FSD Pharma has hired Australian CRO iNGENu to run the next volunteer study of Lucid-21-302, a candidate treatment for multiple sclerosis (MS).
The contract – financial terms of which were not disclosed – will see the Melbourne-based clinical trial services firm test the drug in healthy volunteers on behalf of Canada-based FSD’s local subsidiary, Huge Biopharma Australia.
FSD CEO Zeeshan Saeed said "We are very pleased to formalize this agreement and to collaborate with iNGENu to conduct this clinical study.
This was echoed by Andrzej Chruscinski, vice-president, scientific and clinical affairs at FSD Pharma, who outlined the next steps.
"We are very eager to complete this clinical trial as efficiently as possible, and are encouraged by the strong data from the prior Phase 1 single ascending dose study supporting the safety and tolerability of Lucid-21-302."
"Over the next several days and weeks, our R&D team will closely work with iNGENu to start this clinical study swiftly,” he said.
In an earlier Phase I clinical trial, Lucid-21-302 was shown to be safe and well-tolerated in the dose range of 50-300 mg. According to the Clinicaltrials.gov website listing, the study was conducted by Biopharma Services Incorporated in Toronto, Canada.
The Lucid-21-302 deal follows just a few weeks after Huge Biopharma contracted iNGENu to run a Phase I trial of a product called unbuzzd, which is a fortified oral liquid formula that potentially enhances cognition, replenishes cofactors needed for alcohol metabolism.
At the time Huge said the aim of the study is to determine if unbuzzd accelerates the rate of alcohol metabolism in people who have consumed alcohol, allowing them to sober up faster.
FSD sits alongside RespireRx Pharmaceuticals, Albert Labs International Corp, and Lobe Sciences on iNGENu’s publicly acknowledged list of international clinical trial clients.
On its website the contract research organization (CRO) states that it offers access to the Australian Federal Government's R&D incentive program, which will provide cash rebates for 43.5% of all eligible costs relating qualifying studies.
Unsplash/chrisliverani