with a weakened dengue virus developed by the US Army. The trial aims to assess whether ISLA-101 can prevent or reduce viremia and symptoms, compared to placebo control.
As you might have guessed from the way the ASX pharmaceutical stock is rocketing today, the results of the trial have been very encouraging.
According to the release, ISLA-101 has shown safety and anti-dengue activity in the Phase 2a cohort trial.
The Safety Review Committee (SRC) further noted that blood levels of ISLA -101 were seen as expected. In light of this and given positive safety and efficacy signals, it has recommended that Island Pharmaceuticals proceed with the therapeutic Phase 2b cohort.
The company notes that that recommendation will now be filed with the US FDA 30 days before starting the Phase 2b cohort.
The 'most exciting' achievement of the year
The ASX pharmaceutical stock's CEO and managing director, Dr David Foster, was delighted with the news. He said:
Through the past 12 months, we have recorded several important achievements, but this one stands out as the most exciting — and the very reason we started this company. 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. 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 Pharmaceuticals advised that it is now in the process of preparing to submit the SRC report to US FDA, with the report expected to be submitted in the coming days. If all goes to plan and the regulator agrees, the company remains on target to start the Phase 2b cohort in January 2025.
Following today's monster gain, the company's shares are up 300% since this time last year.
