Momenta confirms its place in FcRn race

A successful mid-stage read out from Momenta’s anti-FcRn project, nipocalimab, confirms that the project is a viable competitor in this closely watched novel mechanism. The Vivacity-MG study compared four different dosing schedules of the antibody against placebo in patients with advanced myasthenia gravis (MG), an IgG-driven autoimmune condition. The primary efficacy endpoint was change on a symptom scale called MG-ADL, and when pooled across the arms the placebo-adjusted response rate came out remarkably close to that achieved by Argenx last month with its leading anti-FcRn project, efgartigimod: 36.5% vs 40% respectively. Safety also looked clean, reassuring given some signals seen in phase I; Momenta shares jumped 15% on the news. Seeking a competitive edge the company hopes to take monthly or longer dosing into phase III trials, which are slated to start later this year. Subcutaneous delivery remains the real goal, however, and both Argenx and Momenta are working on switching to SC from their current IV formulations. One wild card here is Immunovant, which is gearing up to release phase IIa data on its SC project, IMVT-1401, in the coming months.

FcRn targeted projects: the progress so far
Project Pharmacology Company Next steps 
Efgartigimod Anti-FcRn Ab fragment; IV and SC in earlier development  Argenx US filing due by year end 
  Rozanolixizumab Anti-FcRn MAb; SC UCB Phase III readout expected H1 2021


Anti-FcRn MAb; IV and SC in earlier development Momenta Phase II MG trial positive, phase III to start by YE'20
IMVT-1401 Anti-FcRn MAb; SC Immunovant/ Hanall Biopharma/ Harbour Biomed Phase IIa in MG read-out Q3'20; thyroid eye disease over next 12 mth
ALXN1830 Anti-FcRn MAb; IV and SC in earlier development  Alexion (Syntimmune) Paused owing to Covid-19, to restart 2021, SC formulation prioritised
ABY-039 Anti-FcRn bivalent Ab mimetic; SC Affibody Alexion handed back rights in Feb 2020; phase I ongoing
Source: EvaluatePharma, company statements. 

Vivacity-MG phase II trial

Momenta presentation

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