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Make way for piglets

February 14, 2024
Reporter, Morning Rounds Writer
Good morning. Piglets. Private equity. Pain. Peruse.

xenotransplantation

Make way for piglets

Yesterday, Japanese startup PorMedTec announced the birth of three cloned CRISPR'd piglets, paving the way for human trials of cross-species organ transplants in that country. Born over the weekend, the piglets were created from cells imported from Boston-based xenotransplant company eGenesis that contain DNA edits to make them less likely to trip the human immune system and to eliminate the risk of transmitting pig viruses to human recipients. The two companies are jointly advancing the development of genetically engineered pig kidneys to treat patients with end-stage renal failure in Japan, STAT's Megan Molteni tells us.
 
Organ shortages are a global issue, but the situation is especially dire in Japan, where transplants from brain-dead donors were banned until the late 90s and traditional beliefs still hinder the practice. Wait times for a kidney average about 15 years and only 2% of people on the waitlist for any organ live long enough to receive one. "Cloning technology will enable the use of an alternative organ supply using genetically engineered porcine donors," PorMedTec's founder and chief scientist Hioshi Nagashima said in a statement. "Our goal is to provide a sustainable supply of organs to all patients in need of a transplant."
 
In addition to enabling clinical trials, Nagashima told STAT in October, the cloning project is also a test of PorMedTec's cryopreservation technologies, which could enable the companies to distribute eGenesis pigs worldwide in the future.

business

Private equity investment in Medicare Advantage plans declines

STAT reporters have been watching two big topics in the business of health: Medicare Advantage plans and private equity investors. Now Brittany Trang tells us about both. Insurance titans UnitedHealthcare and Humana have edged out private equity firms from investing in Medicare Advantage, according to a new report. That doesn't mean private equity investors have left this space: Instead, they're backing companies involved in enrolling seniors in MA plans and keeping track of them once they're there. 

These investors are increasingly investing in insurance brokerages, marketers, in-home assessment companies, and "insurtechs," the report said, based on a new analysis of such deals since 2016 by the Private Equity Stakeholder Project. The decline in private equity interest comes as the Medicare Advantage program is in flux — insurers are starting to see profits dip as seniors get care at higher rates, and the government is making high-profile, if gradual, changes to the way it pays insurance companies who participate. Read more.


drug pricing

Opinion:  The U.S. is still not taking advantage of lower-cost biosimilars for Humira

Biosimilars — versions of branded biologic medications  — are supposed to bring us lower prices, right? So far, that hasn't been the case for nine biosimilars launched in the past year as alternatives to Humira, the world's bestselling drug for rheumatoid arthritis, Crohn's disease, and other autoimmune disorders. Patients aren't seeing those lower costs because policymakers haven't taken the action necessary to ensure these lower-cost products are accessible for patients, Juliana Reed, executive director of the Biosimilars Forum, says in a STAT First Opinion.

Humira, which can cost more than $84,000 a year, is still being placed by pharmacy benefit managers on a preferable formulary tier that insurers use, requiring fewer restrictions for a patient to access it relative to its lower-cost biosimilar alternatives. "It should be a given that formularies should cover lower-cost biosimilars for the benefit of the patients they serve, but this is not happening," she says. Read more on why.



closer look

There's a new competitor in the race to develop new pain medicinesLatigo-1600x900

Illustration: Christine Kao; courtesy Steve Shoffner & Michael Haber

For years, new options for non-opioid pain medicines have been hard to find. But just last month, biotech giant Vertex Pharmaceuticals, known for its treatment for cystic fibrosis and sickle cell disease, reported that its medication VX-548 succeeded in a pair of Phase 3 clinical trials, signaling plans for a new era of drug development, including a focus on painkillers. A new biotech launched today with $135 million and plans to compete with Vertex.

After three years of being incubated by California VC Westlake Village BioPartners, the startup, called Latigo Biotherapeutics, has already completed a Phase 1 trial for a non-opioid pain medicine, LTG-001. It's an oral therapy designed to silence pain-signaling neurons by blocking a sodium channel called NaV 1.8. The company hasn't released its Phase 1 data yet, but "the Vertex data is good news," said interim Latigo CEO and Westlake operating partner Desmond Padhi (above center, with board chair Nancy Stagliano and Westlake founding managing director Sean Harper). STAT's Allison DeAngelis explains.


health

HPV vaccination rates in kids climb with age, but lag other countries

Screenshot 2024-02-13 at 2.44.13 PM

CDC 

The HPV vaccine is a success story in some countries, including the U.K., where it beat estimates of how long it would take to nearly eliminate cervical cancer, the disease it is designed to prevent, among young women. And that was more than two years ago. Last month, a study in Scotland found no cases of cervical cancer in women who were vaccinated before age 14. In the U.S., it's still a work in progress. A CDC report out today tells us that 39% of children age 9 to 17 had received at least one dose of the HPV vaccine, with rates rising with age from 7% in the youngest kids  to 57% in the oldest. Some differences in who got vaccinated:

  • By insurance: Private health insurance (42%), Medicaid (37%), other government coverage (30%), and no insurance (21%).
  • By neighborhood: Large central metropolitan areas (4o%), large fringe metropolitan areas (41%), and medium and small metropolitan areas (39%), and nonmetropolitan areas (30%). 

exercise and infection

Study links Novid to physical activity at 45 and up

There aren't many people who haven't had Covid-19 yet, but a new paper in JAMA Network Open offers a clue to why some older people may have avoided infection and hospitalization for the disease. In a prospective cohort study of more than 61,000 people age 45 and older through May 2022, participants who met recommendations for the metabolic equivalent of 7.5 hours of exercise per week (a measure of energy expenditure) before the pandemic were less likely to develop Covid-19 or need hospital admission to treat it. 

A subgroup analysis found that only women who were sufficiently active had lower odds of infection compared to less active peers, potentially due to differences in respiratory system physiology, the authors suggest, noting that other studies link older age, male sex, ethnicity, low socioeconomic status, and multiple morbidities to a higher risk of Covid-19 and more severe cases. "Future studies including quantitative control of [physical activity] parameters, broader racial and ethnic diversity, and information from other potential confounders (e.g., sleep quality, dietary patterns, access to health care, and preventive behaviors) are warranted," they conclude.


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What we're reading

  • CDC plans to drop five-day Covid isolation guidelines, Washington Post

  • Lawmakers eye partial increase for Medicare doctor pay, STAT

  • FDA advisory panel votes in favor of Abbott's new heart device, STAT
  • Startup BioAge raises $170 million Series D for Zepbound combination therapy, STAT


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