- Clinical Trials
- Research News
- Industry Trends
- Agency Actions
- Drug Safety Issues
- Approvals, Launches, & New Indications
- Health Care Reform
FDA Grants Fast Track Designation to Huntington's Disease Treatment
PDE10 inhibitor enters phase II study (February 5)
The FDA has granted a “fast track” designation to OMS824 (Omeros Corporation), a phosphodiesterase 10 (PDE10) inhibitor, for the treatment of cognitive impairment in patients with Huntington’s disease (HD).
The agency’s “fast track” program facilitates the development of drugs that are intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs.
OMS824 selectively inhibits PDE10, an enzyme expressed in areas of the brain linked to diseases that affect cognition, including HD and schizophrenia. Enrollment into a phase II trial of OMS824 in patients with HD is expected to begin this quarter.
HD is a hereditary neurodegenerative disorder that leads to movement, cognition, and behavioral abnormalities and premature death. Cognitive dysfunction is responsible for substantial disability in HD and is not meaningfully improved by current medications.
In addition to its potential beneficial effects on cognition, OMS824 may also improve the motor and psychiatric abnormalities in HD.
Source: Omeros Corporation; February 5, 2014.