Phase I/II of Roche PNH candidate temporarily halted

Chugai Pharmaceutical Co. Ltd. (Tokyo:4519) said enrollment was temporarily stopped in the Phase I/II COMPOSER trial evaluating RG6107 (SKY59) in healthy volunteers and patients with paroxysmal nocturnal hemoglobinuria (PNH) after two patients who received RG6107 developed mild to moderate symptoms of immune-mediated hypersensitivity.

The company said enrollment and dosing in the trial have been restarted after both events were determined by the investigator to be non-serious. Both patients have since recovered from the events and have been re-dosed without any clinical sequelae. Chugai added that the adverse reaction was not unexpected and was included as a potential complication in patients' informed consent...