Cytokinetics, Incorporated (CYTK) recently provided an update on BENEFIT-ALS (Blinded Evaluation of Neuromuscular Effects and Functional Improvement with Tirasemtiv in ALS), the phase IIb study being conducted on its amyotrophic lateral sclerosis (:ALS) candidate, tirasemtiv.
The company reported a programming error in the multinational, double-blind, randomized, placebo-controlled study which is evaluating the safety, tolerability and efficacy of tirasemtiv.
Cytokinetics’ data management vendor reported that due to a programming error in the electronic data capture system controlling study drug assignment, 58 patients received placebo at a certain study visit instead of tirasemtiv.
The company said that no incorrect treatment was conducted on the patients in the placebo arm. Cytokinetics said that the company as well as trial site personnel remained blinded to the 58 patients affected by the error.
Cytokinetics is taking measures to confirm that no other such errors have been made and the programming defect has been corrected. Cytokinetics also conducted an ad hoc meeting of the study`s Data Safety Monitoring Board (:DSMB) to determine that the safety of the 58 patients affected by the error has not been impacted. The DSMB reviewed the safety data and reported that there were no concerns regarding patient safety.
Patient enrolment for the BENEFIT-ALS study is ongoing – the study, which is designed to enroll up to 500 patients, has enrolled 450 patients so far. Cytokinetics said that it may change the current protocol so as to enroll additional patients.
The company is working with regulatory authorities on the most suitable way to respond to the error so that the intended scientific value of BENEFIT-ALS may be maintained.
We do not expect the programming error to have a major impact as the study remains blinded and the error was detected well before final analysis. Moreover, the safety profile was not impacted.
Still, we believe the company will most likely amend the protocol and enroll additional patients. On its first quarter 2013 conference call, the company had said that results from the BENEFIT-ALS study would be out by year end. However, enrolment of additional patients could push out study results by a few months to early 2014. Study costs will also go up.
An update on the company’s plans should be available following discussions with regulatory authorities.
Cytokinetics currently carries a Zacks Rank #2 (Buy). We expect investor focus to remain on results from the ATOMIC-HF study that is evaluating omecamtiv mecarbil in patients with left ventricular systolic dysfunction who are hospitalized with acute heart failure. The company intends to present results in late August-early September.
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