Shared from parkinsonsnewstoday.com.
Risvodetinib, an experimental oral small molecule Abli Therapeutics is developing for people with untreated Parkinson’s disease, may be one step closer to Phase 3 clinical testing, following a meeting with U.S. regulators.
The end-of-Phase 2 meeting’s main goal with the U.S. Food and Drug Administration (FDA) was to define the outcome measures for a Phase 3 study and to see if any more information is needed to file a new drug application, according to a company press release.
The company, which spun off from Inhibikase Therapeutics to focus on treatments for neurodegenerative diseases that arise from the activation of Abelson tyrosine (c-Abl) kinases, has reviewed the design of its planned Phase 3 program that’s building on outcomes of the 201 Phase 2 study (NCT05424276).