Catalyst Pharmaceutical Inc. (NASDAQ: CPRX) has announced that its partner DyDo Pharma has commenced third phase registrational stud in Japan evaluating the safety and efficacy of its FIRDAPSE (amifampridine ) 10 mg tablets for Lambert-Eaton myasthenic syndrome treatment.
DyDo Pharma has FIRDAPSE commercial rights in Japan
Chairman and CEO of Catalyst Patrick McEnany, stated, “We are pleased with the important progress being made by DyDo as we advance on our shared commitment of bringing a novel treatment option to LEMS patients in Japan. The initiation of this Phase 3 program marks an important milestone towards our goal to expand the global footprint of FIRDAPSE for the treatment of LEMS. Currently, there are no approved treatments for this rare autoimmune neuromuscular disorder in Japan, and we believe FIRDAPSE has the potential to provide a meaningful new therapy option to patients living with this disease. We appreciate the collaborative effort of our partnership and look forward to continuing to support DyDo in the clinical advancement of FIRDAPSE.”
In June 2021, Catalyst signed a sub-license deal with DyDo to develop and market FIRDAPSE in Japan. Catalyst will offer commercial and clinical supply to DyDo and technical assistance in obtaining regulatory approval for the tablet from Japanese regulators under the conditions of the agreement. On its part, DyDo will be in charge of the product’s research and commercialization in Japan, pending regulatory approval. The terms of the agreement indicate that Catalyst will be legible to development and sales milestones as well as revenue for the product’s clinical and commercial supply.
FIRDAPSE produces presynap[tic membrane depolarization and slows repolarization
FIRDAPSE is a nonspecific, voltage-dependent potassium (K+) channel blocker that produces presynaptic membrane depolarization and prevents or slows repolarization. Notably, the action mechanism causes slow voltage-dependent calcium (Ca2+) channels to open, allowing for a subsequent Ca2+ influx. As a result, it causes synaptic vesicles holding Acetylcholine (ACh) to exocytose, releasing more ACh into the synaptic cleft and improving neuromuscular transmission and muscle function. Therefore, the Japanese Ministry of Health, Labour, and Welfare designated FIRDAPSE as an orphan medicine.
