By HAPILA GmbH
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HAPILA’s BTZ-043 anti TB agent commences human trials
Gera, Germany: – High-potency active ingredient specialist CDMO HAPILA GmbH (HAPILA) has announced the commencement of Clinical Phase II trials for its promising anti-tuberculosis API BTZ-043.
Since mid-November TB patients have been treated for the first time with the new substance BTZ-043 in Cape Town, South Africa. The study is being carried out under the sponsorship of the Ludwig-Maximilians-Universität (LMU) Munich, represented by Prof. Michael Hoelscher.
The study is being conducted in the PanACEA consortium in collaboration with the TASK Applied Science Clinical Research Center, the University of Cape Town Lung Institute (UCTLI) and the Radboud University Medical Center.
This is a prospective, open label, two-center, randomized, controlled, two-stage, phase Ib/IIa study to evaluate the safety, tolerability, Pharmacokinetics, drug-drug interaction and bactericidal activity of BTZ-043 administered orally once daily over 14 days to participants with newly diagnosed, uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis.
The primary objective is to assess the safety and tolerability of BTZ-043 given over 14 days by evaluation of adverse events during treatment and follow-up period in patients with newly diagnosed, uncomplicated, smear-positive, drug-susceptible pulmonary tuberculosis.
In mid-November 2019, the first tuberculosis patients for treatment with BTZ-043 were included in the study. First results on tolerability and efficacy are expected by the middle of next year.
Combating highly resistant TB strains
BTZ-043 was first discovered at the Leibniz Institute for Natural Product Research and Infection Biology, Hans-Knöll-Institut (HKI). It is also effective against highly resistant strains of tuberculosis, which is the most common cause of death worldwide caused by bacterial infections.
HAPILA undertook complete synthesis development for the tested API as well as its cGMP manufacturing, according to the Guideline of Good Manufacturing Practice, Part II – API (Manufacturing, Verification and Release).
The consortium InfectControl 2020 and the German Center for Infection Research (DZIF) support most of the studies as well as the Thüringer Aufbaubank for API development effort.
“A Phase I study conducted in Germany showed good tolerability of BTZ-043. If BTZ-043 proves to be safe and effective in the current study (Phase II), this would be a major step in the development of a new drug,” commented HAPILA CEO, Dr. Uwe Müller.
About HAPILA GmbH
HAPILA GmbH is a Contract developer and manufacturer (CDMO) that provides high-value services to pharma, biotech and fine chemicals client companies in the development and cGMP manufacture of active pharmaceutical ingredients (APIs).
HAPILA is an independent company with particular experience in GMP-related development and GMP manufacturing, offering full regulated service for API (IMPD, ASMF) to very high scientific and quality assurance (QA) levels.
It supports the development and manufacture of drug products with patented processes and in-depth experience in the API value-creation chain from synthesis through purification to particle design.
The company’s mission is to supply exclusive products of highest quality, potency and safety in compliance with GMP and environmental protection guidelines. All HAPILA teamwork is focused on product quality and customer satisfaction.
All HAPILA chemical synthesis is carried out in-house at its GMP certified laboratories at Gera, Thuringia, in east-central Germany.
When combined with purification and particle design, HAPILA’s chemical synthesis services cover the complete API value-creation chain, enabling it to be a highly efficient bridge-builder between API production and pharmaceutical end-use.
Click on New drug substance BTZ-043 is being tested on patients for the first time for LMU news release.
Click on NCT04044001 for Phase II trial listing.