BRIEF—Efgartigimod in PC-POTS is not clinically meaningful

Dutch autoimmune diseases specialist Argenx announced that results from the Phase II ALPHA study of efgartigimod in post-COVID-19-mediated postural orthostatic tachycardia syndrome (PC-POTS) show that treated patients had no clinically meaningful improvement compared to placebo on the total Malmö POTS symptom (MaPS) score and COMPASS31.

The observed safety and tolerability profile of efgartigimod in the ALPHA study was consistent with previous clinical trials.

However, argenx said it will not move forward with development in PC-POTS and instead plans to prioritize resources to the nearly 50 active clinical trials in its expanding pipeline.

Key details remain unknown regarding the outcomes of the Phase II ALPHA study, designed to establish proof-of-concept of efgartigimod in PC POTS.

The magnitude of efficacy on key endpoints, including the total Malmö POTS symptom (MaPS) score and COMPASS31, was not disclosed beyond the not clinically meaningful characterization.

Marketed under the brand name Vyvdura, efgartigimod has gained regulatory approval in a number of geographies for the treatment of generalized myasthenia gravis (gMG).