Week in Review: Obesity Drug Race, Ipsen Therapy Finally Gets Approval and More
18 Aug 2023
Clinical ResultDrug ApprovalPhase 3Phase 2Accelerated Approval
Pictured: A scale and tape measure_iStock, Tatiana Sviridova
Just when you thought the weight-loss drug race couldn’t get any hotter, Boehringer Ingelheim this week announced it is taking its obesity drug candidate survodutide—with partner Zealand Pharma—into three global Phase III trials later this year. The news comes on the heels of Phase II data for survodutide which showed up to 19% weight loss in people who were overweight or obese.
In addition to being at least as effective as the competition, what differentiates survodutide from Novo Nordisk’s Ozempic and Wegovy and Eli Lilly’s Mounjaro is that Boehringer-Zealand’s dual agonist works against both glucagon receptors in the liver and GLP-1 to suppress appetite—which seemed to improve energy expenditure in the Phase II study, the companies said. Details of the planned Phase III studies will be disclosed prior to their launch with patient enrollment anticipated by the end of 2023, according to Boehringer. Game on!
We saw the tail-end of earnings season this week. As part of its Q2 report, Selecta Biosciences said it is halting further investments in its pipeline and will focus efforts on a candidate treatment for gout. The latest cost-reduction initiative is expected to extend Selecta’s cash runway into 2027. In May, the company announced a 25% workforce cut that only projected cash flow to the second half of 2025.
The FDA this week granted accelerated approval to Pfizer’s bispecific antibody elranatamab, to be marketed as Elrexfio, for the treatment of relapsed or refractory multiple myeloma (RRMM). It comes on the heels of J&J’s win last week in which the regulator granted accelerated approval for its first-in-class bispecific T cell engager Talvey as a treatment for RRMM.
In a highly anticipated regulatory decision this week, the FDA finally—after two prior setbacks for the company—approved Ipsen’s palovarotene to treat fibrodysplasia ossificans progressiva. It’s the first treatment in the U.S. for the extremely rare and degenerative condition that causes muscle and connective tissue to turn into bone. Other FDA approvals this week included Delcath Systems’ Hepzato Kit for the liver-directed treatment of adult patients with metastatic uveal melanoma and Revance Therapeutics’ Daxxify for the treatment of cervical dystonia in adults.
In a regulatory preview of sorts this week, BioSpace took a look at 10 late-stage neuropsychiatric drugs nearing FDA review. Senior Editor Heather McKenzie points out that the most highly anticipated treatments have one thing in common: they’re first-in-class.
There was also big news this week regarding Chimerix’s first in-class small molecule imipridone, which reported positive results from two early-stage clinical trials studying a potential treatment for an incurable and aggressive type of pediatric brain tumor. In the studies, the Chimerix candidate ONC201 nearly doubled survival for patients with H3K27M-mutated diffuse midline gliomas.
Greg Slabodkin is the News Editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.
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