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iX Biopharma reports success of single-dose Wafermine clinical trials
SPECIALTY pharmaceutical company iX Biopharma on Thursday said its Phase 2a and 2b clinical trials for its lead product, Wafermine, have proven successful.
The results confirmed a rapid onset of pain relief, along with good tolerability, it said. Wafermine is one of three iX Biopharma products currently under development.
The company listed on Singapore Exchange's Catalist board in July 2015.
The clinical trials, conducted over the past one year, were designed to show the effectiveness and rapid onset of action of Wafermine, and to determine the dosage scheme for the pivotal Phase 3 clinical trials.
The two Phase 2 studies were conducted in the United States with 200 patients who had just undergone the extraction of impacted wisdom teeth. Some were given different amounts of the drug in single doses, while others were given a placebo.
The results showed that all doses rapidly reduced pain within 10 minutes of administration and were well-tolerated by the patients - consistent with scientific studies demonstrating the efficacy and safety of low-dose ketamine administration in pain management.
Dr Paul Rolan, director of drug development at iX Biopharma, said: "These results put us in an excellent position to complete the clinical development programme, which will deliver a new alternative in management of severe pain."
With the positive results of the single-dose studies, the group has begun preparations to conduct a limited study for Wafermine that is designed for multiple dosing before embarking on the Phase 3 trials next year.
The company's shares added 1.5 cents or 5.6 per cent to S$0.285 on the stock market on Thursday.