Extremely anticipated Part 2 knowledge for Amgen’s weight problems drug present that on common, contributors misplaced about 20% of their weight after one yr of remedy, outcomes that put the experimental medication within the ballpark of blockbuster Eli Lilly product Zepbound.
Zepbound and Novo Nordisk’s Wegovy are each administered as weekly injections. Amgen’s drug, maridebart cafraglutide, or MariTide, was examined with doses administered month-to-month and even much less regularly. Within the consumer-driven weight problems drug market, some analysts say comparable weight reduction with the comfort of much less frequent dosing might make MariTide stand aside from peer injectable weight-loss medicines.
The load loss Amgen reported Tuesday didn’t plateau, which the corporate says point out the potential for even larger weight reduction with longer remedy. The pharmaceutical large plans to publish a fuller image of the Part 2 outcomes and current them at a future medical convention. However with the encouraging preliminary knowledge in hand, Amgen mentioned it’s making ready to advance MariTide to Part 3 testing.
Wegovy and Zepbound are each peptide medication designed to bind to and activate the GLP-1 receptors. Zepbound is designed to activate a second goal known as GIP. MariTide is a peptide antibody conjugate. Much like Zepbound, it provides a twin mechanism of motion by concentrating on each the GLP-1 and GIP receptors. However quite than activating GIP the way in which Zepbound does, MariTide blocks this receptor. Amgen additionally says its drug is designed with an extended half-life, which permits longer dosing intervals.
The Part 2 take a look at enrolled 592 adults who have been dwelling with weight problems or obese. 4 doses of the examine drug have been evaluated. The 20% common weight reduction was reported for the cohort who didn’t have diabetes. In examine contributors identified with sort 2 diabetes, the common weight reduction was 17%. In these diabetes sufferers, remedy with MariTide additionally led to a 2.2 proportion level discount, at 52 weeks, in hemoglobin A1C, a measure of blood sugar ranges.
On measures of security and tolerability, Amgen’s drug seems to be in step with its friends. Gastrointestinal issues have been essentially the most generally reported hostile occasions within the Part 2 examine. Amgen mentioned these issues have been categorized as delicate and transient, primarily related to the primary dose. Amgen famous that there was no affiliation between MariTide and modifications to bone mineral density, a priority that was raised earlier this month after the inadvertent disclosure of Part 1 knowledge from a spreadsheet recommended the drug led to bone density modifications.
The reported weight reductions for MariTide are larger than what was achieved in scientific trials of Novo Nordisk’s Wegovy and on par with Lilly’s Zepbound. However it’s price noting that Lilly can be creating a next-generation weight reduction drug known as retatrutide, a peptide engineered to hit three metabolic targets to spark weight reduction. In Part 2 outcomes reported final yr and printed in The New England Journal of Drugs, remedy with the drug for 48 weeks led to a median 24.2% discount in weight.
In a observe despatched to traders, William Blair analyst Matt Phipps mentioned the burden loss marks posted by MariTide are under market expectations, however the agency nonetheless sees potential for the drug. Whereas the addition of a decrease preliminary step-up dose resulted in charges of nausea and vomiting that seem increased than what has been reported with Zepbound and Wegovy, Phipps mentioned these hostile occasions are largely restricted to the primary dose, and the general severity or length of those issues seem just like the GLP-1 class. Due to this fact, MariTide’s potential to supply comparable efficacy and tolerability however with considerably longer dosing intervals nonetheless represents a blockbuster alternative.
“Total, we imagine MariTide continues to point out a differentiated profile versus at the moment authorised GLP-1 therapies or these in late-stage growth, largely because of the potential to be administered with considerably much less frequency,” Phipps mentioned. “We imagine this will likely be interesting in what is essentially changing into a consumer-driven market, and mixed with manufacturing benefits will lead to significant market share regardless of being a number of years behind in growth.”
However to Leerink Companions’ Thomas Smith, the failure of Amgen’s drug to point out differentiation removes a aggressive risk to Viking Therapeutics. Viking’s VK2735 additionally targets and prompts the GLP-1 and GIP receptors. Along with a weekly injectable formulation, Viking can be creating a once-daily oral model of the drug. The power to supply each injectable and oral formulations is the differentiator that Smith sees might make Viking’s drug greatest at school. Injectable VK2735 is at the moment in Part 3 testing. Viking reported encouraging Part 1 knowledge for the oral formulation earlier this month.
“We imagine the MariTide outcomes eliminated one of many aggressive knowledge overhangs for [Viking], and we proceed to see [subcutaneous] VK2735 as some of the promising GLP-1/GIP twin agonist compounds at the moment in growth primarily based on a sexy stability of efficacy and tolerability,” Smith wrote.
The MariTide outcomes at one yr are from half 1 of the Part 2 examine. Half 2 is evaluating additional weight reduction with continued remedy and the sturdiness of weight reduction after discontinuation of the drug. This second half can be evaluating weight upkeep with much less frequent or decrease dosing. Amgen mentioned greater than 90% of eligible sufferers from half 1 selected to proceed to half 2 of the examine.
Picture: Patrick T. Fallon/Bloomberg, through Getty Pictures
