Catalyst Pharmaceuticals Completes Enrollment in Second Phase 3 Trial of Firdapse® in Patients with Lambert-Eaton Myasthenic Syndrome
-- Top-Line Results Expected in Early December --
-- Required Abuse Liability Studies Completed --
"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
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
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).
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).
This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst's actual results in future periods to differ materially from forecasted results. A number of factors, including whether the receipt of breakthrough therapy designation for Firdapse will expedite the development and review of Firdapse by the FDA or the likelihood that the product will be found to be safe and effective, the timing of Catalyst's second trial evaluating Firdapse for the treatment of LEMS and whether the trial will be successful, whether any additional abuse liability studies of Firdapse will be required
Brian Korb The Trout Group LLC(646) 378-2923 firstname.lastname@example.org Media Contact David Schull Russo Partners(212) 845-4271 email@example.com Company Contact Patrick J. McEnany Catalyst PharmaceuticalsChief Executive Officer (305) 420-3200 firstname.lastname@example.org
News Provided by Acquire Media