Krystal Biotech Announces Completion of Patient Enrollment in the GEM-3 Pivotal Trial of B-VEC for the Treatment of Dystrophic Epidermolysis Bullosa

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[{"type":"text","content":"PITTSBURGH, March 30, 2021 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced that enrollment is complete in the pivotal GEM-3 study of B-VEC for dystrophic epidermolysis bullosa (DEB). Based on the timing of this milestone, Krystal expects to report top-line results from the study in the fourth quarter of 2021. “Completion of enrollment in the GEM-3 study marks a significant milestone for us,” said Suma Krishnan, Founder and Chief Operating Officer of Krystal Biotech. “We would like to extend our gratitude to the patients, caregivers, investigators and study staff who, through their commitment during an especially difficult year, have helped bring us closer to potentially providing an easy-to-use topical treatment that addresses the underlying cause of DEB.” About the GEM-3 Pivotal StudyThe GEM-3 trial is a randomized, double-blind, intrapatient placebo-controlled multicenter study designed to evaluate the efficacy and safety of B-VEC for the treatment of DEB. The trial enrolled 31 patients ranging in ages from one (1) year to forty-four (44) years old. Sixty-one percent (61%) of the patients enrolled were pediatric patients (18 years old or younger). As anticipated, less than ten percent (10%) of enrolled patients have the dominant form of dystrophic epidermolysis bullosa (DDEB). In each patient, a primary wound pair(s) was identified by the investigator; one wound was randomized to receive a weekly topical application of B-VEC and the other to placebo. Primary wound pairs selected in the study fell into each of the three wound area segments of","length":2165,"tagName":"div"}]

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