Wegovy, Merck, Gameto, and Neurocrine

May 29, 2024

69 4 minutes read

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Good morning. I hope everyone had a restful Memorial Day weekend. I myself was engaged in what my editor calls one of the greatest joys in life — packing up all my belongings, moving two miles, and then unpacking all of my belongings.

Let’s get into the news of the day.

The need-to-know this morning

FDA’s new guidance could streamline gene therapy approvals

From STAT’s Jason Mast: The FDA released draft guidance yesterday on a new “platform designation” companies can apply for, part of a broader effort to update the agency’s approach to medicines made with new, genetic technologies.

The guidance is useful in areas where multiple therapies can be made with a single backbone technology. For example, companies might treat different genetic disorders by delivering different genes in the same engineered virus. A platform designation would make it easier for a company to take data it used to get a first gene therapy approved — such as manufacturing analysis, inspections, or certain animal safety studies — and re-use that data again to get the next drug approved, rather than re-doing everything from scratch.

In addition to viral gene therapy, the FDA notes it could apply the designation to platforms that use antibodies, siRNA (such as Alnylam’s drugs), and lipid nanoparticles, the bubbles of fat used to deliver mRNA for Covid vaccines and now being applied in gene editing and other rare disease drugs. The new designation is one of several programs FDA biologics chiefs Peter Marks has proposed to speed the development of new drugs, particularly for very rare diseases.

Wegovy linked to lower risk of alcohol use disorder in real-world study

A new observational study in Nature Communications found that Wegovy was linked to a 50% and 56% lower risk of incidence and recurrence of alcohol use disorder over one year compared with other obesity medications. The sister diabetes drug Ozempic was linked to a 44% and 39% lower risk of incidence and recurrence versus other diabetes treatments.

The researchers behind this study, which include Nora Volkow (director of the National Institute on Drug Abuse), previously found similar trends when looking at cannabis use disorder.

There have been anecdotes that GLP-1 drugs like Ozempic and Wegovy not only reduce cravings for food, but also for substances like alcohol and tobacco. But no pharma company is so far running a randomized trial to specifically test GLP-1s in addiction. The closest type of study is a trial by Novo Nordisk in alcohol-related liver disease that will test alcohol intake as a secondary outcome.

Speaking at a STAT event earlier this year, Volkow said the early data on GLP-1s in addiction is “very, very, exciting,” and she lamented drug companies’ lack of research in this space.

The GLP-1 revolution is leaving Black Americans behind

KIERRA BRANKER FOR STAT

Though GLP-1 drugs like Ozempic and Wegovy are transforming the treatment of diabetes and obesity (and potentially many other conditions as shown above), many Black Americans worry that their community, which already experiences a greater burden of chronic disease, is being left behind.

Recent studies found that Black people with diabetes are less likely to be prescribed GLP-1 drugs. They also experience significant insurance and access barriers, and the public’s obsession with the drugs further serves as a reminder of how Black bodies are policed and judged by society.

STAT teamed up with Word In Black, a network of 10 Black news publishers, to report this story. Read more from Word In Black’s Anissa Durham here, and also take some time to look at the accompanying article that includes a photo essay and first-person accounts of how Black Americans are thinking about their weight and the pressure to lose weight in this new Ozempic era.

Investors pour money into fertility-focused biotech

Gameto, a biotech aiming to improve on IVF, said today that it raised $33 million in a Series B round led by Two Sigma Ventures and RA Capital.

In IVF, eggs are taken out of a woman’s body and fertilized, but often times, the eggs that are taken out are not mature enough and have to be tossed. The idea behind Gameto’s lead product, Fertilo, is in-vitro maturation (IVM) that may improve the odds of success in IVF. Fertilo is a solution that contains “ovarian support cells” that are meant to help nudge the eggs that are removed from the body into maturing.

Fertilo is already in clinical use in Australia and Latin America, and in the U.S., Gameto has tentative approval to start Phase 3 trials upon completion of certain assay and manufacturing requirements.

For more background on this startup, check out our story from last year.

Neurocrine names new CEO as it looks to new growth phase

Neurocrine said yesterday that its founding CEO, Kevin Gorman, will retire, and Kyle Gano, currently the chief business development and strategy officer, will succeed him.

Stifel analyst Paul Matteis wrote that this feels like “somewhat of a natural transition point for the company,” as its approved tardive dyskinesia drug Ingrezza is well-established, and as it turns to a new phase of growth with the anticipated launch of a congenital adrenal hyperplasia drug and with several drugs in the pipeline.