FORTITUDE-ALS did not attain statistical importance in its primary endpoint of change from baseline in SVC

Patients who received reldesemtiv in FORTITUDE-ALS exhibited lesser decline than the patients who received placebo

Cytokinetics has reportedly announced the results of FORTITUDE-ALS, a Phase 2 clinical study of the drug reldesemtiv in patients with a neurodegenerative disease called amyotrophic lateral sclerosis, or ALS, presented by Jeremy Shefner (Ph.D, M.D), a Lead Investigator of FORTITUDE-ALS.

It was formally presented on 5 May 2019 during a presentation at the Annual Meeting of American Academy of Neurology in Philadelphia.

Sources familiar with the matter stated that for a pre-specified dosage-response relationship, FORTITUDE-ALS did not attain statistical importance in its primary endpoint of change from baseline in SVC after 12 weeks of treatment.

Apparently, similar ALSFRS-R studies and slope of the Muscle Strength Mega-Score yielded lower p-values. However, patients on all treatment groups of reldesemtiv showed less decline than patients on placebo for ALSFRS-R and SVC (slow vital capacity), with clinically meaningful differences developing over time.    

Seemingly, for the primary and secondary endpoints the dose-response analyses did not achieve statistical significance at the level of 0.05, in a post-hoc analysis combining the doses altogether and finding that patients who received reldesemtiv in FORTITUDE-ALS exhibit lesser decline than the patients who received placebo. The clinical trial presented effects favouring reldesemtiv across dosage levels and timepoints observed at 12 weeks for the primary and secondary endpoints.

The differences between placebo and reldesemtiv in SVC and ALSFRS-R total score noticed after 12 weeks of clinical treatment were still apparent at continuation, four weeks after the last dose of trial drug, sources said.

According to Dr. Shefner, results from FORTITUDE-ALS are considered the most inspiring in a Phase 2 clinical trial in ALS. Supposedly, Cytokinetics is teaming up with Astellas for the development of reldesemtiv, a future-generation FSTA, defined as fast skeletal muscle troponin activator, as a potential treatment for people living with conditions and diseases related with skeletal muscle weakness or fatigue.

Source Credit: https://www.globenewswire.com/news-release/2019/05/05/1817143/0/en/Cytokinetics-Announces-Results-of-FORTITUDE-ALS-a-Phase-2-Clinical-Trial-of-Reldesemtiv-in-Patients-With-ALS-Presented-at-American-Academy-of-Neurology-Annual-Meeting.html

http://ir.cytokinetics.com/news-releases/news-release-details/cytokinetics-announces-results-fortitude-als-phase-2-clinical