Neuraly points to younger patients for hope as Parkinson's bet fails phase 2

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来源: FierceBiotech

A post hoc analysis revealed a potential treatment effect in patients 60 years or younger, which accounted for 37% of the study population.

A Parkinson’s disease treatment from Neuraly, a biotech spun out from the Johns Hopkins School of Medicine, did not improve motor experiences of daily living or movement in a mid-stage trial, but the investigators did flag a better result for younger patients.

The glucagon-like peptide-1 receptor drug NLY01 was being tested in a phase 2 placebo-controlled study of 255 patients with early, untreated Parkinson’s disease. The study was looking for changes on a common Parkinson’s scale that assess disease burden, following patients for 36 weeks of treatment and again eight weeks after discontinuation.

In top-line results reported Monday, Neuraly said NLY01 was unsuccessful on the primary endpoint but the therapy was safe and well tolerated.

But a post hoc analysis revealed a potential treatment effect in patients 60 years or younger, which accounted for 37% of the study population. Neuraly said these patients saw a five-point reduction on the Parkinson’s scale, which was clinically significant, compared to placebo. The effect was statistically significant, dose-related and continued for eight weeks after treatment with NLY01 was discontinued, the company said.

Neuraly will present more detailed data at future medical meetings. CEO Seulki Lee was noncommittal on NLY01’s future, saying that the biotech would analyze the data “to better understand the outcomes and determine the next steps for NLY01,” according to the press release.

Neuraly is a subsidiary of D&D Pharmatech, a technology and financial holding company that forms units to go after specific disease areas. The neurology startup Neuraly was formed in 2016 based on research from the Johns Hopkins School of Medicine. NLY01 is the unit’s lead asset and is in phase 2 testing for Alzheimer’s disease as well.

Other assets include NLY02 for Parkinson’s and Alzheimer’s and NLY03 for stroke and Parkinson’s, both of which are in preclinical development.

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