Qurient Expands Patient Recruitment for Telacebec Clinical Trial in Australia

PRV Value Expected to Rise with FDA Approval
Recently Traded at 220 Billion KRW

On July 9, innovative pharmaceutical company Qurient announced that it has begun recruiting an additional 80 patients for the Australian clinical trial of Telacebec for Buruli ulcer, following the initial cohort of 40 patients.

The company is extending the first phase of the clinical trial, which was conducted from July to December last year, while maintaining the same trial protocol and country as before. TB Alliance, the organization developing Telacebec, presented interim results from the first phase of the trial at a WHO international conference held in Geneva, Switzerland, in March. According to the announcement, the results showed an almost 100% cure rate with a short duration of administration, and demonstrated a high level of safety with virtually no side effects.

Given the drug's property of selectively targeting specific mycobacteria, the company expects that the expanded clinical trial will reproduce the same results.

Telacebec has been designated as an Orphan Drug by the U.S. Food and Drug Administration (FDA) for the treatment of Buruli ulcer. This designation allows for the possibility of submitting a marketing application based on relatively small-scale clinical data, providing advantageous conditions for the development and approval process.

A Qurient representative stated, "The interim results announced earlier this year have heightened expectations for the possibility of approval," and added, "If efficacy and safety are clearly reproduced in the expanded trial, we expect to secure key data for an FDA approval application."

The representative further commented, "At the time of new drug approval, the value of the Priority Review Voucher (PRV) is expected to rise further, exceeding 300 billion KRW."

As the sunset date (September 2026) for the Rare Pediatric Disease Program has been confirmed, expectations for supply reduction have increased, causing the value of PRVs to surge. Since the second half of last year, PRV prices have risen by about 70%, and are currently trading at around 160 million USD (approximately 220 billion KRW). In the past, there have been cases where PRVs were traded for as much as 350 million USD.