MET-097i’s mid-stage performance “bodes well” for Pfizer’s proposed buyout of Metsera, according to BMO Capital Markets, a deal centered heavily on the investigational GLP-1 drug.
Metsera’s investigational long-acting GLP-1 therapy MET-097i elicited 14% placebo-adjusted weight reduction in a mid-stage study, paving the way for a late-stage program to begin later this year.
All told, Metsera’s readout on Monday “bodes well for the proposed acquisition . . . by Pfizer,” analysts at BMO Capital Markets said in a note to investors. “This early look gives credence not only to the Metsera asset, but also the internal due diligence in sourcing the deal.”
Pfizer last week announced that it would acquire Metsera for $4.9 billion. MET-097i, a once-monthly subcutaneous injection, is one of the two centerpieces of the buyout, being the backbone asset for the biotech’s obesity strategy.
The Phase IIb VESPER-1 trial’s findings are “very encouraging,” analysts at Leerink Partners told investors on Tuesday morning, noting that, in comparison, Eli Lilly’s blockbuster drug tirzepatide “achieved about a 13% placebo-adjusted weight-loss” after the same follow-up duration.
A 1.2-mg dose of MET-097i cut body weight by 14.1% versus placebo at 28 weeks, with some individual responses reaching as high as 26.5%, according to a Monday release from Metsera. The biotech also conducted an exploratory analysis and found “substantial continued weight loss” at 36 weeks, which, according to Leerink, indicates that “no plateau had been reached.”
Alongside efficacy data in VESPER-1, Metsera on Monday also unveiled tolerability findings from another Phase IIb study, dubbed VESPER-3. Over 12 weeks of follow-up, the placebo-adjusted risk of nausea across all four MET-097i dose arms—corresponding to various strengths and titration schedules—ranged from 12.8% to 23.9%.
Meanwhile, diarrhea risk ranged from 0% to 11%, and vomiting risk ranged from 9.2% to 17%.
According to Leerink, VESPER-3’s safety findings point to the “promise for the tolerability profile of MET-097i to be better than tirzepatide in SURMOUNT-1.” The analysts pointed out, however, that Lilly’s SURMOUNT-1 followed patients for 72 weeks and therefore had “more time for [adverse events] to accrue.” VESPER-3 is ongoing, with topline data expected by year-end or early next year.
Aside from testing the drug as a weight-loss monotherapy, Metsera is also testing MET-097i in combination with an amylin analog and with a GIP receptor agonist. The company is also working on an oral formulation of MET-097i, as well as on a prodrug version for maintenance dosing.
