For investors, weight loss still trumps tolerability

From STAT's Elaine Chen: An obesity drug developed by Zealand Pharma and Roche resulted in up to 10.7% weight loss over 42 weeks in a Phase 2 trial, delivering lower efficacy than what's been observed with competitor treatments.

But the drug, which targets the amylin hormone, appeared much more tolerable than other therapies, which can lead to a range of gastrointestinal side effects. Among all patients treated with the drug, called petrelintide, just 1.5% discontinued due to GI adverse events. Zealand also said the rate of vomiting among treated patients was lower than the rate in the placebo group, and the rates of diarrhea and constipation were consistent with those seen with placebo and remained in the single-digit range.

Despite the tolerability, investors were disappointed by the efficacy and sent American depository receipts of Roche down over 6% yesterday.

Scientists have hypothesized the amylin mechanism may be more tolerable than the GLP-1 mechanism used by many drugs like Wegovy and Zepbound. But there have been questions about the efficacy of the mechanism. Novo Nordisk's CagriSema, an amylin and GLP-1 combination therapy, has led to less weight loss than initially hoped.

Zealand CEO Adam Steensberg said the industry has been too focused on the magnitude and speed of weight loss, and having a tolerable drug will help patients stay on treatment for a longer time.

"Petrelintide is not about chasing headlines for who can achieve the greatest weight loss number," he said on an analyst call yesterday. "It is about redefining the weight management experience."

Zealand executives said they believe the drug can ultimately lead to mid-teens percent weight loss in the Phase 3 program.

vaccines

Moderna's reset hinges on oncology

After a turbulent start to the year — including an unexpected FDA refusal to review its mRNA flu vaccine and a patent settlement that could ultimately reach $2.25 billion — Moderna is trying to steady itself by pivoting away from the Covid-era vaccine business that made it famous.

The company will pay $950 million upfront to settle patent claims tied to its Covid vaccine, but investors reacted with relief and the stock surged upwards. At the same time, the FDA has now agreed to review Moderna's flu shot after initially rejecting the application, offering a modest regulatory reprieve.

Still, the company's long-term strategy increasingly centers on mRNA cancer vaccines — especially a melanoma vaccine being developed with Merck that could deliver pivotal Phase 3 results later this year.

"You can very quickly turn Moderna from a vaccine company into [one where] their primary revenue driver is going to be oncology," health analyst Myles Minter told The Boston Globe.

cancer

FDA fast-tracks Janssen myeloma combo with voucher

In its third approval under the new National Priority Voucher pilot, the FDA approved Janssen's combination of teclistamab and daratumumab for adults with relapsed or refractory multiple myeloma. The decision came just 55 days after filing.

Regulators noted the company's Phase 3 data showing the drug pairing dramatically outperformed standard treatment — cutting the risk of disease progression or death by 83% and reducing mortality by more than half patients who had been treated with another drug beforehand. The same study also converts the bispecific teclistamab, or Tecvayli, from accelerated to full approval.

glp-1 drugs

How the 'holy grail' weight loss pill became a reality (and what comes next)

The era of GLP-1 weight loss pills has officially begun. Novo Nordisk released a new, oral version of its GLP-1 weight-loss drug Wegovy earlier this year. Rival Eli Lilly's GLP-1 pill orforglipron is expected to be approved as early as this month.

A safe, effective weight loss pill was long a holy grail for the pharmaceutical industry. Injectable GLP-1 drugs have been blockbusters since they were approved to treat obesity a few years ago, but until now, an oral form of the medication has been elusive.

In this week's "STATus Report," host Alex Hogan explains why pills were so much harder to develop than injectables and why Novo and Lilly spent so much time and money developing them. STAT reporter, and Readout LOUD co-host, Elaine Chen joins the conversation to discuss whether or not pills will alleviate some pricing and accessibility issues.

Watch here.

podcast

Breaching the IBD efficacy ceiling, and sham surgeries

Will drugmakers finally be able to breach the efficacy ceiling in inflammatory bowel disease? And is the Food and Drug Administration being flexible enough with rare disease treatments?

We discuss all that on this week's episode of "The Readout LOUD."

Spyre Therapeutics CEO Cameron Turtle joins the podcast to discuss his company's experimental IBD medications, and whether the drug industry is scraping the barrel in the search for better treatments. We also discuss the latest news in the life sciences, including the ongoing debate between the FDA and UniQure over its Huntington's disease therapy, as well as Moderna's mammoth patent settlement.

Listen here.

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