Telacebec Achieves 100% Cure Rate in All 40 Patients
FDA Approval and Priority Review Voucher (PRV) Timeline Becoming Clear
Innovative new drug developer Qurient announced on October 23 that it had presented the initial results of the Australian regulatory clinical trial (TREAT-BU) for Telacebec in Buruli ulcer patients at 'ID Week 2025,' held in Atlanta, USA, from October 19 to 22 (local time).
ID Week is a major annual academic conference in the field of infectious diseases, jointly hosted by five leading societies, including the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), and the HIV Medicine Association (HIVMA), and covers the latest research and innovations in infectious diseases.
Daniel O'Brien, M.D., of Barwon Health in Australia, who serves as the principal investigator (PI) for the clinical trial in the United States, presented the findings on site. The final results showed that all 40 patients who participated in the trial achieved a 100% cure rate. This officially confirms a "100% cure" rate, surpassing the "virtually 100% cure" data presented at the World Health Organization (WHO)-organized international conference in March. At that time, 34 out of 40 patients had been cured, while the remaining patients were still undergoing re-epithelialization of their lesions. Final follow-up confirmed that all patients were healed without recurrence.
The 'TREAT-BU' clinical trial is a regulatory trial being conducted at two medical institutions in Australia. The clinical design uses 'complete healing' of lesions up to 52 weeks as the primary endpoint, and if the trial is successfully completed, full regulatory approval will be possible. Last year, the trial began with 40 initial patients who received a once-daily 300 mg dose of Telacebec for four weeks as monotherapy. This year, an additional 80 patients are being enrolled under the same design.
In the clinical trial, Telacebec demonstrated excellent safety and tolerability. All patients completed the four-week treatment without discontinuing the drug or dropping out. No serious adverse events (SAEs) were reported, and all reported adverse events were mild.
Currently, there is a WHO-recommended treatment for Buruli ulcer, but it requires the use of multiple antibiotics over an extended period, which leads to side effects, reduced medication adherence, and delayed wound healing. As a first-in-class antibiotic, Telacebec has demonstrated the potential to reduce side effects, improve convenience, and shorten the treatment period by proving a cure with only four weeks of monotherapy.
A Qurient official stated, "With the encouraging initial results of all 40 patients being cured, we expect the same consistent results to be reproduced in the ongoing expanded trial with 80 patients under the same clinical design." The official added, "Once the FDA approval timeline becomes more concrete based on the clinical data, Qurient will not only become the first domestic company to successfully develop a first-in-class new drug, but will also clarify the timeline for securing a Priority Review Voucher (PRV)."
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