Minoryx Therapeutics, a registration stage biotech company focused on the development of therapies for orphan central nervous system (CNS) disorders, announced the US Food and Drug Administration (FDA) approval of its Phase 3 clinical trial (CALYX) of lead candidate leriglitazone, to treat adult male X-linked Adrenoleukodystrophy (X-ALD) patients with cerebral Adrenoleukodystrophy (cALD).

The CALYX protocol has received both FDA and central IRB approval. Significant preparations for the trial commencement have been completed and patient recruitment is expected to start by the end of Q2 2023 with results anticipated by late 2025.

“Minoryx is focused on bringing therapeutic options to X-ALD patients and we now have an agreed route to the US market with a Phase 3 trial designed to confirm the disease modifying potential of leriglitazone.” said Marc Martinell, CEO, Minoryx and added: “CALYX will be funded from the Series C financing together with proceeds from our European strategic collaboration with Neuraxpharm. We look forward to initiating this trial which could provide an important therapeutic optionfor patients suffering from this devastating orphan disease with a major unmet medical need.”

CALYX will enroll 40 adult male X-ALD patients with progressive cALD defined by the presence of gadolinium enhancing brain lesions. CALYX will be conducted across selected centers of excellence in the US and South America and Minoryx has appointed Dr Ali Fatemi at the Kennedy Krieger Institute in Baltimore, US as the Global Principal Investigator for CALYX.