Arix Bioscience notes Atox Bio’s new drug application for Reltecimod
(LON:ARIX ) said its portfolio company, Atox Bio, is planning to submit a New Drug Application to the US FDA for its Reltecimod drug in the third quarter of 2020.
The global venture capital firm said Atox Bio would submit the application under ‘Accelerated Approval Pathway’ which allows for earlier approval of drugs that treat serious conditions.
The decision follows results from a phase 3 clinical trial of Reltecimod which showed positive effects on resolution of organ dysfunction in patients with necrotizing soft tissue infection.
Reltecimod is designed to enhance resolution of organ failure in conditions associated with severe, acute inflammation such as Necrotizing Soft Tissue Infection (NSTI) and sepsis.
“This is a potentially life-threatening condition with significant morbidity and long-term mortality that has no FDA-approved treatment.” said Dan Teleman, CEO of Atox Bio.
Shares in Arix Bioscience opened flat at 86.5p on in early trading on Friday morning.
The Phase 3 results showed that Reltecimod, in conjunction with the 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.
The group added that Reltecimod was ‘well tolerated’ in patients who also demonstrated an improvement in their hospital discharge status versus those taking a placebo.
“Reltecimod has been designed to modulate rather than completely suppress acute inflammation that can lead to a dysregulated immune response and we are actively working to bring this important new potential therapy to patients,” added Teleman.
Arix Bioscience led an oversubscribed $30 million Series F financing round for Atox Bio in December 2017 where the company invested $8 million in return for an equity stake.
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