Disc teases potential NDA for rare skin disorder drug [Yahoo! Finance]
CLINUVEL PHARMS LTD S/ADR (CLVLY)
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Source: Yahoo! Finance
Following an end of Phase II meeting, the FDA indicated support for an accelerated approval application based on existing clinical data, with the upcoming Phase III trial serving as a confirmatory study. The agency has agreed with Disc's proposed trial design and endpoints, including the use of protoporphyrin IX (PPIX) reduction as a surrogate marker. This potential approval would hinge on bitopertin's ability to enable pain-free sunlight exposure for patients with EPP and X-linked protoporphyria (XLP). EPP is a genetic disorder that causes a phototoxic heme precursor to build up in the red blood cells. Both conditions are associated with severe burn injuries on the skin after as little as ten minutes of exposure to visible light. Data from the Phase II trial showed that once-daily doses of bitopertin at 20mg and 60mg were well tolerated over 24 weeks in 22 patients, with no serious adverse events reported. Participants also had the option to continue in an open-label extension o
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