FDA grants Fast Track designation to Juventas' JVS-100 drug candidate and allows Phase 2b clinical trial

Jun 16 2015

Juventas Therapeutics, Inc., a clinical-stage biotechnology company developing novel non-viral gene therapies that activate natural processes to repair the body, today announced that its product candidate, JVS-100, received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the treatment of advanced ischemic chronic heart failure. The FDA Fast Track process is designed to expedite the development and review of drugs to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. The FDA has also allowed the protocol for the company's Phase 2b double-blinded, randomized clinical trial of JVS-100 for the treatment of advanced ischemic chronic heart failure in patients with a prior history of heart attack, referred to as STOP-HF2.

"The Fast Track designation by the FDA is intended to facilitate the development of drug candidates like JVS-100," stated Eugene Chung, M.D., FACC, director of heart failure, Ohio Heart and Vascular Center. "The patients we will be treating have advanced ischemic chronic heart failure that is being managed with optimal guideline-based therapy. In many cases, the next therapeutic option involves implantation of a left ventricular assist device (LVAD) or heart transplant. JVS-100 may provide a viable therapy for these patients that currently have no other non-surgical options."

The STOP-HF2 trial is expected to enroll up to 180 patients at as many as 40 clinical centers in a double-blinded, 1:1 randomized, sham-controlled study evaluating the impact of two administrations of 30 mg doses of JVS-100 in heart failure patients with low ejection fraction (less than or equal to 35%) and elevated serum biomarkers (NTproBNP greater than or equal to 500 pg/mL). The first dose will be delivered at the time of patient enrollment and the second will be delivered six months later, each by endomyocardial injection catheter to the left ventricle of the heart.

"We are excited to initiate STOP-HF2, which will continue our evaluation of JVS-100's potential to provide clinical benefit to patients with advanced ischemic chronic heart failure," stated Marc Penn, M.D., Ph.D., FACC, co-founder of Juventas and director of cardiovascular research at Summa Health. "Juventas recently reported that a pre-specified sub-analysis of patients with severe heart failure in our exploratory Phase 2 trial demonstrated that a single administration of JVS-100 improved cardiac function, structure, serum biomarkers and clinical status for at least one year post treatment. STOP-HF2 will look to confirm those findings in a larger, prospectively designed clinical study. In addition, STOP-HF2 will evaluate whether repeat administration of JVS-100 six months following initial administration can enhance and prolong therapeutic benefits. The results of this study will help guide the design of our pivotal Phase 3 registration trials for JVS-100."

SOURCE Juventas Therapeutics