At the recently held 2025 American Academy of Neurology (AAN) meeting, Remegen presented positive Phase III results for telitacicept in patients with AChR+ or MuSK+ generalised myasthenia gravis (gMG). The B cell-targeting therapy demonstrated a favorable efficacy and safety profile over 24 weeks, showing clinically meaningful improvement. These findings position telitacicept as a potential challenger to the existing disease-modifying therapies (DMTs), says GlobalData.
Telitacicept, given once weekly, demonstrated significant improvements in myasthenia gravis activities of daily living (MG-ADL) and quantitative myasthenia gravis (QMG) scores after just four weeks of treatment compared to placebo. The improvements were sustained through to week 24 of the trial. These data demonstrated that patients treated with telitacicept achieved clinically meaningful reductions in disease severity.
Telitacicept was also shown to be well-tolerated, with an overall adverse event (AE) incidence like that of the placebo group and an incidence of infection-related AEs that was lower than that of the placebo group.
Jos Opdenakker, Pharma Analyst at GlobalData, comments, “Displaying improvements in disease control, as measured by MG-ADL and QMG scores across a broad population that is seropositive for AChR or MuSK autoantibodies, is essential as most marketed therapies are indicated for AChR+ patients with gMG. As a DMT, telitacicept will be entering a highly competitive space in the market.”
According to GlobalData’s Drugs database, there are six DMTs currently marketed across the seven major pharmaceutical markets (7MM: The US, France, Germany, Italy, Spain, the UK, and Japan) for AChR+ patients. These include complement inhibitors and neonatal Fc receptor (FcRn) inhibitors, both of which are treatment pathways that are well-established in the MG treatment paradigm.
Opdenakker continues, “The late-stage pipeline (Phase IIb–III) is also crowded, with five other late-stage pipeline agents targeting both AChR+ and MuSK+ patients. Furthermore, there are also highly effective treatments for MuSK+ patients that are currently used off-label. Remegen will have to make an astute decision as to where it positions telitacicept in the MG treatment landscape.”
The key opinion leaders (KOLs) previously interviewed by GlobalData have noted that rituximab is a first-line treatment for patients who are MuSK+ and can induce complete remission in MG patients. If Remegen wants to position telitacicept as a first-line DMT for MuSK+ MG patients, it will be competing against the well-established rituximab, which is also available as a cheap biosimilar.
Opdenakker concludes, “With clinically meaningful improvements in MG-ADL and QMG scores, telitacicept offers hope for both AChR+ and MuSK+ patients. However, Remegen faces challenges as it enters a highly competitive market with established DMTs and several late-stage pipeline agents. Conducting head-to-head trials against these treatments can help telitacicept differentiate itself further. Telitacicept has the potential to become a valuable addition to the gMG treatment paradigm, offering new possibilities for disease management. Its success, however, depends on Remegen successfully navigating the complexities of market competition.”