Pemvidutide

What is Pemvidutide

Pemvidutide is a novel, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and non-alcoholic steatohepatitis (NASH). Pemvidutide incorporates the EuPortTM domain, a proprietary technology that increases the serum half-life of pemvidutide, allowing for weekly dosing, and may slow the entry of pemvidutide into the bloodstream for improved tolerability.  In clinical trials, pemvidutide not only demonstrated reductions in body weight but also significant reductions in liver fat content, serum lipids and markers of liver inflammation which together may potentially provide additional cardioprotective effects over those realized through weight loss alone.

For more information

Pemvidutide for the Treatment of Obesity

There are over 1 billion people worldwide with obesity10 and it carries with it an economic burden of $705 billion in the United States alone11 It is linked to conditions such as hypertension, cardiovascular complications, diabetes, dyslipidemia and non-alcoholic fatty liver disease (NAFLD). Given the prevalence of obesity comorbidities, there is a tremendous need for treatment optionality to address the obesity and directly impact the comorbidities.

Currently, our Phase 2 MOMENTUM 48-week clinical trial is evaluating the safety and efficacy of pemvidutide in subjects with obesity or overweight. An interim readout at 24 weeks demonstrated meaningful changes such as:

  • Robust reductions in body weight
  • Important reductions in serum lipids including total cholesterol and LDL-C
  • Improvements in blood pressure without meaningful changes in heart rate

For details on the 48-week trial results, click here.

Pemvidutide for the Treatment of NASH

It is estimated that ~80 million12 people in the United States have NAFLD. The excess liver fat that characterizes NAFLD can cause chronic inflammation often leading to fibrosis and eventually liver cirrhosis and increased risk for cardiovascular disease. There are currently no approved treatments for NASH.

Our Phase 2b IMPACT NASH trial is being conducted in approximately 190 subjects with and without diabetes.  The key endpoints will be NASH resolution and fibrosis improvement after 24 weeks of treatment, with subjects followed for an additional 24 weeks for assessment of safety and additional biomarker responses.

Results from a 24-week Phase 1b randomized, placebo-controlled study of pemvidutide in subjects with NAFLD showed:

  • Class-leading relative reductions in liver fat
  • ~55% of subjects had their liver fat content reduced to the normal range in just 12 weeks at the 1.8 mg dose
  • Significant reductions of alanine aminotransferase (ALT) and corrected T1 (cT1), two independent measures of liver inflammation
  • Meaningful weight loss in addition to the liver effects

IMPACT Phase 2b NASH trial top line data expected in Q1 2025.

Summary

Pemvidutide’s clinically-demonstrated combined capability to significantly reduce body weight, liver fat content and serum lipids is an unmatched profile relative to other obesity and NASH drugs and therapeutic candidates. Given this profile, pemvidutide, if approved, has the potential to be an important treatment option for patients with obesity, especially individuals with NAFLD/NASH or dyslipidemia or other related comorbidities.