Meeting leads to 'path forward' for next trial.
Lykos Therapeutics’ leadership team met with the Food and Drug Administration last week to discuss advancing midomafetamine capsules as a treatment option for PTSD.
The meeting, attended by interim CEO Michael Mullette and Chief Medical Officer Dr. David Hough, resulted in the outline of a path forward for the potential therapy, the company said in an Oct. 18 news release.
According to the company, the FDA discussions yielded two key developments: plans for an additional Phase 3 trial and the possibility of an independent third-party review of existing Phase 3 clinical data.
Lykos indicated it will continue collaborating with the FDA to finalize the plan and will provide updates as developments warrant. The company did not provide specific timelines for the new trial or data review process.