Rivus Pharmaceuticals has reported positive data from single and multiple ascending dose segments of the Phase I clinical trial of its oral therapy, HU6.
HU6 is a controlled metabolic accelerator (CMA) treatment given orally.
CMAs can potentially enhance cellular metabolism and cure underlying reasons of poor metabolic health and cardiovascular disease by leveraging the natural processes of the body.
The HU6 Phase I programme had a double-blind, randomised, placebo-controlled single ascending dose (SAD) and multiple ascending dose (MAD) trial.
The SAD part enrolled 50 healthy subjects to receive doses of HU6 ranging from 30-1,400mg.
A total of 24 participants with a high body mass index (BMI) of 35kg/m²-45kg/m² were part of the MAD segment. These volunteers were given 200mg, 400mg and 550mg doses of the drug once daily for 14 days.
Findings showed that the HU6 treatment showed a rise in expenditure of resting energy, as well as a dose-based weight reduction and progress in metabolic parameters.
The oral therapy offered a strong and long-lasting target engagement without any clear safety signals.
Furthermore, it was well-tolerated at all the dose levels tested in the trial with the limit to tolerability not attained for these doses.
Lasting effects on crucial biological parameters related to cardiometabolic diseases, including type 2 diabetes, non-alcoholic steatohepatitis, heart failure with preserved ejection fracture and severe hypertriglyceridemia were reported.
Rivus Pharmaceuticals president and CEO Allen Cunningham said: “We are highly encouraged by Phase I clinical trial results for HU6, which demonstrate a compelling, positive impact on multiple key indicators of cardiometabolic disorders.
“The data overwhelmingly support the continued development of HU6 to deliver novel and effective treatment to the million people who live with poor metabolic health and cardiovascular disease.”
The company concluded subject enrolment in a randomised, placebo-controlled, double-blind Phase IIa clinical trial of HU6 in arms of subjects with BMI between 28kg/m² and 45kg/m².
Topline results from the trial are anticipated in the first quarter of next year.