Atox Bio

Company Overview

Snapshot

Founded in May 2003 by Gila Arad and Raymond Kaempfer, Atox Bio operated with 11–50 employees. The company raised $64.85 million across 5 funding rounds from 10 investors. In May 2022, the company ceased operations after failing to secure FDA approval for its lead drug.

Business overview

Atox Bio was a late-stage biotechnology company focused on developing novel immunomodulators for critically ill patients. Its core product, Reltecimod, was being developed to treat necrotizing soft-tissue infection (NSTI), a severe and life-threatening condition without existing therapies. The company operated within the Health Tech & Life Sciences sector, specifically in Pharma & Medical Biotechnology and Drugs Discovery & Development, targeting healthcare providers and patients.

Strategic signal

In May 2022, Atox Bio ceased operations following the FDA's request for an additional clinical trial for Reltecimod, which the company deemed unfeasible due to high costs and extended timelines. This event signals a critical challenge in the biotechnology sector, highlighting the significant financial and regulatory hurdles faced by companies developing novel therapies, even after extensive clinical development and prior FDA acceptance for review.

Company Intelligence Q&A

What was the primary reason for Atox Bio ceasing operations?

Atox Bio ceased operations in May 2022 after the FDA requested an additional clinical trial for its drug, Reltecimod. The company determined that conducting this trial was not feasible due to the high cost and lengthy duration involved.

What was the status of Reltecimod's FDA application prior to the company's closure?

In December 2020, the FDA accepted to file the New Drug Application (NDA) for Reltecimod.

What were the results of the Phase 3 ACCUTE trial for Reltecimod?

In July 2020, Atox Bio announced positive results from its Phase 3 ACCUTE trial, showing a significant difference in the percentage of patients administered Reltecimod who achieved resolution of organ dysfunction/failure by Day 14, compared to those who received a placebo.

Which organization supported the development of Reltecimod?

In June 2019, the Biomedical Advanced Research and Development Authority (BARDA) exercised an option to support the continued development of Reltecimod for NSTI, bringing their total commitment to $22 million.

When did Atox Bio secure its last disclosed funding round?

In December 2017, Atox Bio secured an investment round led by.