A Phase III study of Chugai Pharmaceuticals’ Enspryng (satralizumab) in generalised myasthenia gravis (gMG) has not met the company’s expectations, despite achieving its primary endpoint.
The Roche subsidiary’s Phase III Luminesce trial (NCT04963270) showed statistically significant data in the primary endpoint but results did not reach expectations on the degree of clinical benefit.
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More detailed data from the Luminesce study will be presented at the 76th American Academy of Neurology (AAN) 2024 annual meeting in Denver, Colorado, from 13 to 18 April 2024.
The global, multicentre, randomised, trial evaluated the efficacy and safety of Enspryng compared with placebo in 188 patients aged 12 and older with gMG. Patients received standard-of-care (SOC) therapy throughout the trial.
The primary endpoint was the mean change from baseline in total Myasthenia Gravis Activities of Daily Living (MG-ADL) score at 24 weeks in the anti-AChR-seropositive (AChR+) population. This was measured by evaluating the impact on daily activities, including talking, chewing, swallowing, breathing, brushing teeth or hair, rising from a chair, double vision, and eyelid droop.
The safety profile for Enspryng remained consistent with that in neuromyelitis optica spectrum disorder (NMOSD) for which the candidate received approval in 2020.
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By GlobalDataDespite upset with the recent data, Japan-based Chugai said it will continue to investigate the candidate in additional neurological autoimmune and inflammatory diseases including autoimmune encephalitis (AIE), myelin oligodendrocyte glycoprotein-associated disorder (MOGAD) and thyroid eye disease (TED).
Enspryng is a humanised monoclonal antibody which targets Interleukin 6 (IL-6). The candidate binds to the soluble and membrane-bound IL-6 receptors and activates cells involved in immunological and inflammatory responses.
GlobalData predicts that global sales for Enspryng will reach $600m in 2030. GlobalData is the parent company of the Clinical Trials Arena.
gMG Landscape
gMG is a rare autoimmune and neuromuscular disease that affects most muscles throughout the body. gMG weakness can disrupt everyday activities including walking, chewing, and breathing.
GlobalData predicts the gMG market will generate sales of $6.7bn in 2032 across the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan).
Disease-modifying therapies (DMTs) in late-stage pipeline include Enspryng and Horizon Therapeutics’ Uplizna (inebilizumab). Marketed DMTs include Alexion’s Soliris (eculizumab), Argenx’s Vyvgart (efgartigimod alfa) and Alexion/AstraZeneca’s Ultomiris (ravulizumab). On 18 October 2023, the US Food and Drug Administration (FDA) cleared UCB’s ZILBRYSQ for generalised myasthenia gravis treatment.
By 2032, Alexion/AstraZeneca’s Ultomiris is expected to be the most profitable agent with sales of around $1.52bn, followed closely by Argenx’s Vyvgart and Vyvagrt Hytrulo with combined sales of $1.48bn.
