Tenax Therapeutics plans to advance its lead compound, levosimendan, into a Phase 2 clinical trial to treat pulmonary hypertension (PH) associated with heart failure and preserved ejection fraction (PH-HFpEF) — a type of PH related to left heart disease.
The company, based in Morrisville, North Carolina, aims to start the clinical trial in late 2018, prompted by the positive feedback of clinical experts on PH and promising preliminary studies of the compound in PH-HFpEF patients.
Fewer than half of the 1.5 million Americans believed to have PH-HFpEF survive more than five years. No treatment is available for this disease, which encouraged Tenax to invest in a therapy for the illness.
Tenax owns the U.S. rights to commercialize and develop levosimendan, and recently completed a Phase 3 clinical trial for a levosimendan-based medicine, LEVO-CTS, to improve clinical outcomes in patients who undergo cardiac surgery.
The company now hopes to speed clinical development of levosimendan as a therapy for PH-HFpEF, and already asked the FDA for pre-investigational drug approval.
“Our advisors’ strong support for this development plan, combined with the significant commercial value that it could represent, makes us very excited to execute this new clinical development strategy.” said Tenax’s interim CEO, Michael Jebsen.