Omeros said Monday that its drug OMS824 will get special incentives as regulators review the drug as a treatment for Huntington’s disease. Its shares rose more than 4 percent in morning trading.
The Seattle biotechnology company said the Food and Drug Administration designated OMS824 as an orphan drug when it’s used as a treatment for Huntington’s.
Orphan drug status is awarded to medications that are designed to treat diseases that affect fewer than 200,000 people in the U.S. and represent a major improvement in treatment. The status comes with regulatory incentives, reduced fees, a faster review by the FDA, and it means competing drugs could be blocked from the market for up to seven years.
Huntington’s disease is a rare inherited disease that usually strikes people in their late 30s or early 40s. It begins with uncontrollable twitches, and later causes deterioration of mental abilities until patients can barely eat, speak or walk. Death occurs a decade or more after symptoms begin. The company says about 31,000 people in the U.S. have the condition.
Most Read Business Stories
OMS824 is designed to work by blocking an enzyme that is associated with diseases that affect cognition, including Huntington’s disease and schizophrenia. Omeros says OMS824 could treat the cognitive and psychiatric effects and the movement disorders connected to Huntington’s disease. The company wants to start a mid-stage trial in Huntington’s disease later this year. It is already running a mid-stage trial of OMS824 as a treatment for schizophrenia.
Omeros does not have any approved drugs. The company has asked the FDA and European Union regulators to approve a drug called OMS302. That drug is a combination of two topical medications that are used in lens replacement surgeries for cataracts and other conditions. One component causes pupil dilation and the other is an anti-inflammatory drug intended to reduce pain and irritation after surgery.