RemeGen, a commercial-stage biotechnology company, has enrolled its first patient onto the clinical trial testing the safety and efficacy of telitacicept for generalised myasthenia gravis.
The global trial will test the company’s BLyS/APRIL dual-targeting fusion protein drug, and will be run over a number of locations in the region.
Telitacicept has previously been granted orphan drug status by the US Food & Drug Administration (FDA), while also receiving fast track designation and breakthrough therapy designation by the National Medical Products Administration (NMPA) of China.
Catering to unmet patient needs
The multi-centre, randomised and double-blind phase III study will evaluate the safety and efficacy of telitacicept when treating generalised myasthenia gravis.
The initiative aims to recruit at least 180 patients from multiple regions globally.
Myasthenia gravis is chronic and rare autoimmune disease that results in the inefficient transmission of nervous impulses at neuromuscular junctions, which can impact eye movement, swallowing, speech and respiratory function.
There is currently a significant unmet need in this patient population owing to the lack of tolerability in some patients for the drugs currently available on the market.
Telitacicept was designed as a dual targeting antibody fusion protein, which can directly interact with the source of pathogenic B-cells and plasma cells, which reduces the production of these overactive immune cell forms.
Preliminary clinical studies have — so far — suggested the drug’s efficacy in improving the clinical status of patients with generalised myasthenia gravis.
