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Prime Medicine Announces The New England Journal of Medicine Publication of PM359 Clinical Data for the Treatment of Chronic Granulomatous Disease
CAMBRIDGE, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotec...
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[{"type":"text","content":"Prime Medicine Announces The New England Journal of Medicine Publication of PM359 Clinical Data for the Treatment of Chronic Granulomatous Disease\n\n\n\n CAMBRIDGE, Mass., Dec. 07, 2025 (GLOBE NEWSWIRE) -- Prime Medicine, Inc. (Nasdaq: PRME), a biotechnology company committed to delivering a new class of differentiated one-time curative genetic therapies, today announced the publication of Phase 1/2 clinical data with PM359, the Company’s investigational autologous hematopoietic stem cell product for p47\n \n phox\n \n chronic granulomatous disease (CGD) in the\n \n New England Journal of Medicine (NEJM).\n \n The data will also be presented in a poster session at the 67\n \n th\n \n American Society of Hematology (ASH) Annual Meeting, December 6-9, 2025 in Orlando, Florida.\n \n\n The publication, titled “Prime Editing for p47-phox Chronic Granulomatous Disease,” reports initial data for two patients treated in the Phase 1/2 trial of PM359, which was designed to assess safety, biological activity and preliminary efficacy in adult and pediatric study participants. Both patients experienced rapid neutrophil and platelet engraftment, as well as durable restoration of NADPH oxidase activity and early clinical benefit, without any safety concerns. Together, these results provide the first-in-human demonstration of the safety and efficacy of Prime Editing, and support the potential for PM359 as a precise therapeutic strategy for CGD:\n \n\n\n Both patients enrolled in the study had a history of prior CGD-defining complications, including CGD-associated colitis (CAC), and skin and soft tissue infections, and both were maintained on long-term prophylactic therapy.\n \n\n Both patients experienced rapid neutrophil engraftment, achieving 69% and 83% dihydrorhodamine-positive (DHR+) neutrophils by Day 30, respectively, far in excess of the 20% projected minimum threshold for clinical benefit. DHR activity remained stable over time in both patients, suggesting that gene correction occurred in the long-term repopulating hematopoietic stem cells (HSCs) of the bone marrow.\n \n\n Both patients remain free of new CGD-related complications or significant intercurrent illnesses post-infusion; additionally, Patient 1 stopped his mesalamine treatment and has not experienced a flare of CAC, and Patient 2’s levels o...