Clinigen Group plc’s Idis Managed Access (MA) division and Neuraltus Pharmaceuticals, Inc., a privately held biopharmaceutical company focused on the development of drugs to treat neurodegenerative diseases, have announced that the companies are partnering to initiate a Managed Access programme for NP001, Neuraltus’ investigational therapy for amyotrophic lateral sclerosis (ALS).
The partnership makes the Managed Access programme immediately available in selected European countries and is expected to gradually expand during the next year.
ALS, or Lou Gehrig’s disease, is a rare and fatal neurodegenerative disease characterized by the degeneration of motor neurons in the spinal cord and brain. There are approximately 400,000 ALS patients worldwide, including 50,000 patients in Europe. Most patients and physicians report only modest slowing of ALS progression from existing treatments for ALS, underscoring the need for new and effective drug therapy.
“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,” said Simon Estcourt, Managing Director, Idis Managed Access, Clinigen Group. “Our global regulatory and logistical expertise mean that we can deliver a fast and efficient response to physician enquiries. We look forward to working with both Neuraltus and the ALS community, to help patients in Europe who have no other available treatment options.”
“Managed Access programmes are about giving patients timely access to potential new therapies for devastating diseases, before the therapies are approved for general use,” said Rich Casey, President and Chief Executive Officer at Neuraltus Pharmaceuticals, Inc. “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 programme in Europe, underscores our commitment to the ALS community.”
Access to NP001 will be provided by Idis MA to individual ALS patients who meet the established eligibility criteria via a regulatory compliant mechanism, following a physician request. European healthcare professionals can obtain details about the NP001 Managed Access programme by calling +44 (0)1932 824 123 or via email at email@example.com. Additional information can also be found on Neuraltus’ website.