Boehringer Ingelheim has recently announced promising Phase II clinical trial results for its experimental drug,
survodutide, which is being developed to treat
metabolic dysfunction-associated steatohepatitis (MASH). The drug, a dual agonist targeting both the
glucagon and
GLP-1 receptors, has shown a significant impact on improving the condition of patients with MASH.
In the 48-week study, a remarkable 83% of participants who received survodutide experienced a notable improvement in their liver health, as confirmed by biopsy, without any progression in their fibrosis stages. This was the primary goal of the study. In contrast, only 18.2% of those on a placebo achieved the same level of improvement. The difference in response rate, at 64.8%, was statistically significant, with a p-value of less than 0.0001.
Furthermore, survodutide was successful in achieving its secondary objectives, which included a reduction in
liver fibrosis and a decrease in liver fat content. These improvements were measured using a specialized magnetic resonance imaging technique.
Boehringer Ingelheim plans to present a full report and detailed analysis of the trial's results in the coming months. The company's head of human pharmaceuticals, Carinne Brouillon, has expressed confidence in survodutide's potential as a leading treatment option. She highlighted the unique action of the glucagon receptor agonism, which directly affects the liver, as a key differentiator for the drug.
Survodutide was co-developed with
Zealand Pharma and is an innovative treatment that simultaneously activates two key gut hormone receptors, potentially offering higher efficacy than existing single-hormone treatments. Under their partnership agreement,
Boehringer Ingelheim is responsible for all R&D and commercialization efforts, while Zealand Pharma is eligible for certain milestones and royalties on global sales.
Beyond the treatment of MASH, survodutide is also being studied in Phase III trials for its potential to aid individuals who are overweight or have obesity. Boehringer Ingelheim initiated three such studies in May 2023, aiming to evaluate the drug's effectiveness in various sub-populations, including those with
diabetes,
cardiovascular diseases, and
chronic kidney disease.
In June 2023, preliminary Phase II data indicated that survodutide could lead to a reduction in body weight by approximately 20%. Notably, the weight loss had not yet reached a plateau at 46 weeks, suggesting that extended treatment could yield even better results.
The ongoing research and development of survodutide underscore the pharmaceutical industry's commitment to addressing
complex metabolic disorders and
obesity, offering hope for improved treatments and outcomes for affected individuals.
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