CNP-106 / Cour Pharma - LARVOL DELTA

COUR Pharma Secures FDA Orphan Drug Designation for CNP-106 in Generalized Myasthenia Gravis (GlobeNewswire) - "COUR Pharma is currently enrolling people aged 18-75 years old who test positive for anti-acetylcholine receptor antibodies and have a Myasthenia Gravis Foundation of America (MGFA) Class II-IV diagnosis of gMG in a Phase 1b/2a double-blind, randomized, placebo-controlled clinical trial (NCT06106672) to evaluate the safety, tolerability, pharmacodynamics, and efficacy of multiple ascending doses of CNP-106."

Orphan drug • Trial status • Myasthenia Gravis

Antigen-specific immune therapy (CNP-106) for treatment of generalised myasthenia gravis: rationale and design of first-in-human randomised controlled trial. (PubMed, BMJ Neurol Open) - P1/2 | "Trial results will be communicated to participants, presented at national and international meetings and published in peer-reviewed journals. NCT06106672."

Journal • P1 data • CNS Disorders • Immunology • Myasthenia Gravis

COUR Pharmaceuticals Doses First Patient in Phase 1b/2a Clinical Trial Evaluating CNP-106 in Generalized Myasthenia Gravis (GlobeNewswire) - "COUR Pharmaceuticals...today announced that the first patient has been dosed in its Phase 1b/2a proof-of-concept clinical trial evaluating CNP-106 as a potential treatment for people living with generalized myasthenia gravis (gMG)....The Phase 1b/2a double-blind, randomized, placebo-controlled clinical trial...will enroll up to 54 patients with gMG, aged 18-75, to evaluate the safety, tolerability, pharmacodynamics, and efficacy of multiple ascending doses of CNP-106."

Trial status • Myasthenia Gravis

Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis (clinicaltrials.gov) - P1/2 | N=54 | Recruiting | Sponsor: COUR Pharmaceutical Development Company, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • CNS Disorders • Myasthenia Gravis

Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis (clinicaltrials.gov) - P1/2 | N=54 | Not yet recruiting | Sponsor: COUR Pharmaceutical Development Company, Inc. | Phase classification: P1b/2a ➔ P1/2 | Initiation date: Jan 2024 ➔ Apr 2024

Phase classification • Trial initiation date • CNS Disorders • Myasthenia Gravis

Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis (clinicaltrials.gov) - P1/2 | N=54 | Not yet recruiting | Sponsor: COUR Pharmaceutical Development Company, Inc. | Trial completion date: Jan 2027 ➔ Aug 2026 | Trial primary completion date: Jan 2027 ➔ Jun 2026

Trial completion date • Trial primary completion date • CNS Disorders • Myasthenia Gravis

Evaluate the Safety, Tolerability, Pharmacodynamics and Efficacy of CNP-106 in Subjects With Myasthenia Gravis (clinicaltrials.gov) - P1/2 | N=54 | Not yet recruiting | Sponsor: COUR Pharmaceutical Development Company, Inc.

New P1/2 trial • CNS Disorders • Myasthenia Gravis