May 4, 2023
Barry Bunin, PhD
Founder & CEO
Collaborative Drug Discovery
"Eli Lilly to Seek Approval of Obesity Drug that Could Disrupt Weight Loss Market" That headline from the Financial Times notes the company's intentions to move beyond the market for type-2 diabetes, for which it already has FDA approval, to expand into the weight loss market. An Eli Lilly study found that over a 17-month period, subjects lost almost 16 percent of their body weight. "A new class of obesity and diabetes drugs that in some cases can produce weight loss equivalent to bariatric surgery, is driving patient demand and investor excitement in the sector. Demand for the treatments has been fuelled by endorsements on social media by Hollywood stars and celebrities," the article reports.
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Easing Up on the Accelerator of FDA Accelerated Approvals. Derek Lowe recently wrote about the FDA looking at tightening the process for allowing accelerated approvals. "The FDA is letting the industry know that it's interested in streamlining the accelerated approval process for new cancer drugs, but that they're not interested in making it too easy, either. They're open to the idea of a "one-trial" route to such approvals, but it had better be a good trial," Lowe writes in his Science blog. He points to an article in The Lancet about the PI3K inhibitors for leukemia and other malignancies, and notes: "Several of these compounds were given accelerated approvals, but they've proven to be more toxic than the first trials indicated. The drugs still work; it's just that their risk/reward isn't as favorable as hoped." He ends by saying: "People who see the agency as a roadblock in the way of zippy progress aren't always wrong about that, but some of the 'progress' you can show by flooring the accelerator is an illusion, too. . ."
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"Sniffing Out Cancer with Animal Noses." That's the intriguing headline of a recent article in Drug Discovery News reporting "Dogs, locusts, ants, and even worms detect human cancers at earlier stages than current tests, leading the way to better cancer diagnostics." Researchers were intrigued by multiple reports of pet dogs insistently sniffing moles on the legs of owners-in one case trying to bite it off. When owners had the moles examined, they were malignant. How is this possible? The article explains: "While undetectable to the human nose, all cells release volatile organic compounds (VOCs) as they perform their day-to-day cellular activities. When cells become cancerous, their metabolisms change, so the compositions of VOCs they emit change as well. With their more sensitive noses, animals have no problem smelling these changing combinations of VOCs." Researchers went on to find the same was true of a number of insects. Researchers hope to use animals-and insects-to help them identify the VOCs and other chemical changes that signify cancer and create an AI-powered device for detection. The article quotes Claire Guest, the founder of Medical Detection Dogs: "For cancer detection, it's never been about thousands of dogs sniffing in doctor's waiting rooms. It's always been about how we can convert what we know to a device that can mimic nature."
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"Biotech Startups Use Models of Human Organs for Drug Discovery." The Wall Street Journal carries this headline on an article about how miniature models of human organs may provide a more accurate predictor of drug efficacy than animal testing. The research got a nudge forward when a federal law passed in December-the FDA Modernization Act 2.0-permitted drugs to enter clinical trials without first being tested in animals. The law lays out acceptable nonanimal techniques such as computer modeling and cell-based tests to vet drugs before human trials. Th goal is to coax cells to aggregate into structures akin to a functioning organ. Arnold Kriegstein, a professor of neurology at UCSF Weill Institute for Neurosciences, sees the organoids as useful for, among other uses, exploring signaling pathways in the developing brain. He said, "This allows us to have a window into brain function that we really can't have any other way."
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Barry A. Bunin, PhD, is the Founder & CEO of Collaborative Drug Discovery, which provides a modern approach to drug discovery research informatics trusted globally by thousands of leading researchers. The CDD Vault is a hosted biological and chemical database that securely manages your private and external data.