ME3183 / Meiji Seika - LARVOL DELTA

Efficacy and safety of ME3183, an oral phosphodiesterase 4 inhibitor, in patients with plaque psoriasis. (PubMed, J Eur Acad Dermatol Venereol) - "ME3183 should be further investigated as a safe and effective treatment alternative for moderate to severe plaque psoriasis."

Clinical • Journal • Dermatology • Immunology • Pain • Psoriasis

ME3183, a Novel and Promising Oral PDE4 Inhibitor for Psoriasis, has Highly Potent Inhibitory Effects on Th2 Cytokine Production and Histamine-Induced Vascular Permeability (EADV 2024) - "ME3183 and marketed oral PDE4 inhibitors (apremilast and roflumilast) were orally administered at different time points (1, 2 and 4 hrs) prior to the histamine challenge. ME3183 inhibited Th2 cytokines more potently than existing oral PDE4 inhibitors and significantly suppressed histamine-induced vascular permeability. Previous studies have demonstrated the efficacy of ME3183 in a model of type IV hypersensitivity reaction (Kubota-Ishida N et al. Eur J Pharmacol."

Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Inflammation • Psoriasis • IL13 • IL4

Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=132 | Completed | Sponsor: Meiji Pharma USA Inc. | Phase classification: P2a ➔ P2

Phase classification • Dermatology • Immunology • Psoriasis

Safety, Tolerability, and Pharmacokinetics of a Novel Oral Phosphodiesterase 4 Inhibitor, ME3183: First-in-Human Phase 1 Study. (PubMed, Clin Pharmacol Drug Dev) - "Pharmacokinetic analysis showed dose-dependent increases in C and AUC, with later t and longer t than apremilast, an approved PDE4 inhibitor. In the MAD part, plasma exposure levels of ME3183 were higher even at the minimal dose (2.5 mg twice daily) than the estimated therapeutically effective level. These results show the safe profile of ME3183 and support further studies to confirm the safety and efficacy of the drug in patients with psoriasis and other inflammatory diseases."

Journal • P1 data • PK/PD data • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Inflammation • Pain • Psoriasis

ME3183, a novel phosphodiesterase-4 inhibitor, exhibits potent anti-inflammatory effects and is well tolerated in a non-clinical study. (PubMed, Eur J Pharmacol) - "The launched PDE4 inhibitors apremilast, crisaborole, and roflumilast have not exhibited sufficient inhibitory potential due to poor margins of effectiveness and tolerability. These wide margins demonstrate the effectiveness of ME3183 in treating many inflammatory diseases, such as psoriasis and atopic dermatitis. An on-going phase 2 trial is expected to further demonstrate the efficacy and safety of ME3183."

Journal • Atopic Dermatitis • CNS Disorders • Dermatitis • Dermatology • Immunology • Oncology • Pruritus • Psoriasis • IL4 • TNFA

Meiji Seika Pharma Presents Positive Findings from Phase II Study of ME3183, Novel Highly-Potent Selective PDE4 Inhibitor, in Patients With Plaque Psoriasis at EADV Congress 2023 (Businesswire) - P2a | N=132 | NCT05268016 | Sponsor: Meiji Pharma USA Inc. | "Meiji Seika Pharma Co., Ltd....today announced that positive findings from the phase II clinical trial of ME3183...in patients with plaque psoriasis...were presented on 12 October at the European Association of Dermatology and Venereology (EADV) Congress 2023 held in Berlin....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)."

P2a data • Immunology • Psoriasis

Meiji Seika Pharma Announces Positive Results in Phase II Study of ME3183, a Novel Highly-Potent Selective PDE4 Inhibitor, in Patients With Moderate-to-Severe Plaque Psoriasis in the United States and Canada (Businesswire) - P2a | N=132 | NCT05268016 | Sposnor: Meiji Pharma USA Inc. | "Meiji Seika Pharma Co., Ltd...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....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."

P2a data • Immunology • Psoriasis

Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2a | N=132 | Completed | Sponsor: Meiji Pharma USA Inc. | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Immunology • Psoriasis

Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2a | N=125 | Active, not recruiting | Sponsor: Meiji Pharma USA Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2a | N=125 | Recruiting | Sponsor: Meiji Pharma USA Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Dermatology • Immunology • Psoriasis

Meiji Seika Pharma: First Patient Dosed in Phase II Study of ME3183, a Selective PDE4 Inhibitor, in Patients with Plaque Psoriasis in the United States and Canada (Businesswire) - "Meiji Seika Pharma Co., Ltd...today announced that the first patient was dosed in Phase II clinical trial of ME3183, a selective phosphodiesterase-4 (PDE4) inhibitor, in patients with plaque psoriasis in the United States and Canada....The Phase II clinical trial is a randomized, double-blind, placebo-controlled study 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 twenty-five patients are planned to be enrolled at approximately 30 facilities in the United States and Canada....Meiji Pharma USA Inc...a wholly owned subsidiary of Meiji, is in charge of the Phase II clinical trial."

Trial status • Immunology • Psoriasis

Efficacy and Safety of ME3183 in Subjects With Moderate to Severe Plaque Psoriasis (clinicaltrials.gov) - P2a | N=125 | Not yet recruiting | Sponsor: Meiji Pharma USA Inc.

New P2a trial • Dermatology • Immunology • Psoriasis

Meiji Completed Phase I Studies and Moves Onto Phase II Study of ME3183, a Selective PDE4 Inhibitor for the Treatment of Psoriasis (Businesswire) - P1, N=NA; "Meiji Seika Pharma Co., Ltd...announced that it has successfully completed Phase I clinical trials of ME3183, a selective PDE4 inhibitor, conducted in the United States. ME3183 has been shown to be safe and well-tolerated across the doses tested. Based on these results, Meiji plans to initiate a Phase II clinical trial in patients with plaque psoriasis in the United States and Canada in the first quarter of 2022."

New P2 trial • P1 data • Psoriasis