Neuraltus and Clinigen Group Launch NP001 Managed Access Program in Europe for ALS

Neuraltus Pharmaceuticals, Inc. recently announced it has partnered with the Clinigen Group plc’s Idis Managed Access (MA) division to launch a program for the former’s product candidate for amyotrophic lateral sclerosis (ALS), NP001. This agreement effectively makes the program available in several European territories, with an estimated growth to more countries as 2016 progresses.

Scientists have long since identified neuroinflammation as a driving factor behind ALS’ pathology. Neuraltus’ NP001 is formulated as a macrophage regulator, working by reverting activated inflammatory macrophages back to their non-destructive state. “Managed Access programs 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 program in Europe, underscores our commitment to the ALS community.”

According to the companies’ agreement on Managed Access, the NP001 will be provided by Idis MA to eligible ALS patients, who will be assessed according to certain criteria, subject to a regulatory compliant mechanism after a physician’s request. Healthcare providers in participating European territories can learn more about the NP001 Managed Access program through +44 (0)1932 824 123 or via email at [email protected]. Detailed product and program information is also available on the Neuraltus’ website.

“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 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.”

Johns Hopkins University researchers have announced that they will present the latest results of a study that reveals increased levels of endothelin 1 (ET-1) in astrocytes in the brain, along with increased levels of ET-B binding protein (the protein that binds to the ET-1 receptor) are associated with amyotrophic lateral sclerosis (ALS) or Lou Gehrig’s disease. The results will be presented at the 14th International Conference on Endothelin: Physiology, Pathophysiology and Therapeutics.