Upcoming MASH Treatments Post-Rezdiffra Approval

Madrigal Pharmaceuticals has recently gained approval for Rezdiffra, the first treatment for metabolic dysfunction-associated steatohepatitis (MASH), a liver condition characterized by inflammation due to excessive fat. Despite this milestone, there is a general agreement in the medical community that further advancements are necessary, as only a portion of patients experience fibrosis improvement with Rezdiffra.

MASH is a serious health issue that can escalate to fibrosis and liver cirrhosis. Lawrence Blatt, CEO of Aligos Therapeutics, which is also working on a MASH treatment, acknowledges the significance of Rezdiffra's approval but points out that there is substantial room for improvement, given that only about 25% of patients see fibrosis reversal.

In the pharmaceutical landscape, other companies are also making strides in MASH treatment. Ionis Pharmaceuticals reported positive results from its Phase II trial of a MASH drug candidate, demonstrating significant improvements without fibrosis exacerbation. BioSpace examines five other investigational drugs in mid to late stages of development for MASH.

Ionis's drug, ION224, has shown promising results in Phase II trials, with a notable percentage of participants experiencing at least a one-stage fibrosis improvement. The drug targets the DGAT2 enzyme, associated with fatty liver disease, and has been well-tolerated in trials.

Altimmune's Pemvidutide is a peptide-based drug entering Phase IIb trials. It acts as a dual receptor agonist for GLP-1 and glucagon, which can aid in weight loss and directly impact liver fat metabolism. Analysts are optimistic about this class of drugs, which have shown to lower liver fat and improve liver health beyond the effects of Rezdiffra.

89bio is developing pegozafermin, an FGF21 analog, which addresses the metabolic roots of liver and cardiometabolic diseases. The drug has shown positive results in a Phase IIb trial, particularly for patients with advanced stages of fibrosis.

Viking Therapeutics' VK2809, a thyroid hormone receptor beta agonist like Rezdiffra, is in Phase IIb trials and has demonstrated significant liver fat reduction. It has the potential to offer a more effective clinical profile than Rezdiffra.

Lastly, Aligos Therapeutics has initiated trials for ALG-055009, another THR-ß agonist. Early trials indicate it may be significantly more potent than Rezdiffra and offers a more predictable pharmacokinetic profile.

As the search for better MASH treatments continues, these developments signal a promising future for patients suffering from this challenging condition. The pharmaceutical industry's ongoing efforts aim to address the unmet needs of the majority of patients who do not sufficiently respond to current treatments.