Imbria Pharmaceuticals has randomised the first participant in FORTITUDE HCM, a Phase IIb trial of ninerafaxstat in symptomatic non-obstructive hypertrophic cardiomyopathy (nHCM), a condition for which no approved treatments currently exist.
The multi-centre, globally conducted, placebo-controlled, double-blind, parallel-group study is enrolling nearly 165 subjects diagnosed with nHCM.
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Subjects will be administered either ninerafaxstat at a dosage of 200mg twice daily or a placebo.
The primary objective of the study is to assess the change from baseline in the Kansas City Cardiomyopathy Questionnaire – Clinical Summary Score (KCCQ-CSS).
Secondary goals include evaluating changes in the overall summary scores and components of the KCCQ-CSS, as well as measuring ventilatory efficiency during standardised cardiopulmonary exercise testing.
Lahey Hospital and Medical Center Hypertrophic Cardiomyopathy Center director Martin Maron is serving as the trial’s principal investigator.
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By GlobalDataImbria chief medical officer Albert Kim said: “Randomising the first patient in FORTITUDE‑HCM represents a significant step forward in our mission to bring innovative therapies to patients with nHCM. These patients face a substantial disease burden with limited treatment options.
“Building on ninerafaxstat’s strong mechanistic rationale and prior clinical data, this trial is designed to evaluate whether improving cardiac energetics can deliver meaningful benefits for patients.”
Enrolment is presently in progress at various locations throughout the US, with further sites in both the UK and US projected to open shortly. The activation of sites within the EU is expected to begin in early 2026.
In June 2023, Imbria completed subject enrolment in its IMPROVE-HCM Phase II clinical trial of ninerafaxstat for nHCM.
