Promising clinical progress by MS immunotherapy study

Pharma IQ News

Studies conducted by a clinical stage biotech company have seen promising results for a potential therapy for multiple sclerosis.

Apitope’s antigen-specific immunotherapy ATX-MS-1467 looks to support patients with relapsing autoimmune disease - multiple sclerosis. Clinical studies were conducted to assess the safety, tolerability and efficacy of the treatment.

Clinical trial_TMF file

Immunotherapy clinical trial

Both studies demonstrated a highly favourable safety profile with zero treatment related serious adverse events and showed a significant decrease in both new lesions and lesion volume, as well as a significant improvement in cognition. 

The results of the two open-label trials were recently reported in one of the world’s most widely read and highly cited peer-reviewed neurology medical journals – Neurology.

Keith Martin, CEO of Apitope, said: “We are delighted that these data have been published in Neurology, a premier peer-reviewed journal for clinical neurologists.  ATX-MS-1467 is the first potential therapeutic for multiple sclerosis that has the potential to combine high efficacy with an excellent, and thereby differentiating, safety profile.”

No changes in EDSS and MSFC scores from baseline to the end of treatment were observed although there was a strong trend for improvement in MSFC (p=0.054).

The paper concluded that relatively slow ATX-MS-1467 titration and a longer full-dose intra-dermal treatment period is associated with reduction in gadolinium enhancing lesions and a sustained effect post-treatment. As a result it was deemed that further trials of ATX-MS-1467 are warranted.

Dr Jeremy Chataway, Lead author and Consultant Neurologist National Hospital for Neurology and Neurosurgery and Reader in Neurology, University College London, said: Apitope’s antigen-specific immunotherapy approach, to reinstate tolerance to the protein causing the disease, represents a major conceptual shift away from most current and emerging immunomodulatory therapies for multiple sclerosis.  The results from a phase 1b and phase 2a study outlined in the Neurology publication, further support ATX-MS-1467 as a potentially effective and well-tolerated new therapy.”

Multiple sclerosis

Multiple sclerosis is considered an autoimmune disease which involves progressive damage to the central nervous system.

An autoimmune disease occurs when the immune system  mounts an undesired response to an innocuous self-antigen and attacks healthy tissues in the body.

Autoimmune diseases are typically treated with therapies that globally suppress the immune system.