Bad news has come from Cytokinetics' (CYTK) top-line results of BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS). Bottom line, BENEFIT-ALS trial did not achieve its primary efficacy endpoint, the mean change from baseline in the ALS Functional Rating Scale in its revised form (ALSFRS-R) on tirasemtiv versus placebo (-2.98 points in the tirasemtiv group versus -2.40 points in the placebo group, p = 0.11). Another ambitious attempt to decrease some of ALS burden on the sufferers has disappointed.
Detailed results will be presented during the 66th Annual Meeting of the American Academy of Neurology on April 29th in Philadelphia, PA.
Secondary efficacy analyses of the effect of tirasemtiv on respiratory function and other measures of skeletal muscle function produced mixed results.
Regarding the skeletal muscle activator tirasemtiv, the drug might still have the chance to bring positive results in less difficult conditions than ALS such as myasthenia gravis, cachexia complicating heart failure cancer, claudication, sarcopenia and frailty associated with aging.
More important for CYTK now is Omecamtiv mecarbil, the small-molecule direct activator of cardiac myosin. The drug is a potential treatment of heart failure. Omecamtiv mecarbil is now in Amgen’s (AMGN) hands being evaluated in both intravenous and oral formulations for heart failure patients from in-hospital to outpatient settings.
Good news coming from Amgen would be huge for Cytokinetics. On the other hand, bad news would be detrimental.
We are waiting for Amgen’s heart failure trial results.
------- ------- -------- --------
We are still working on Gilead (GILD) article and we hope we can post it in a few hours. It is an important article, as it describes the chronology and tactics that have been and are continuing to be used to delay a huge rally in GILD, which would match the unprecedented excellent news coming from the firm’s HCV treatments.
FORWARD-LOOKING: Material presented here is for informational purposes only. Nothing in this article should be taken as a solicitation to purchase or sell securities. Before buying or selling any stock you should do your own research and reach your own conclusion. Further, these are our 'opinions' and we may be wrong. We may have positions in securities mentioned in this article. You should take this into consideration before acting on any advice given in this article. If this makes you uncomfortable, then do not listen to our thoughts and opinions. The contents of this article do not take into consideration your individual investment objectives so consult with your own financial adviser before making an investment decision. Investing includes certain risks including loss of principal.