Stealth BioTherapeutics has released encouraging results regarding their PREVIEW study, which demonstrated the capability of the investigational drug Bendavia to improve cardiac function. The research outcomes were presented during a symposium focused on the contribution of mitochondria for chronic heart failure, which took place at the European Society of Cardiology (ESC) Heart Failure Congress in Seville, Spain.
The single-dose, double-blind, placebo-controlled PREVIEW study included 36 patients who suffer from chronic heart failure in order to understand the safety, tolerability and efficacy of Bendavia, a novel formulation meant to target mitochondrial dysfunction and treat both common and rare conditions. Currently, treatments for chronic heart failure are able to decrease heart rate and blood pressure, but do not treat the underlying energy abnormality associated with mitochondrial dysfunction.
“Bendavia may be the new paradigm, restoring energy to the failing heart, rather than lowering heart rate and blood pressure,” believes the director of the Division of Cardiovascular Medicine and professor at Ohio State University, William Abraham, who described the clinical benefits of Bendavia for patients with cardiac and renal diseases at the symposium.
Participants in the study were previously being treated with standard medication, such as beta-blockers, diuretics and hypertension therapies, and were randomly administered 20 or 80 mg doses of Bendavia or placebo in ascending, weight-adjusted, single-dose cohorts. The Stealth investigators revealed that the primary safety and tolerability endpoints were met in all dosages, with linear pharmacokinetics across cohorts.
“The improved cardiac function shown in PREVIEW demonstrates Bendavia’s potential for patients,” stated in a press release the former president of the ESC Heart Failure Association and professor of Cardiology at University Medical Center Göttingen, Stefan Anker. “These results reinforce the promise of Bendavia — to both complement and improve traditional heart failure care.”
In addition, the researchers also evaluated secondary endpoints, such as cardiac function, assessed through echocardiography or alterations in chronic heart failure biomarkers. According to their conclusions, Bendavia was able to improve cardiac function, in comparison to placebo, cardiac output and stroke volume, as well as to decrease mean end-systolic and end-diastolic volume over 24 hours in the highest dose cohort.
“Bendavia’s improvement on cardiac function in both our PREVIEW and EMBRACE trials underscores its potential in heart failure,” added the CEO of Stealth BioTherapeutics, Travis Wilson. “We continue to broaden our cardio-renal program, initiating trials later this year to study Bendavia’s benefits in this underserved patient population.”
In addition to Abraham, Gerasimos Filippatos, the president of the ESC Heart Failure Association, was also at the event to lead the symposium on mitochondria in CHF, a panel that included John Cleland, Piotr Ponikowski and Hani Sabbah who discussed both the potential of Bendavia for the treatment of cardio and renal medical conditions and plans for further clinical trials involving the investigational drug.
Stealth also recently announced that they will expand their ophthalmology program, with the FDA granting a Type B meeting for genetic optic neuropathies, which are common to more than 20 congenital mitochondrial diseases and affect 1 in every 10,000 individuals. With the expansion of Ocuvia, the company is still committed to developing strategies for patients suffering from mitochondrial diseases.
Currently, there are no FDA approved drugs to treat patients with these conditions, and often treatments are limited to supplements and vitamins. The company is actively recruiting patients for its MMPOWER clinical trial with Bendavia. The trial is a multicenter study that is evaluating Bendavia for the treatment of patients with Mitochondrial Myopathy (MM) with genetic mitochondrial diseases.