FDA Grants Orphan Drug Designation to Prometic’s PBI-4050 for Alström Syndrome

March 10, 2017

Prometic has been granted orphan drug designation by the FDA for its orally active, anti-fibrotic, lead drug candidate, PBI-4050, for the treatment of Alstrӧm Syndrome.

The company is currently investigating the effects of PBI-4050 on multiple organs in an ongoing, open-label, Phase II clinical study in the UK. Prometic said an expansion of the clinical program is contingent on regulatory guidance from the FDA and EMA.

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