Drugmaker AstraZeneca said on Tuesday that it had received positive high-level results from a planned interim analysis of its NEURO-TTRansform Phase III trial on its eplontersen candidate.
AstraZeneca stated the 35-week analysis revealed eplontersen had met co-primary and secondary endpoints in the hereditary transthyretin-mediated amyloid polyneuropathy study, reaching a “statistically significant and clinically meaningful” improvement from baseline in the percent change in serum transthyretin concentration, reducing TTR protein production. AZN also said the trial had met its co-primary endpoint of change from baseline in the modified neuropathy impairment score +7 – a measure of neuropathic disease progression.
The FTSE 100-listed firm added that the high-level results showed the trial had reached its secondary endpoint of change from baseline in the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy, showing treatment with eplontersen “significantly” improved patient-reported quality of life versus the external placebo group.
Based on the 35-week interim trial results, AZN and its partner Ionis will seek regulatory approval for eplontersen and plan to file a new drug application with the US Food and Drug Administration in 2022.
As of 0845 BST, AstraZeneca shares were up 0.14% at 10,068.0p.
Reporting by Iain Gilbert at Sharecast.com
