Quantum Biopharma opts for Australia for Phase II MCAS/D pain drug trial

Canada’s Quantum Biopharma has hired Australian contractor Ingenu CRO to run a Phase II trial of FSD202, a candidate treatment for chronic pain associated with the immune condition mast cell activation syndrome.

The contract – which financial terms were not disclosed – will see Ingenu run the trial at various sites across Australia and provide regulatory, clinical monitoring and data management services.

FSD202 — ultra-micronized palmitoylethanolamide (PEA) — is being developed to treat inflammatory disorder-related pain. It targets the neuroimmune pathways implicated in both mast cell dysregulation and centrally mediated pain processing.

Sud Agarwal, Ingenu’s chief medical officer, said, “Patients with MCAS-related nociplastic pain often have no effective treatment options.

“By designing and operationalizing this trial in Australia, Ingenu CRO is helping to fast-track potentially transformative therapies through the clinical development pipeline,” he said.

Plans for the Phase II study were approved by an ethics committee in May.

At the time, Quantum CEO, Zeeshan Saeed, said, “We are delighted to receive HREC approval to proceed with our planned efficacy Phase II clinical trial of FSD202. Our clinical team has worked tirelessly to develop the clinical trial protocol.”

Australian surge

News of the contract comes weeks after Ingenu predicted a surge in demand for clinical trial services in Australia.

At the time, the Melbourne-based firm said NIH budget cuts, regulatory slowdowns, and surging domestic costs are seeing more US sponsors opt to evaluate drugs in the country.

Ingenu also cited Australian rules that allow trials to begin without an open IND as a key difference from the US regulatory system

In a press statement Agarwal said, “What used to be known primarily as a Phase I destination is now the new epicenter for Phase II and III trials.

“Our partners value our ability to deliver full-service global trials without the regulatory bottlenecks they face at home. We are eliminating friction while preserving scientific integrity and data quality,” he said.

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