Rivus Pharmaceuticals Announces Riveting Clinical Data for Their Unique Fat-Burning Therapeutic

Rivus Pharmaceuticals has made exciting strides since their initial founding in 2019, including an impressive $35 million Series A launch in July 2021. Today the Charlottesville-based company adds yet another feather to their cap with the announcement of positive clinical data for their lead candidate, HU6.

The results come from a randomized, double-blind, placebo-controlled Phase 2a trial evaluating how HU6 performs in obese patients with elevated liver fat. In an eight week period, participants saw significant reductions in liver, visceral, and total body fat while skeletal muscle mass was spared. Importantly, HU6 was also well-tolerated at all dose levels, with most adverse events being mild.

“We’re very excited to not only achieve our primary endpoint, but also multiple secondary endpoints in the span of just eight weeks,” said Shaharyar Khan, Ph.D., Rivus CSO in an interview with BioBuzz. “Also importantly, patients aren’t losing weight too quickly. We’re in the bounds of safe weight loss.”

HU6 – A Unique Controlled Metabolic Accelerator

The team’s inspiration for starting the company stemmed from a very simple question – where does the fat actually go when you lose weight, and how can we tap into that mechanism using small molecules?

Not surprisingly, the mitochondria play a major role. Sugars and fats are naturally broken down by several biochemical processes – namely glycolysis, the Krebs cycle, and beta oxidation. In the process, protons are shuffled around the various mitochondrial membranes. These proton gradients play an important role in regulating the overall metabolic process.

Rivus’s controlled metabolic accelerators (CMAs), including HU6, ferry the protons out of the intermembrane space, sending cues to the mitochondria to continue breaking down existing fat and sugar reserves. Notably, the CMAs work without the need for suppressing appetite.

Other approaches out there often target caloric intake, with the weight loss occurring from loss of skeletal muscle.

“We wanted to shift the equation from focusing on caloric deficits to caloric expenditure,” said Allen Cunningham, Rivus CEO.

How Rivus’s Controlled Metabolic Accelerators Work to Increase Fat and Sugar Breakdown (Source: Rivus Pharmaceuticals)

Rivus is the first company who has introduced this mechanism into the clinic, and they’re not stopping at HU6. The company also has other controlled metabolic accelerators in their arsenal that are in development, with the potential to go after a myriad of additional indications.

This year the company plans to continue evaluating HU6 in heart failure with preserved ejection fracture, followed by Phase 2b studies in type 2 diabetes and non-alcoholic steatohepatitis (NASH).

“In developing these molecules, we’ve been learning a lot about how to make this pharmacology druggable. We’re seeing exciting results from these trials that we haven’t seen before,” said Khan. “We’ve seen that HU6 can selectively reduce visceral fat. Now, the question we’re looking to answer is whether this selective reduction provides therapeutic benefit in different diseases.”

Not Just Another Weight Loss Pill

HU6’s promise goes much deeper than just weight loss itself.

By selectively targeting visceral fat rather than skeletal muscle, as other weight loss therapies often do, HU6 is poised to make weight loss more obtainable for those who don’t have skeletal muscle to spar, such as an elderly individual with type 2 diabetes.

Another notable highlight from the data shows that individuals with high HbA1c levels, whom often have a harder time losing weight, actually saw the greatest reductions in weight and body fat in the study.

And, to add the cherry on top, HU6 is administered as a once-daily oral tablet rather than an injectable – an option that is always more appealing to patients.

Another Node in Charlottesville’s Budding Biotech Ecosystem

The Rivus team is no stranger to the Charlottesville area, which has seen incredible growth in its life science sector in recent years. Prior to Rivus, the core leadership team held various roles at Gencia Biotech, which was also based out of Charlottesville.

“Almost all of our team members have some affiliation with the University of Virginia, myself included,” said Cunningham. “The area is definitely a burgeoning community, with lots of resources to support biotech companies.”

And with the positive data and continued expansion of their clinical trial programs, Rivus is looking to grow their team in the near future. Those who are interested in potential exciting career opportunities should reach out to info@rivuspharma.com for more info.