A drug that was ‘engineered with AI’ enters Phase 3 testing

Generate:Biomedicines, an AI-focused drug developer, said yesterday that it will start late-stage trials of its investigational drug for severe asthma. The company said this is a milestone since this is one of the first molecules, if not the first, designed with AI to enter Phase 3 testing.

This is a notable development, especially since Generate skipped Phase 2 testing to go straight into Phase 3. But my colleague Brittany Trang reminds me that an “AI-designed drug” is not a hard-and-fast designation and there’s a broad spectrum of AI usage that could fall under that term.

Generate’s drug, she noted, was not created from scratch with AI. Brittany reported earlier this year that the asthma molecule looks to be a tweaked version of an existing, FDA-approved medication.

STAT+ | Top contributors to leading psychiatry journals fail to disclose industry payments, analysis finds

The authors of a new analysis argue undisclosed conflicts are “particularly concerning” because they may “undermine the validity of psychiatric research.”

from Endpoint News:

Aledade said Monday that it secured a $500 million senior secured credit facility. The startup works with primary care practices and clinics to get paid based on how well they take care of patients, and the credit will be used to “bridge the natural timing gap in Medicare payments and the capacity to expand as we continue to scale our business,” CEO Farzad Mostashari said in a news release.

from Politico:

DRIVING THE DAY

A stack of Ozempic boxes.

States are choosing not to cover the new weight-loss drugs, sacrificing a chance to stem cancer, diabetes and heart disease. | David J. Phillip/AP

COVERAGE CONUNDRUM — For state Medicaid programs, choosing whether or not to cover weight-loss medications is not a simple decision.

Medicaid officials across the country are being presented with what looks like a sure bet: Spend big now to cover the costly drugs, called GLP-1s, and reap savings when diabetes, heart disease and cancer rates drop. But states that have added coverage to help the nearly 40 percent of patients who are obese in the state-federal program for low-income people are finding they’re blowing holes in their budgets.

That’s scaring others off from taking the leap, Kelly reports.

“It keeps us up at night,” said Jody Terranova, the medical director of Connecticut’s Medicaid program, which pared back coverage of the drugs after they added more than $100 million to state spending last year. “We talk about it every day.”

Why it matters: The struggle comes as many states are course correcting after finding themselves in deficits — some in the billion-dollar-plus range — and as they brace for nearly $100 billion in annual cuts to Medicaid that President Donald Trump signed into law in July. Even though the effectiveness of the drugs suggests they’ll produce savings as diseases linked to obesity decline, state budgeting isn’t set up to take advantage of such bets when the ante is so steep.

Medicaid’s setup — where the federal government and states share costs, but individual states have discretion over whether to cover anti-obesity treatments — is greatly limiting who can access the life-changing, and sometimes life-saving, medications.

Background: The White House is touting a deal it reached last month with the makers of some of the most popular weight-loss treatments, reducing the price to state Medicaid programs to $245 a month. But how much that’ll save states and whether they take the offer is far from certain.

In Michigan, where Medicaid covers the obesity medications, the new price “doesn’t look too different” than what the state currently pays with a rebate, said Medicaid Director Meghan Groen. Next year, Michigan is restricting coverage to Medicaid patients with severe obesity to reduce spending by $240 million.

For states contemplating adding coverage, savings might not outweigh other considerations, including how many people would qualify for the drugs, how states see their cost-effectiveness and states’ unique budget circumstances.

Meanwhile: Sixteen state Medicaid programs cover GLP-1s to treat obesity. Three of those — California, New Hampshire and South Carolina — are ending coverage next year amid cost concerns. Doctors, who describe the medications as miracle drugs, worry a major opportunity to improve public health could be lost.

“These medications decrease appetite, increase fullness, but it’s almost like they intangibly increase willpower,” said Christopher Weber, an obesity medicine specialist in Wisconsin, where Medicaid covers GLP-1s for obesity, with strict limits. “It’s not sold as that, but I see it every day.”

Read Kelly’s deep dive into Medicaid coverage of anti-obesity medications. 

 

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