HAPILA GmbH has overcome global supply disruptions to complete its synthesis campaign to produce the required 150 kilos of its innovative anti-tuberculosis antibiotic candidate BTZ‑043.
This keeps the BTZ-043 program on track for its clinical trials, with the API produced in the quantities needed to support Clinical Phase IIb trials on dose-ranging, as well as for tox-studies.
BTZ-043 is a small molecule API that has been identified as effective against highly resistant strains of tuberculosis, the most common cause of death worldwide caused by bacterial infections. It was named ‘Drug of the Year’ by the Leibniz Wirkstofftage, the Leibniz Research Network Bioactive Compounds at its 2023 conference in Braunschweig, Germany.
A Phase I study conducted in Germany showed good tolerability of BTZ‑043. Proving BTZ‑043 to be safe and effective in the current study Phase IIb would be a major step towards market launch as a tuberculosis drug.
The 150 kg of BTZ‑043 was the amount HAPILA was required to produce to support the clinical trials to meet its CDMO responsibilities.
Due to global supply difficulties, the biggest challenge for HAPILA has been to procure suitable starting materials in the required quantities for the GMP-synthesis.
HAPILA has undertaken complete synthesis development for BTZ‑043 as a tested and usable API as well as cGMP manufacturing to comply with guidelines covering Part II – API (Manufacturing, Verification and Release).
