Drugs

Altimmune Mixed Results for Pemvidutide in MASH

Altimmune is announcing mixed topline results today from its Phase 2b IMPACT trial evaluating pemvidutide in patients with metabolic dysfunction-associated steatohepatitis (MASH), a progressive liver disease. The study showed that pemvidutide led to significant improvements in disease resolution and weight loss, with promising signals of anti-fibrotic activity, according to the company.

However, the drug’s effects on fibrosis improvement without worsening of MASH were 31.8% and 34.5% for pemvidutide 1.2 mg and 1.8 mg, respectively, compared with 25.9% for placebo — differences that the company says were not statistically significant. But a supplemental AI-based analysis “demonstrated statistically significant reductions in fibrosis, including 30.6% of participants receiving pemvidutide 1.8 mg achieving a 60% or more reduction in fibrosis compared to 8.2% receiving placebo,” it says.

The 24-week study enrolled 212 patients with biopsy-confirmed MASH and moderate to advanced fibrosis (stages F2/F3), including those with and without diabetes. The company says participants were randomized to receive once-weekly subcutaneous injections of pemvidutide at either 1.2 mg or 1.8 mg, or a placebo. According to an intent-to-treat (ITT) analysis, 59.1% of patients receiving 1.2 mg and 52.1% receiving 1.8 mg of pemvidutide achieved resolution of MASH without worsening of fibrosis, it says. By contrast, only 19.1% of patients in the placebo group achieved the same outcome, a statistically significant difference.

Beyond liver outcomes, pemvidutide produced notable weight loss: 5.0% and 6.2% reductions in body weight in the 1.2 mg and 1.8 mg groups, respectively, compared with just 1.0% for placebo, Altimmune says. Liver fat levels also fell by 58.0% and 62.8% with pemvidutide, versus a 16.2% reduction in the placebo group.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

Read more

Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome