SynOx Therapeutics Completes Enrollment in Registrational Phase 3 TANGENT Clinical Trial Significantly Ahead of Timeline
Top-Line Results from Study Evaluating Emactuzumab for Tenosynovial Giant Cell Tumours (TGCT) Expected in First Quarter of 2026
DUBLIN, IRELAND, OXFORD, UK, and PHILADELPHIA, PA – August 5, 2025
SynOx Therapeutics Limited (“SynOx”), a late-stage clinical biopharmaceutical company developing emactuzumab for Tenosynovial Giant Cell Tumours (TGCT), today announced completion of patient enrolment in the TANGENT study. TANGENT is the company’s global, multi-centre, randomized, double-blind, placebo-controlled registrational Phase 3 trial of emactuzumab in patients with TGCT who are not amenable to or who would not benefit from surgery. SynOx expects to report top-line data from the study in the first quarter of 2026.
Emactuzumab is a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody (mAb). Clinical evaluation to date has demonstrated the compound to be a promising, next-generation mAb therapy with the potential to offer a short treatment cycle, rapid onset and long duration of response that differentiates it from chronically administered oral agents. This potentially best-in-class profile helped drive strong interest in the TANGENT trial among patients and clinical investigators across sites in the United States, Canada, Europe and Asia, leading to rapid study enrollment.
“Completion of enrollment in our registrational TANGENT trial marks an important milestone for SynOx and for the TGCT community,” said Elyse Seltzer, M.D., Chief Medical Officer of SynOx Therapeutics. “We are deeply grateful to the patients, families, investigators, and clinical sites whose dedication has made this study possible and allowed SynOx to fully enroll the trial significantly ahead of our projected timeline. We remain committed, data permitting, to delivering a much-needed new treatment option for this debilitating condition.”
“This is a transformational time for SynOx as we advance emactuzumab through its pivotal Phase 3 program,” said Ray Barlow, Chief Executive Officer of SynOx. “We’re excited about the next steps and look forward to delivering top-line data that we hope demonstrate how emactuzumab can transform care for patients with this grievous disease.”
About the TANGENT Study
TANGENT (ClinicalTrials.gov Identifier: NCT05417789) is a randomized, double-blind, placebo-controlled Phase 3 trial evaluating the efficacy and safety of emactuzumab in patients with TGCT who are not amenable to or would not benefit from surgery. Patients who consent and meet eligibility criteria are randomized in a 2:1 fashion to receive either emactuzumab (1000 mg every two weeks for five doses) or matched placebo.
The primary endpoint is objective response rate (ORR) as assessed by RECIST criteria at six months post-randomization. Key secondary endpoints include patient-reported outcomes (PROMIS-PF), functional assessments of range of motion, pain, stiffness, durability of response, and safety. Patients are followed for two years from randomization, with those demonstrating disease progression after the six-month assessment eligible to receive open-label emactuzumab during follow-up.
For the full press release see here: SynOx Completion of TANGENT Study PR
