) 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
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
) are already there in the myasthenia gravis market and companies
) 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
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