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Promedior receives European orphan drug designation for PRM-151
MALVERN, Pa. — The European Commission has granted orphan medicinal product designation to Promedior for PRM-151 to prevent scarring after glaucoma filtration surgery, the company announced in a press release.
PRM-151, a natural recombinant human serum protein that targets fibrosis and tissue remodeling, proved safe and effective in preclinical trials. Promedior launched a phase 1 clinical trial in July to test safety, tolerability and biochemical performance of PRM-151 in ascending single intravenous doses, the release said.
"The orphan medicinal product designation for PRM-151 reflects the therapeutic potential of PRM-151 to prevent scarring post glaucoma filtration surgery and the lack of approved alternative therapies for this serious surgical complication," Dominick Colangelo, Promedior CEO, said in the release. "This designation provides Promedior significant development and commercial advantages as we continue the development of this first-in-class therapy for the treatment of diseases involving scarring and fibrosis in the eye and other organ systems."
Orphan medicinal product designation offers various benefits, such as 10 years of marketing exclusivity, protocol assistance and scientific advice during product development, the release said. The designation is intended to nurture the development of products indicated for rare, life-threatening or disabling conditions, according to the release.