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Alnylam Submits CTA Application In UK To Start Phase 1 Trial Of ALN-HSD To Treat NASH

Alnylam Pharmaceuticals Inc. (ALNY) announced Monday that it has submitted a clinical trial authorization or CTA application in the United Kingdom for ALN-HSD, an investigational RNAi Therapeutic targeting HSD17B13 to treat Nonalcoholic Steatohepatitis or NASH.

The application has been submitted to The Medicines and Healthcare Products Regulatory Agency or MHRA in the United Kingdom to initiate a Phase 1 study of ALN-HSD.

The company plans to initiate a Phase 1 study in late 2020, upon obtaining MHRA approval.

ALN-HSD is an investigational, subcutaneously administered RNAi therapeutic targeting HSD17B13 in development in collaboration with Regeneron Pharmaceuticals for the treatment of nonalcoholic steatohepatitis, a highly prevalent chronic liver disease.

The safety and efficacy of ALN-HSD have not been evaluated by the FDA, EMA or any other health authority.

David Erbe, Senior Distinguished Investigator, Program Leader, ALN-HSD program at Alnylam, said, "Given the genetic validation of the target, we believe ALN-HSD has the potential to change the course of this serious and potentially life-threatening disease for which there are currently no approved pharmacologic treatment options."

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