Today, a brief rundown of news involving Amgen and GenAssist, as well as updates from Novo Nordisk, Orbis Medicines and BioNTech you may have missed.
Amgen is starting up a pair of Phase 3 trials for its experimental obesity drug maridebart cafraglutide, or MariTide, according to a federal database. The company plans to enroll about 4,500 people who are overweight or obese in the two trials, with the smaller of the studies involving those who also have Type 2 diabetes. Both trials will test three different dose levels and compare MariTide’s weight-loss effects to a placebo after 72 weeks of treatment, though the specific regimens and dosing frequency weren’t yet revealed. MariTide is one of the more closely watched obesity drugs in clinical development because of its potential to be administered monthly, not weekly, like Novo Nordisk’sWegovy or Eli Lilly’sZepbound — Jonathan Gardner
Novo, meanwhile, announced on Wednesday the creation of a online pharmacy through which certain patients can order Wegovy at a discounted price if they pay in cash. Called NovoCare Pharmacy, the program offers all Wegovy doses at $499 a month and is available to people who’ve been prescribed Wegovy but aren’t insured or don’t have obesity drug coverage in their health plans. Novo’s move follows a similar initiative Lilly has undertaken for Zepbound, which offers the drug at anywhere from $349 to $499 a month depending on the dose level. Novo said its program is an alternative to “fake or illegitimate compounded” versions of Wegovy. — Jonathan Gardner
GenAssist, a Suzhou, China-based biotechnology company, has been cleared to begin testing in the U.S. a first-of-its-kind gene editing treatment for Duchenne muscular dystrophy. Called Gen6050x, the therapy uses a technology known as base editing in an attempt to permanently restore expression of the muscle-protecting protein dystrophin. It’s specifically being developed for Duchenne patients who are “amenable” to exon 50 skipping. GenAssist has already treated two patients in a study in China. — Ben Fidler
Mikael Dolsten, who until Jan. 1 was Pfizer’s top scientist and research and development head, will lead the board of directors of Orbis Medicines, the biotechnology startup said Wednesday. Orbis raised just under $100 million in a Series A round it announced in January, funds that will help it develop a type of oral peptide drug meant to blend the strengths of biologics and small molecules. “I believe Orbis Medicines has the potential to become the leading oral macrocycles and oral biologics biotech company,” said Dolsten. Prior Orbis board chair Morten Graugaard became CEO of the company earlier this year. — Ned Pagliarulo
The Food and Drug Administration has put on hold a Phase 1/2 trial of BioNTech’s RNA-based vaccine for malaria prevention, according to a securities form filed Tuesday. The company said it paused the study while it works to “address the FDA’s requests” and “assess next steps.” Roughly 180 malaria-naive adults were enrolled into the experiment, which was designed to measure the shot’s immunogenicity and safety. The FDA also recently put on hold a Moderna study of an RNA vaccine for norovirus after one case of Guillan-Barré syndrome was reported. — Ned Pagliarulo