A territorial licensing deal for a drug for rare CNS diseases was struck this month between Spanish biotech, Minoryx Therapeutics and German-headquartered Neuraxpharm GmbH.
Leriglitazone is a novel oral drug. It works by restoring mitochondrial function and energy production, leading to increased neuronal survival and decreased neurite degeneration. It is currently in clinical development for multiple orphan CNS disorders.
The lead indication for leriglitazone is X-linked Adrenoleukodystrophy (X-ALD), a neurodegenerative disease that exists in two forms: a chronic form, adrenomyeloneuropathy (AMN) and an acute form, cerebral ALD (cALD).The global incidence of X-ALD is estimated at 6.2 per 100,000 live births (compared with ~ 5 per 100,000 live births for Rett syndrome).
Leriglitazone completed a phase 2/3 study last year in the EU and US in the chronic form of X-ALD, AMN. The study failed to meet its primary endpoint, change from baseline in the 6-minute walk test, but a statistical and clinically meaningful difference was observed in early symptomatic patients. An open-label extension phase of this study is still ongoing as well as a separate study in paediatric cALD. A Phase 3 study for leriglitazone in Friedreich's Ataxia is also being planned.
Minoryx believes the Phase 2/3 results in AMN are sufficient for approval and submitted a marketing authorization application, for adult male X-ALD patients, to the EMA two months ago. It is still talking to the FDA in the US, where it has retained rights to leriglitazone.
Neuraxpharm has signed up for the European rights to leriglitazone in CNS indications. Minoryx was paid “a significant double-digit up-front payment” and could earn up to A$388m more in milestone payments and development funding. It will also receive tiered double-digit royalties on product sales.
https://www.minoryx.com/
https://www.minoryx.com/media/minor...leriglitazone_in_adrenomyeloneuropathy_(amn)/
https://www.pharmiweb.com/press-rel...erapy-for-rare-cns-disease-patients-in-europe
https://www.bioworld.com/articles/6...on-european-rights-to-leriglitazone?v=preview
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