Clinuvel Pharmaceuticals (ASX:CUV) reported positive results from a post-authorization study of its Scenesse drug candidate in adolescent erythropoietic protoporphyria patients, according to a Monday Australian bourse filing.
Erythropoietic protoporphyria is a hereditary disorder characterized by skin sensitivity to sunlight and some artificial light.
Preliminary results from the study in adult and adolescent patients showed that the drug candidate was well tolerated by all patients enrolled in the study, with the safety profile consistent with that reported in long-term adult use.
The controlled-release profile of the Scenesse implant in adolescent patients was similar to that observed in earlier studies in adults.
A total of 28 patients were assessed, including 14 adults and 14 adolescents, with ages ranging between 12 years and 17 years, the filing said. It added that all eligible enrolled patients elected to receive further treatment in 2024 or this year.
Data from the study will be included in a regulatory package the firm is planning to submit in support the expansion of the Scenesse indication to include treatment of adolescent patients.
The company's shares fell nearly 1% in early trading on Monday.
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