eClinical Technology and Industy News

Alnylam Submits CTA Application for ALN-KHK, an Investigational RNAi Therapeutic for the Treatment of Type 2 Diabetes

–Company Expects to Initiate a Phase 1/2 Study for ALN-KHK in Early 2023, with Initial Results Expected in Late 2023 –

Excerpt from the Press Release:

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi (RNA interference) therapeutics company, announced today that the Company has submitted a Clinical Trial Authorization (CTA) application to Health Canada to initiate a Phase 1/2 study of ALN-KHK, an investigational RNAi therapeutic targeting ketohexokinase (KHK) for the treatment of Type 2 diabetes mellitus (T2DM). Pending regulatory authority and ethic committee approvals, the Company plans to begin enrollment in a Phase 1/2 study in healthy overweight to obese volunteers and obese patients with T2DM in early 2023, and expects to report initial human data in late 2023.

“We are excited to advance ALN-KHK to the clinic as our first RNAi therapeutic to address the unmet medical need in Type 2 diabetes mellitus and potentially other metabolic disorders,” said Neil Wallace, Program Leader for the ALN-KHK program at Alnylam. “Increased dietary fructose consumption, largely resulting from use of high-fructose corn syrup as a sweetener, is believed to contribute to the growing pandemic of obesity. Obesity is a significant risk factor for both T2DM and fatty liver disease. Fructose itself predisposes to fatty liver disease and thus, in the context of T2DM, aggravates insulin resistance. We believe targeting ketohexokinase, also known as fructokinase, the first enzyme in the pathway of fructose metabolism, is a novel therapeutic approach to reduce fatty acid synthesis and insulin resistance, with the potential to improve overall glycemic control in individuals with T2DM.”

ALN-KHK is a wholly-owned asset in the Alnylam clinical development portfolio.

ALN-KHK is an investigational, subcutaneously administered RNAi therapeutic targeting ketohexokinase for the treatment of Type 2 diabetes mellitus (T2DM). ALN-KHK utilizes Alnylam’s Enhanced Stabilization Chemistry Plus (ESC+) GalNAc-conjugate technology, which enables subcutaneous dosing with increased selectivity and a wide therapeutic index.

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