Alzheimer’s disease treatments for genetically at-risk patients
• By Marc Wortman
Martin Tolar, a neurologist and neuroscientist by training and longtime AD R&D leader and dealmaker, believes that tramiprosate, a red-algae derivative that failed Phase III trials in 2007, had, in fact, significant disease-modifying benefit for a specific subset, but still a majority, of patients in the study. He founded Alzheon Inc. around a prodrug of tramiprosate and related intellectual property to pursue what he sees as a high-speed, low-cost pathway to test whether trampirosate could become the first approved AD drug in more than a decade – and the first personalized to a genetically identifiable patient population.
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CEO Paul Stoffels said gaining US clearance for an IND for its novel CAR-T product was demanding, but now opens up a pathway towards a pivotal study starting in 2025.
A final rejection of Leqembi could also spell the same fate for Lilly’s rival drug but public outcry and demand for Alzheimer’s therapies might force the regulator’s hand
Lupin's choice of a Cimzia biosimilar candidate and partnering with Zentiva reflect a strategy to sort the wheat from the chaff. Of 118 biologics to lose patent protection between 2025 and 2034 as per IQVIA, it’s going for a biosimilar with a single competitor though there could be other spoilers