Shares of Altimmune tumbled 55% Tuesday after the company released mid-stage data on its obesity drug, pemvidutide, which showed a 10% reduction in patients’ weight. The results, however, were overshadowed by safety concerns about the drug.
Pemvidutide is an innovative, peptide-based dual receptor agonist being studied as a potential treatment for obesity and non-alcoholic steatohepatitis (NASH). This promising compound works by activating both GLP-1 and glucagon receptors, offering the potential for a more comprehensive approach to managing these serious health conditions.
Researchers recently conducted a Phase II trial of 160 individuals with obesity, as well as a Phase Ib safety trial of 54 individuals with obesity and type 2 diabetes, to gain a better understanding of the effects of the disease. The results of these trials provide new insights into the management and treatment of these conditions.
At week 24, half of patients lost an average of 10% of their body weight, while one in five achieved an impressive 15% reduction in weight.
Altimmune encountered challenges during Phase II safety data collection for pemvidutide. 24% of patients discontinued treatment, with GI adverse events being the main reason for withdrawal in approximately half of the cases. These events occurred primarily within the first 16 weeks of treatment.
An unfortunate side effect of the 2.4 mg dose was experienced by one patient – nausea and vomiting, requiring rehydration. Despite these dose-related symptoms, the study protocol did not allow for any dose reduction due to the severity of the side effects.
Adverse events in the trials of pemvidutide were similar to those seen in previous studies, according to Altimmune.
Scott Harris, chief medical officer of Altimmune, declared in a conference call on Tuesday that the possibility of discontinuation due to adverse events could be reduced through lower doses of pemvidutide. He believes that this could be a viable solution to this pressing issue.
The market reacted swiftly and harshly to news of Altimmune’s clinical trial results, with the company’s shares plunging a dramatic 55% to $4.95 from Monday’s close of $10.92. This sharp decline came as a shock to investors, who had been eagerly awaiting the outcome of the trial.
Mayank Mamtani, B. Riley Securities’ managing director and group head of healthcare research, has opined that biotech markets can often be overly volatile, subject to extreme reactions.
Altimmune was overly confident in its study design, failing to include the ability to lower the dose in the event of side effects. However, the company looks to be on track to find an optimal dosing regimen.
Competitive Profile
Pemvidutide is set to become a major player in the obesity market, offering stiff competition to the likes of Novo Nordisk’s Wegovy and Eli Lilly’s soon-to-be-approved Mounjaro (tirzepatide). With the potential to bring in billions of dollars in revenue, Pemvidutide stands to be a major force to be reckoned with.
Patients taking either Wegovy or tirzepatide should be aware of the potential gastrointestinal issues that have been reported with both treatments. From nausea to abdominal discomfort, it’s important to be aware of the side effects that could arise from these medications. However, with proper medical advice and monitoring, these side effects can be managed to ensure the best outcome for your health.
In January 2021, the FDA made history by approving Wegovy, the first new drug for chronic weight management since 2014. Fast-forward to May 2022, and Lilly’s Mounjaro was given FDA approval for type 2 diabetes, further revolutionizing the way we manage our health.
The issue with both Wegovy and Mounjaro is that they require specialist management due to the intricate process of titration needed for a successful prescription. Without careful monitoring and adjustment, these medications may not be as effective as desired.
Altimmune faces a potential challenge in funding another mid-stage study to address safety concerns, yet the drug pemvidutide could be uniquely positioned in the market due to its ability to address NASH without causing hyperglycemia. This could be an advantageous factor for Altimmune in the long run.