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Msg  35005 of 35016  at  10/25/2021 10:17:26 AM  by

Steve_382


Endpoints on Metacrine NASH program delay.

 
October 25, 2021 07:36 AM EDT R&D Another NASH player retreats from battered field after toxicology study flags potential delay Amber Tong Senior Editor NASH, the notorious liver disease afflicting an increasing number of Americans, has always been the focus at Metacrine ever since serial entrepreneur Rich Heyman unveiled the first round of financing all the way back in 2015. Not anymore. The San Diego-based biotech is halting its NASH program and choosing instead to prioritize its effort in pushing the same FXR agonist, MET642, into a Phase II trial for inflammatory bowel disease. advertisement advertisement Metacrine joins a long line of biotechs taking a step back from NASH. Just this year, NGM and Enanta have shifted focus in the wake of trial flops; and that’s following setbacks at Genfit, Intercept, CymaBay and Albireo. According to Metacrine, preliminary results from a nine-month animal toxicology study have flagged the need for a review — which will determine whether it needs another long-term animal toxicology study before starting Phase III in IBD. Even though Metacrine called an interim readout from a 16-week Phase IIa trial positive, CEO Preston Klassen suggested it’s not worth the “significant capital and resources required” to move into a large late-stage trial at this time. “This decision was influenced in part by a potential delay in confirming appropriate safety margins in our long-term toxicology work that would impact the timing of future NASH studies, but is unlikely to impact timelines for the IBD clinical program,” he said. FXR-based therapies, he added, hold great promise in IBD because of their role in intestinal function. Plus, unlike other therapies for the disease, it doesn’t come with immunosuppression. Still, Metacrine isn’t entirely giving up on NASH. A 3mg dose of MET642 demonstrated “meaningful liver fat reduction” and a decent tolerability profile — although the higher dose presented a murkier picture. The belief now, echoing the strategy being pursued at battle-tested Gilead and Novo Nordisk, is that treating NASH will likely require combination regimes, Klassen noted, of which MET642 can be a part. “In this small interim analysis, the 6 mg cohort displayed a non-normal distribution in liver fat changes, as evidenced by differences between the mean and median results,” he said. “Further clarification of the impact on liver fat at the 6 mg dose will require examination of the complete trial data set, which is anticipated in the first half of 2022.” AUTHOR Amber Tong 


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