Expert Interview
A Discussion of the future of Cytokinetic's omecamtiv mecarbil for heart failure after failing primary efficacy endpoint and showing signs of adverse effects
Ticker(s): CYTK, AMGNAn expert with extensive knowledge of the development of omecamtiv mecarbil and data from the clinical trials. Additionally, someone with experience treating heart failure patients with the current treatments
Can you briefly describe the experience you have treating acute heart failure (AHF) patients?
Added By: camawhinneyWhat are the current treatments for AHF? What is the current standard of care for these patients?
Added By: camawhinneyCan you describe the process for treating patients now that experience AHF?
Added By: camawhinneyIn the ATOMIC-AHF Phase 2b study in 2013, the primary endpoint tested omecamtiv mecarbil efficacy of dyspnea (shortness of breath) response. This study did not meet the primary endpoint, with the dyspnea response in the omecamtiv mecarbil treatment groups not being statistically different than the placebo group (p=0.33). How significant is this data?
Added By: camawhinneyThe ATOMIC-AHF study tested for dyspnea response. Is this the only course of treatment for patients with AHF? If not, what other courses of treatment exist?
Added By: camawhinneyThe ATOMIC-AHF study showed favorable dose and concentration-related trends on dyspnea response. Does this improve omecamtiv mecarbil's position as a possible treatment in the future?
Added By: camawhinneyA recent COSMIC-HF study in 2015 tested for dose escalation. How significant is the dose concentration tests for omecamtiv mecarbil's outlook to be continued into Phase 3 trials?
Added By: camawhinneyIn your opinion, do you see omecamtiv mecarbil continuing on into Phase 3 trials or being discontinued?
Added By: camawhinneyEven if it does continue being developed, do you think omecamtiv mecarbil has a chance to be approved by regulatory agencies?
Added By: camawhinneyIs the lack of studies showing an efficacy for treating patients the primary concern for the continuation of the development of omecamtiv mecarbil?
Added By: camawhinneyAre You Interested In These Questions?
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- Development of Omecamtiv Mecarbil Questionable to Continue to Phase 3 - Decision Expected This Year CYTK, AMGN Occurred On: Sep 01, 2016
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