Clinigen to partner on new drug trial
STAFFORDSHIRE pharmaceutical group Clinigen is to undertake trials of a new drug aimed at combating a serious neurological disease.
The Burton-upon-Trent group’s Idis Managed Access (MA) division, together with Neuraltus Pharmaceuticals, a privately-held biopharmaceutical company focused on the development of drugs to treat neurodegenerative diseases, are partnering on a managed access program for NP001, Neuraltus’ investigational therapy for amyotrophic lateral sclerosis (ALS).
The partnership makes the Managed Access program immediately available in selected European countries and is expected to gradually expand over the next year.
ALS, sometimes called Lou Gehrig’s disease, is a rapidly progressive, invariably fatal neurological disease that attacks the nerve cells (neurons) responsible for controlling voluntary muscles (muscle action we are able to control, such as those in the arms, legs, and face).
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.
Simon Estcourt, managing director, Idis Managed Access, 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.
“Our global regulatory and logistical expertise mean that we can deliver a fast and efficient response to physician inquiries. We look forward to working with both Neuraltus and the ALS community, to help patients in Europe who have no other available treatment options.”
Rich Casey, president and CEO at Neuraltus Pharmaceuticals, said MA programs were about giving patients timely access to potential new therapies for devastating diseases, before the therapies are approved for general use.
“We have received numerous inquiries from physicians, patients and their families regarding access to and inclusion in clinical studies for NP001,” he said. “The planned Phase 2 study in the United States, coupled with our ability to provide NP001 to qualifying patients under a MA program 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.
