Arix Bioscience PLC (LON:ARIX) has said its portfolio company, Atox Bio, is planning to submit a new drug application (NDA) to the US Food and Drug Administration (FDA) for its Reltecimod drug in the third quarter of 2020 under an accelerated approval pathway.
The plans follow results from a phase 3 clinical trial of Reltecimod which showed positive effects on resolution of organ dysfunction in patients suffering with necrotizing soft tissue infection.
The Phase 3 results showed that Atox’s Reltecimod, in conjunction with currently available standard of care demonstrated, a “significant difference” in the percentage of patients who achieved resolution of organ dysfunction/failure by day 14 versus standard of care alone.
Atox added that Reltecimod was “well-tolerated” in patients, who also demonstrated an improvement in hospital discharge status versus a placebo.
Arix Bioscience shares were 0.6% higher at 87p in early trading on Friday.
Published at Fri, 10 Jul 2020 07:52:00 +0000-Arix Bioscience says portfolio company Atox Bio plans NDA submission for Reltecimod drug in third quarter of 2020