Janssen reports positive data for myasthenia gravis treatment

Monoclonal antibody

Janssen-Cilag has reported positive results from its Phase III Vivacity-MG3 study assessing its nipocalimab therapy for the treatment of patients with generalised myasthenia gravis (gMG).

The Johnson & Johnson company showcased the data in a presentation at the European Academy of Neurology (EAN) 2024 Congress and plan to submit the data to regulatory authorities later this year.

Myasthenia gravis (MG) is a rare condition that causes muscle weakness and can be characterised by symptoms such as limb weakness, drooping eyelids, double vision, and difficulties with chewing, swallowing, speech, and breathing. Whilst the disease can be managed with current therapies, there is currently an effort to develop new treatments for patients who don’t respond well or can’t tolerate existing therapies.

The data show that patients treated with nipocalimab plus standard of care (SOC) achieved superiority over placebo plus SOC as measured by the primary endpoint of improvement in the Myasthenia Gravis – Activities of Daily Living (MG-ADL) score from baseline over 24 weeks.

The Phase III Vivacity-MG3 study

The Vivacity-MG3 study enrolled 199 patients with specific antibodies – anti-acetylcholine receptor positive antibody (AChR+), anti-muscle specific tyrosine kinase positive antibody (MuSK+) and/or anti-low density lipoprotein receptor-related protein 4 positive antibody (LRP4+) – which account for around 95% of the gMG patient population.

Among this cohort, 77 patients receiving nipocalimab plus the SOC treatment improved by 4.70 points on the MG-ADL score versus baseline. This was compared to the 3.25 point improvement versus baseline observed with placebo plus SOC seen by 76 patients.

For someone living with gMG, this point may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and being on a ventilator.

The study also saw secondary endpoints such as improvement in strength and function of muscle groups be met.

“The sustained response of nipocalimab over six months among this broad myasthenia gravis population is an important finding given the chronic, unpredictable exacerbations typically seen with myasthenia gravis,” said Carlo Antozzi, Neuroimmunology and Muscle Pathology Unit of the Neurological Institute Foundation C Besta of Milan, Italy. “We are encouraged by the potential of nipocalimab to uniquely address this gap for people living with myasthenia gravis.”

“We are committed to leading where medicine is going in the autoantibody diseases space,” said Ludovic de Beaucoudrey, Senior Director, Therapeutic Area Lead, Immunology, Janssen-Cilag. “We are excited by the potential clinical benefit of nipocalimab in generalised myasthenia gravis and with these promising results, we are one step closer to bringing this innovative treatment option to people living with this devastating condition.”

Reece Armstrong, Editor, DDW

Related Articles

Join FREE today and become a member
of Drug Discovery World

Membership includes:

  • Full access to the website including free and gated premium content in news, articles, business, regulatory, cancer research, intelligence and more.
  • Unlimited App access: current and archived digital issues of DDW magazine with search functionality, special in App only content and links to the latest industry news and information.
  • Weekly e-newsletter, a round-up of the most interesting and pertinent industry news and developments.
  • Whitepapers, eBooks and information from trusted third parties.
Join For Free