Phase 2 clinical trial results show potential to shorten TB treatment time with new antibiotic 

When contacted, Dr Vikas Oswal, consultant pulmonologist in Mumbai and Global Technical Expert member – Drug Resistant TB- Philippines, told The Indian Express that if SpaL proves safe and effective in both drug-resistant TB and drug-Sensitive TB, it could be a potential game-changer for treatment duration.

TB Alliance, a not-for-profit organization aimed at finding faster acting and affordable drug regimens to fight TB, is strengthening partnerships with high-burden countries such as India, China, Indonesia, South Africa and Brazil in advance of launching a Phase 3 clinical trial in 2026.

This upcoming trial is an opportunity to earn approval for a new drug and regimen, as well as the first step in the process of developing an ultra-short regimen, said experts at TB Alliance.

Dr. Mel Spigelman, President and CEO of TB Alliance said, “The development of the BPaL regimen, which combines antibiotics bedaquiline (B), pretomanid (Pa), and linezolid (L), allowed us to reduce treatment time for most drug-resistant TB to six months, a critical development for patients. Now, we have an opportunity to shorten treatment even further — representing an important milestone toward our goal of developing an ultra-short regimen capable of treating both drug-sensitive and drug-resistant TB.”

Sorfequiline and bedaquiline both belong to the diarylquinoline class of antibiotics, which target a key enzyme of the tuberculosis bacteria involved in energy production. In 2012, bedaquiline was approved for drug-resistant TB treatment, making it the first new antibiotic to be approved in decades. However, recent years have seen a rise in strains of TB that are resistant to bedaquiline. TB Alliance has been developing sorfequiline all the way through the R and D process, from early discovery to, now, late-stage clinical trials.

Trial results show that sorfequiline could have potentially a better safety profile than bedaquiline along with the potential to treat many of the strains that are resistant to bedaquiline. Sorfequiline has been developed in pill form, and SPaL will also be an all-oral TB treatment.

While Dr Oswal said that currently, there is no specific Indian data on outcomes of Sorfequiline in Indian TB patients yet, it is possible that India would participate in future studies or operational research once Phase-3 begins. The phase 2 trial was across 22 sites in South Africa, Philippines, Georgia, Tanzania and Uganda.

The 100 mg SPaL regimen had greater activity against TB than the standard of care HRZE (isoniazid, rifampin, pyrazinamide, and ethambutol), indicating the potential to shorten treatment time for active TB. In addition, the SPaL regimen had a comparable safety profile to the standard of care for people with drug-sensitive TB (DS-TB).