Morcamilast

TOKYO--(BUSINESS WIRE)-- Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Daikichiro Kobayashi) today announced that positive findings from the phase II clinical trial of ME3183, a novel highly-potent selective phosphodiesterase-4 (PDE4) inhibitor, in patients with plaque psoriasis conducted in the United States and Canada (NCT05268016) were presented on 12 October at the European Association of Dermatology and Venereology (EADV) Congress 2023 held in Berlin. The outline of the presentation is as follows: Meiji Seika Pharma evaluated the efficacy and safety of ME3183, a novel oral, highly potent, selective phosphodiesterase-4 inhibitor, characterized by low blood-brain barrier transmission, over 16-week treatment period in adults with moderate to severe plaque psoriasis. In total, 132 patients were randomly assigned to ME3183 (n=26, 26, 26, and 27, respectively) or placebo (n=27). Mean Psoriasis Area and Severity Index (PASI) score at baseline was 15.9–17.6 and 16.8 in the ME3183 and placebo groups, respectively. A significantly greater proportion of patients in the ME3183 5 mg BID, 7.5 mg BID, and 15 mg QD groups achieved ≥75% reduction from baseline PASI score (PASI-75) at Week 16 (primary endpoint) versus placebo (58.3%, 61.5%, and 52.0% vs 14.8%, P<0.001; 10 mg QD group: 32.0%). A greater proportion of patients in the ME3183 groups versus placebo achieved PASI-90, PASI-100, and Static Physician’s Global Assessment 0/1 combined with 2-point reduction (secondary endpoints). Early PASI improvement after administration was observed in the ME3183 groups. The most frequent treatment-emergent adverse events were diarrhea, nausea, and headache. In the ME3183 5 mg BID, 10 mg QD, 7.5 mg BID, 15 mg QD and placebo groups, 2, 2, 4, 3, and 1 patients, respectively, discontinued because of adverse events. ME3183 was well tolerated. No unexpected safety signals were observed. In conclusion, ME3183 administered orally was effective in the treatment of plaque psoriasis and had an acceptable safety profile. Meiji strives to provide efficacious and safe treatment for unmet medical needs, such as psoriasis and other autoimmune diseases. View source version on businesswire.com: Contacts Meiji Pharma USA Inc. Yasushi Miyazawa President Telephone: +1-201-777-7133 E-mail: pr-pharma@meiji.com Source: Meiji Seika Pharma Co., Ltd. View this news release online at:

TOKYO, Japan I August 09, 2023 I Meiji Seika Pharma Co., Ltd. (Headquarters: Tokyo, President and Representative Director: Daikichiro Kobayashi) today announced that ME3183, a novel highly-potent selective phosphodiesterase-4 (PDE4) inhibitor, met the primary endpoint based on “PASI-75”, defined as the proportion of subjects achieving 75% improvement in Psoriasis Area Severity Index (PASI), in phase II clinical trial in patients with moderate-to-severe plaque psoriasis conducted in the United States and Canada. The phase II clinical trial ( NCT05268016 )* was conducted to evaluate the efficacy, safety and tolerability of ME3183 after administered once or twice daily for 16 weeks in patients with moderate-to-severe plaque psoriasis. One-hundred and thirty-two patients were enrolled in the United States and Canada. The primary endpoint was defined as the proportion of subjects achieving 75% improvement (“PASI-75”) in Psoriasis Area Severity Index (PASI) Score at Week 16 from baseline. As a result, significantly greater proportion of PASI-75 achievement were observed in ME3183 treatment groups compared to the placebo group, which met the primary endpoint. In addition, early PASI improvement after administration was observed in ME3183 groups. ME3183 was shown to be safe and well tolerated. Details of the study will be presented at an upcoming medical meeting. ME3183 is an orally-available and selective PDE4 inhibitor discovered by Meiji Seika Pharma. In non-clinical studies, it showed greater anti-inflammatory effect and approximately 30-fold greater inhibitory effect on TNF-α production than the existing orally-available PDE4 inhibitor for psoriasis. At the same time, the distribution of ME3183 in the brain was sufficiently low. Meiji strives to provide efficacious and safe treatment for unmet medical needs, such as psoriasis and other autoimmune diseases. *: Meiji Pharma USA Inc. (Teaneck, NJ, President: Yasushi Miyazawa), a wholly owned subsidiary of Meiji, is in charge of the Phase II clinical trial. SOURCE: Meiji Seika Pharma