During the 2023 American Society of Clinical Oncology (ASCO) meeting, EpicentRx, Inc., a clinical-stage biopharmaceutical company, provided updates on the clinical progress of its two main oncology treatment candidates, RRx-001 and AdAPT-001.
EpicentRx presented the Phase IIb KEVLARx study design for RRx-001, which has received FDA Fast Track designation. The study is focused on the treatment of severe oral mucositis and is based on data obtained from the previous Phase IIa PREVLAR study.
Additionally, the company presented encouraging initial data for AdAPT-001, a vector that acts as a trap for transforming growth factor beta (TGFβ). This marks the first time such data has been obtained in humans, demonstrating the potential of AdAPT-001 as a therapeutic option.
Overall, EpicentRx showcased advancements and updates for both RRx-001 and AdAPT-001 during the ASCO meeting.
“What patients need is not the ‘same old, same old’ but potentially well-tolerated, novel therapies like RRx-001 and AdAPT-001 that work differently to harm diseases, not the patients with these diseases,” said Tony Reid, Chief Executive Officer of EpicentRx. “With a growing body of data and our recent FDA Fast Track Designation of RRx-001 and positive Phase 1 data for AdAPT-001, EpicentRx is well positioned to move our pipeline forward and demonstrate success in additional disease indications.”
After the positive results of the Phase 2a PREVLAR study, EpicentRx received Fast Track designation from the U.S. Food and Drug Administration (FDA) for their drug candidate, RRx-001. This designation aims to accelerate the development and review process of RRx-001. Additionally, the FDA granted regulatory approval for a follow-on Phase 2b study of RRx-001, called KEVLARx, which will be conducted at multiple centers. Detailed information about this study was presented at the ASCO Annual Meeting (Abstract 416822).
Data from the previous PREVLAR trial demonstrated that administering only four doses of RRx-001 before chemotherapy and radiation, a convenient and straightforward approach for both patients and physicians, resulted in a delay in the onset, reduced the severity, and shortened the duration of severe oral mucositis (SOM) in patients with locally advanced head and neck cancer.
Source: EpicentRx, Inc
