Juventas Therapeutics announced today that the company has completed enrolment of the STOP-HF trial. STOP-HF is a double-blinded, placebo-controlled, multi-centre trial of its non-viral DNA plasmid therapy JVS-100 for patients with symptomatic heart failure.
A total of 93 patients have been enrolled in this trial at 16 academic and community hospitals throughout the USA.
Patients enrolled in STOP-HF had a prior history of a heart attack and years later developed symptomatic heart failure as defined by an ejection fraction less than 40% and poor quality of life and exercise tolerance as measured by the Minnesota Living with Heart Failure Questionnaire (MLWHQ) and six minute walk distance (6MWD), respectively.
Patients were randomised to placebo or treatment with two different doses of JVS-100. Therapy was directly delivered to the heart via endo-ventricular injection using the BioCardia Helical Infusion Catheter. In addition to safety, data for several efficacy endpoints is being collected at four months and one-year post-treatment including heart failure related hospitalisations, major adverse cardiac events, and changes in 6MWD, MLWHQ scores, and ejection fraction.
“The patients studied in this trial, on average, have experienced their most recent heart attack nearly a decade prior to treatment and their heart failure symptoms have progressed to a point that their health and ability to perform the activities of daily living are significantly deteriorating despite receiving optimal medical management,” states Marc Penn, chief Medical Officer for Juventas and Director of Research, Summa Cardiovascular Institute at Summa Health Systems. “The goal of STOP-HF is to further define the safety and clinical benefits of JVS-100 in heart failure patients who are already receiving the current standard of care.”
Earlier this year, Juventas Therapeutics completed enrolment of STOP-CLI, a phase IIa first-in-human, double-blinded, placebo-controlled, dose-escalation trial of JVS-100 for patients with Rutherford class 4 or 5 critical limb ischaemia. The 48-person trial enrolled critical limb ischaemia patients considered poor candidates for revascularisation at four centres in the USA and two centre in India. The primary endpoint for the trial will be safety with efficacy data collected on several key endpoints including amputation rates, Rutherford class, wound closure, and pain management.
“Completing enrolment of STOP-CLI and STOP-HF are significant milestones for the company this year,” states Rahul Aras, president and CEO for Juventas Therapeutics. “To date, more than 120 patients have received JVS-100 therapy and we are building a strong safety profile. Next year is an important year for Juventas, with efficacy data results targeted from both Phase II studies and additional trials scheduled to enrol. We are excited to transition JVS-100 into late stage clinical trials and commercialisation.”