Merck Serono acquired worldwide exclusive rights to a Phase II-ready multiple sclerosis candidate, PI-2301, originally developed by Peptimmune, the Cambridge, MA-based peptide therapeutics firm that reportedly filed for Chapter 7 bankruptcy earlier this year after it failed to complete a $35 million fundraising round.
PI-2301 is a second-generation peptide copolymer derived from a similar compound class as Teva Pharmaceuticals’ Copaxone®. PI-2301 is believed to work by enhancing the regulatory response of the immune system, and dampening immune responses that drive autoimmune diseases such as multiple sclerosis. Merck will evaluate the product for autoimmune diseases including multiple sclerosis.
Merck Serono’s marketed MS drug, Rebif® (interferon beta-1a) is a disease-modifying therapeutic used to treat relapsing forms of multiple sclerosis. The drug was approved in Europe in 1998 and in the U.S. in 2002, and is now registered in more than 90 countries worldwide. Studies are in progress to evaluate Rebif in related indications such as clinically isolated syndrome (CIS), which manifests as intermittent neurological attacks that resemble those of multiple sclerosis. An extended release formulation of interferon beta-1a is separately undergoing Phase I clinical development.
The firm’s Phase I stage pipeline includes two additional MS candidates: ARX 424 is a long-acting interferon, and ATX-MS-1467 is an immune-tolerizing agent. Merck Serono is also collaborating with Bionomics on the development of MS therapeutics that target the potassium ion channel Kv1.3, a key modulator of the immune system and a target found on human immune cells associated with nerve cell damage in patients with multiple sclerosis.