— Top-Line Results Expected in Early December —
— Required Abuse Liability Studies Completed —
CORAL GABLES, FL, USA I October 31, 2017 I Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced the completion of enrollment in the LMS-003 Phase 3 trial evaluating Firdapse® (amifampridine phosphate) in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
“Completion of enrollment in LMS-003 marks a significant milestone for Catalyst as well as the LEMS community as we take another step toward advancing treatment for LEMS patients,” commented Patrick J. McEnany, Chief Executive Officer of Catalyst. “We would like to express our thanks to the dedicated investigators and clinical site coordinators who are conducting the trial and also patients with LEMS and their caregivers who are participating. We look forward to reporting top-line results in early December.”
As previously reported, Catalyst is also conducting preclinical abuse liability studies required by the FDA’s guidance for “Assessment of Abuse Potential of Drugs” that was finalized in January 2017. Catalyst has completed all three studies for Self-Administration, Physical Dependence, and Drug Discrimination. Top-line results indicate that amifampridine phosphate does not exhibit abuse potential in these assessment models. Catalyst remains confident that no further preclinical or clinical studies for abuse liability will be required.
Catalyst’s second Phase 3 trial, LMS-003, is a double-blind, placebo controlled withdrawal trial, which enrolled a total of 26 subjects. The co-primary endpoints remain the same as Catalyst’s first Phase 3 trial evaluating Firdapse for the treatment of LEMS, including change from Baseline Quantitative Myasthenia Gravis (QMG) score, and change in Subject Global Impression (SGI) score.
Catalyst is also developing Firdapse for the treatment of MuSK antibody positive myasthenia gravis (MuSK-MG) and congenital myasthenic syndromes (CMS).
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), MuSK antibody positive myasthenia gravis, and infantile spasms. Firdapse® has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LEMS and Orphan Drug Designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.
Catalyst is also developing CPP-115 to treat refractory infantile spasms, and possibly refractory Tourette’s Disorder. CPP-115 has been granted U.S. Orphan Drug Designation for the treatment of infantile spasms by the FDA and has been granted E.U. Orphan Medicinal Product Designation for the treatment of West syndrome by the European Commission. In addition, Catalyst is developing a generic version of Sabril® (vigabatrin).
SOURCE: Catalyst Pharmaceuticals
Post Views: 32
— Top-Line Results Expected in Early December —
— Required Abuse Liability Studies Completed —
CORAL GABLES, FL, USA I October 31, 2017 I Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, today announced the completion of enrollment in the LMS-003 Phase 3 trial evaluating Firdapse® (amifampridine phosphate) in patients with Lambert-Eaton Myasthenic Syndrome (LEMS).
“Completion of enrollment in LMS-003 marks a significant milestone for Catalyst as well as the LEMS community as we take another step toward advancing treatment for LEMS patients,” commented Patrick J. McEnany, Chief Executive Officer of Catalyst. “We would like to express our thanks to the dedicated investigators and clinical site coordinators who are conducting the trial and also patients with LEMS and their caregivers who are participating. We look forward to reporting top-line results in early December.”
As previously reported, Catalyst is also conducting preclinical abuse liability studies required by the FDA’s guidance for “Assessment of Abuse Potential of Drugs” that was finalized in January 2017. Catalyst has completed all three studies for Self-Administration, Physical Dependence, and Drug Discrimination. Top-line results indicate that amifampridine phosphate does not exhibit abuse potential in these assessment models. Catalyst remains confident that no further preclinical or clinical studies for abuse liability will be required.
Catalyst’s second Phase 3 trial, LMS-003, is a double-blind, placebo controlled withdrawal trial, which enrolled a total of 26 subjects. The co-primary endpoints remain the same as Catalyst’s first Phase 3 trial evaluating Firdapse for the treatment of LEMS, including change from Baseline Quantitative Myasthenia Gravis (QMG) score, and change in Subject Global Impression (SGI) score.
Catalyst is also developing Firdapse for the treatment of MuSK antibody positive myasthenia gravis (MuSK-MG) and congenital myasthenic syndromes (CMS).
About Catalyst Pharmaceuticals
Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating, chronic neuromuscular and neurological diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), MuSK antibody positive myasthenia gravis, and infantile spasms. Firdapse® has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the treatment of LEMS and Orphan Drug Designation for LEMS, CMS and myasthenia gravis. Firdapse is the first and only approved drug in Europe for symptomatic treatment in adults with LEMS.
Catalyst is also developing CPP-115 to treat refractory infantile spasms, and possibly refractory Tourette’s Disorder. CPP-115 has been granted U.S. Orphan Drug Designation for the treatment of infantile spasms by the FDA and has been granted E.U. Orphan Medicinal Product Designation for the treatment of West syndrome by the European Commission. In addition, Catalyst is developing a generic version of Sabril® (vigabatrin).
SOURCE: Catalyst Pharmaceuticals
Post Views: 32
