Considering NASH drug development has stumped companies big and small, can newcomer Rivus Pharmaceuticals move the needle?
The Charlottesville, Va.-based company hopes so and is out today with data on its lead candidate showing a reduction in liver fat, a key hallmark of NASH, or non-alcoholic steatohepatitis. The results also provided some evidence that suggests improvements in metabolic parameters related to Type 2 diabetes, a type of heart failure and the tricky liver disease NASH.
The drug prospect, called HU6, met the primary endpoint of reducing liver fat in a phase 2a study of patients who were obese with elevated liver fat. Secondary goals included different measures of fat loss. The endpoints were achieved while conserving skeletal muscle mass. Patients also saw improvements in markers of insulin resistance and inflammation, according to Rivus.
The company believes that HU6 could help address the root causes of metabolic diseases by reducing liver fat, especially since the results occurred in a relatively short timeframe of eight weeks.
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Rivus said that the therapy achieved reductions in liver fat ranging from 33% to 40% depending on the dose. Participants lost an average of six pounds during the study, but participants who had elevated blood glucose saw even greater reductions in weight and fat. These patients lost an average of 10 pounds.
As for safety, HU6 was well tolerated with no serious adverse events recorded. One patient in the low-dose group discontinued due to diarrhea, but no discontinuations were seen in the high-dose group.
With the results in hand, the company can now consider whether reducing visceral and organ fat can benefit patients with cardiometabolic diseases, Rivus’ Chief Scientific Officer Shaharyar Khan, Ph.D., said.
The biotech plans to continue with the HU6 clinical program through the first half of the year, including a phase 2a study in heart failure with preserved ejection fracture. A phase 2b study in type 2 diabetes and NASH will come next.
NASH has stymied some of the top drugmakers in the world. Bristol Myers Squibb in November shelved a midstage asset in the disease after lackluster results. But Big Pharma still wants in on this potentially lucrative market. GlaxoSmithKline just put up to $1 billion on the line in a pact with Arrowhead Pharmaceuticals to develop the NASH candidate ARO-HSD.
A couple of small biotechs have kept the lights on in NASH. Madrigal and 89bio both reported some success with their candidates in January. To join that group, Rivus will need to see that phase 2b through.
Rivus emerged in July of last year with a $35 million series A to tackle a host of metabolic disorders.