> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Regeneron Sees ‘Encouraging’ Garetosmab Results in FOP
- URL: https://www.fdaweb.com/regeneron-sees-encouraging-garetosmab-results-in-fop/
- Published: 2020-01-09T12:00:00.000Z
- Updated: 2026-09-14T15:57:59.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145806

Regeneron says results from the LUMINA-1 Phase 2 trial of its garetosmab in 44 patients with fibrodysplasia ossificans progressiva (FOP) showed about a 25% decrease in total bone lesions (new and existing) driven by a nearly 90% reduction in the formation of new lesions. A company [statement](https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-encouraging-garetosmab-phase-2-results?ref=fdaweb.com) says Regeneron scientists discovered the role of Activin A in FOP, a critical protein in the development of heterotopic ossification, and used Regeneron’s Veloclmmune technology to invent garetosmab, a monoclonal antibody that reduces the formation of heterotopic bone lesions by neutralizing the Activin A protein.

The company says that detailed trial results will be used as the basis of regulatory submissions and that plans are underway for a pediatric trial.