SynOx Therapeutics Limited, a late clinical-stage biopharmaceutical company developing a novel treatment for CSF-1 related and macrophage-driven disorders, announced the appointments of Elyse Seltzer, M.D., as Chief Medical Officer (CMO).
These strategic hires come at a pivotal time as SynOx accelerates the clinical development of emactuzumab, a potentially best-in-class CSF-1R inhibiting monoclonal antibody. The company recently announced that the first patients have been dosed in its Phase 3 registrational study of emactuzumab for the treatment of Tenosynovial Giant Cell Tumours (TGCT).
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Dr. Seltzer brings more than 20 years of expertise in clinical development and regulatory strategy across various therapeutic areas to SynOx. She most recently served as a Senior Therapeutic Subject Matter Expert at Biomedical Advanced Research and Development Authority (BARDA), where she supported collaborations between the U.S. government and biotech and pharmaceutical companies on treatments for emerging infectious diseases and acute respiratory distress syndrome (ARDS).
Previously, Dr. Seltzer held key leadership roles including Chief Development Officer at Urogen Pharma, where she oversaw the development and approval of Jelmyto® for urologic oncology, and Chief Medical Officer at Nabriva Therapeutics, where she led the successful development of Xenleta®, approved for the treatment of community-acquired bacterial pneumonia. SynOx believes that Dr. Seltzer’s strategic experience, which spans early-stage research to late-stage clinical trials and commercialization, will be instrumental in advancing the company’s clinical programs, including the recently initiated Phase 3 TANGENT trial for emactuzumab in TGCT.
SynOx recently announced the initiation of the TANGENT study, a global, multi-centre, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the efficacy and safety of emactuzumab in patients with TGCT. The study’s primary outcome measure is overall response rate (ORR). Investigators will also assess several secondary outcomes including functional and quality of life measurements, impact on tumour volume, and duration of response. Investigators expect to enrol approximately 130 patients in the trial. Additional study details can be found on ClinicalTrials.gov.
SOURCE: GlobeNewswire