Omeros has received fast-track designation from the US Food and Drug Administration (FDA) for its phosphodiesterase 10 (PDE10) inhibitor ‘OMS824’ to treat cognitive impairment in patients with Huntington’s disease.
OMS824 selectively inhibits PDE10, an enzyme that is expressed in areas of the brain linked to diseases that affect cognition and psychomotor functions, including Huntington’s disease and schizophrenia.
Go deeper with GlobalData
Omeros has carried out successful clinical trials evaluating the safety, tolerability, pharmacokinetics and target engagement of a wide range of doses of OMS824 in its Phase I programme.
The company recently released positive data of its OMS824 Phase IIa schizophrenia trial and also expects to start enrolling patients this quarter in its Phase II trial evaluating OMS824 for Huntington’s disease.
The FDA fast-track programme helps in the development of drugs intended to treat serious or life-threatening conditions and that have the potential to address unmet medical needs.
Omeros chairman and chief executive officer Gregory Demopulos said: “Together with the orphan drug status previously awarded OMS824 by the FDA for Huntington’s, we have the opportunity to streamline the development of this promising compound.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“We look forward to enrolling patients in our OMS824 Phase II clinical trial for Huntington’s disease within the next few weeks.”
Huntington’s disease (HD) is a hereditary neurodegenerative genetic disorder that affects muscle coordination and leads to cognitive decline, psychiatric problems, behavioural abnormalities and premature death.
According to Omeros, OMS824 helps improve the motor and psychiatric abnormalities in Huntington’s disease, as well as the positive (hallucinations) and negative (flat affect) symptoms of schizophrenia.
Omeros has also obtained Orphan Drug Designation from the US FDA to evaluate OMS824 in Huntington’s disease, with fast-track application to the FDA for the evaluation of OMS824 in schizophrenia currently under review.
Image: A montage of three images of single striatal neurons transfected with a disease-associated version of huntington, the protein that causes Huntington’s disease. Photo: courtesy of Leevanjackson.
