Clinical-stage biopharmaceutical company Omeros has reported positive data from the multiple-ascending-dose (MAD) portion of its OMS824 Phase I trial to treat cognition-imparing diseases such as Huntington’s and schizophrenia.
According to the data, the lead compound in Omeros’ phosphodiesterase 10 (PDE10) programme, OMS824, has greater brain activity without movement side-effects seen with other PDE10 inhibitors.
OMS824, which selectively inhibits the enzyme PDE10 expressed in areas of the brain correlated to a range of diseases that affect cognition, was well-tolerated in the study.
Omeros chairman and chief executive officer Dr Gregory Demopulos said OMS824 is able to achieve significantly higher concentrations at the target enzyme in the brain, without incurring the movement abnormalities, than other PDE10 inhibitors being developed across the industry.
"While wrapping up the Phase I programme, we are aggressively advancing OMS824 into Phase II trials," Demopulos said.
"Our initial focus will be Huntington’s disease, for which we will be requesting orphan drug as well as fast track designations from the FDA, and a Phase IIa trial in patients with schizophrenia is expected to follow shortly thereafter.
"In addition to our progress in the OMS824 programme, we plan to submit the NDA next quarter and the MAA mid-year for OMS302, our ophthalmic drug product, and we remain on track to advance our MASP-2 and PDE7 programs into the clinic in the coming months."
The randomised, double-blind, placebo-controlled, single and multiple-dose escalation study enrolled 64 healthy male subjects, 40 of which received a single dose and 24 received daily dosing for seven to 10 days.
A linear increase in pharmacokinetic parameters with dose was observed, along with long half-life.
At well-tolerated doses, OMS824 achieved concentrations expected to inhibit PDE10 and support continuing development for the treatment of central nervous system disorders.