Cytokinetics Inc. (CYTK) recently announced positive results on tirasemtiv from the phase IIa “Evidence of Effect” study which was conducted in patients suffering from generalized myasthenia gravis (MG).
Patients in the phase IIa Evidence of Effect study (CY 4023) received single, oral, double-blind doses of placebo and doses of (250 mg and 500 mg) of tirasemtiv randomly after gaps of one week. The primary objective of the study was to evaluate the effect of tirasemtiv on various measures of muscle strength, muscle fatigue and pulmonary function. As CY 4023 was a hypothesis-generating trial, no single primary efficacy objective was stated earlier.
Results from the CY 4023 study revealed that six hours after dosing, a statistically significant improvement was noticed in the Quantitative MG score (QMG), which is a measure of disease severity widely used by physicians in clinical trials of patients suffering from MG. Patients on tirasemtiv also showed improvements in predicted forced vital capacity compared to placebo.
Both doses of tirasemtiv were well tolerated among the 32 patients who were enrolled in the phase IIa study. Cytokinetics did not report any premature termination or any serious adverse event from the study. Cytokinetics expects to report more data from the CY 4023 study after further analyses.
We note that companies like Valeant Pharmaceuticals (VRX) are already there in the myasthenia gravis market and companies like Alexion Pharmaceuticals (ALXN) are looking to enter the market.
Cytokinetics stated in its press release that myasthenia gravis affects between 50,000 to 85,000 people in the US. About 13,600 new cases are reported each year.
Cytokinetics is also evaluating tirasemtiv in a phase IIb clinical trial, BENEFIT-ALS, for the treatment of amyotrophic lateral sclerosis (ALS). In October this year, the company started enrollment for this trial.
We currently have a Neutral recommendation on Cytokinetics. The stock carries a Zacks #2 Rank (Buy rating) in the short run.
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