Otsuka tops Vera Therapeutics in kidney disease study showdown

From STAT's Adam Feuerstein: Another example of why biotech is a tough business.

A monthly treatment from Otsuka reduced by more than half the levels of a toxic protein in the urine of patients with an autoimmune kidney disease. The results presented this morning achieved the interim goal of a Phase 3 study and were numerically superior to study results posted Monday by a competitor, Vera Therapeutics.

The Otsuka drug, called sibeprenlimab, lowered proteinuria levels by 50.2% after nine months compared to an increase of 2.1% in patients given a placebo. The statistically significant difference was 51.2%.

Both Otsuka and Vera are racing to develop their respective drugs as a new treatment for IgA nephropathy, or IgAN, a chronic kidney disease caused by the build-up of antibodies in the kidneys. The condition leads to progressive loss of kidney function and potentially organ failure requiring dialysis.

pharma

GLP-1s linked to low but higher risk of eye disease, study found

A new observational study found that people with diabetes who were taking GLP-1 drugs had a low but elevated risk of an age-related eye disease that can sometimes lead to blindness.

The research, published yesterday in JAMA Ophthalmology, found that after one year, more than twice as many people on GLP-1 drugs developed neovascular age-related macular degeneration compared to similar people who were not taking the drugs. The risk was 0.2% in people taking GLP-1s and 0.1% in those who didn’t.

As usage of GLP-1s has taken off, more eye problems have been reported. It’s not unusual for rare side effects to show up when more people take a drug. (An earlier observational study found that people taking GLP-1s also had a higher risk of nonarteritic anterior ischemic optic neuropathy, when the optic nerve’s blood flow is blocked.)

If there’s a common cause, researchers speculate that it might be plunging blood glucose levels spurred by GLP-1s that trigger abnormal blood vessel growth in the retina.

science

Taurine is not the anti-aging silver bullet, new data suggest

It turns out that taurine, an amino acid that biohackers and longevity seekers have embraced, may not be the promising anti-aging supplement they think it is.

Previous research found that taurine levels declined profoundly over the lives of humans, mice, and monkeys. It also found that taurine supplements extend mice lives by about 10%, while improving muscle function and metabolic markers.

But a new study released yesterday actually found that taurine rises with age when researchers examined cohorts of monkeys, mice and humans, casting doubt on the earlier research.

As my colleague Jason Mast writes, the data are a reminder of just how messy and complicated longevity studies can be, and how elusive treatments, or even just reliable markers, for aging remain.

podcast

Why did the FDA roll out an internal AI tool called Elsa?

We discuss that and more in this week's episode of the “The Readout LOUD.”

STAT's AI reporter, Brittany Trang, joins us to talk about her scoop on the FDA's implementation of the Elsa tool, which, unlike its namesake Disney character, can’t seem to let go of mistakes.

We also discuss Sanofi’s $9 billion offer for Blueprint Medicines and how Novo Nordisk went from leading the obesity market to now trailing competitor Eli Lilly.

Listen here.

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