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news.Clinigen's Idis Managed Access division has partnered with Neuraltus Pharmaceuticals to provide access in Europe to a drug the latter is developing for amyotrophic lateral sclerosis (ALS).
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The companies will start a managed access program in selected countries for NP001, Neuraltus’ investigational therapy for ALS. Coverage is planned to be expanded in the next year.
Idis will provide access to the drug for patients who meet eligibility criteria after a request from a physician.
NP001 is an intravenous investigational therapy that reduces neuroinflammation via regulation of macrophage white blood cells within the central nervous system, which are believed to be related with the progression of ALS.
Clinigen said ALS is a rare and fatal neurodegenerative disease characterized by the degeneration of motor neurons in the spinal cord and brain.
There are about 400,000 ALS patients globally, of which 50,000 are in Europe.
Clinigen managing director of Idis Managed Access Simon Estcourt said: "By partnering with companies like Neuraltus, Idis Managed Access plays a vital role in providing ethical access to unapproved medicines, like NP001, for patients with unmet medical needs.
"We look forward to working with both Neuraltus and the ALS community, to help patients in Europe who have no other available treatment options."
Neuraltus Pharmaceuticals president and CEO Rich Casey said: "We have received numerous inquiries from physicians, patients and their families regarding access to and inclusion in clinical studies for NP001.
"The planned Phase 2 study in the United States, coupled with our ability to provide NP001 to qualifying patients under a Managed Access program in Europe, underscores our commitment to the ALS community."