Rivus Pharmaceuticals’ obesity treatment for patients with heart failure spurred a 6.3-pound drop in weight compared to placebo after three months of treatment, said the startup, which plans to use the positive result to raise more money.
Monday’s results, which were statistically significant (p=0.003), expand on an interim readout from August, when the company said its oral weight loss treatment HU6 was effective in patients with obesity who have heart failure with preserved ejection fraction (HFpEF) but didn’t give a numerical weight loss figure.
The RA-backed obesity biotech had planned to present that data at the Heart Failure Society of America annual meeting in Atlanta, but it was canceled due to Hurricane Helene.
It also provided a weight loss figure compared to baseline of 6.8 pounds, which was similar to the placebo comparison. Average starting weight for patients was 245 pounds.
The drug was also found to spur significant reductions over placebo in fat mass loss, visceral fat loss, and systolic and diastolic blood pressure, among other secondary endpoints. Rivus said there was no significant reduction in lean body mass compared to placebo, an intriguing result that will raise hopes the drug won’t shrink useful muscle.
Jayson DallasRivus plans to use the data to raise more cash, CEO Jayson Dallas said in an interview with Endpoints News.
“I think we probably will do something, whatever that is, by the end of the year,” Dallas said. He didn’t specify whether the company was planning for another private raise or an initial public offering. The Charlottesville, VA-based company raised a $132 million Series B two years ago.
The new capital will go toward the company’s mid- to late-stage development effort, with plans to head to the FDA in early 2025 for guidance on a Phase 3 program that will launch around the middle of the year. Dallas said he and Rivus are also waiting to see more data on Lilly’s tirzepatide in the same patient population, which had a positive Phase 3 readout in August.
Lilly reported at the time that tirzepatide spurred a 38% reduction in heart failure outcomes compared with placebo, and a 15.7% drop in body weight when calculated prior to study discontinuations. Dallas believes that Rivus’ encouraging muscle retention data will be a differentiator, especially given the HFpEF patient population is older and frailer than the wider obesity population.
The company also reported a relatively clean safety profile, with the most common treatment-emergent side effects being diarrhea, Covid-19 and shortness of breath. Notably missing were high cases of vomiting and nausea, one of the drags on the current class of GLP-1 drugs. Rivus also reported no treatment-related serious adverse events.
The company also expects to have data soon on another Phase 2 study testing HU6 in patients with MASH. The study is fully enrolled and initial data are expected around the second quarter of next year.
“That’s kind of the trigger for next steps,” Dallas said. “If we see at the end of six months that indeed, our weight loss is linear and there’s no plateau, which is what we expect, that’s actually hugely advantageous versus the incretins.”