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Anti-TB substance BTZ-043 passes Clinical Trial Phase Ia milestone
Gera, Germany: – The partners involved in the development of the new innovative anti-tuberculosis agent API BTZ-043 have disclosed that Clinical Phase Ia studies now finalized.
Clinical Phase Ia was conducted at a study center in Germany during 2018 and was finally completed in March this year. The complete synthesis development for the tested API was done at HAPILA, which has also been granted Good Manufacturing Practice (GMP) certification for manufacturing BTZ-043.
Double blind randomized trial
The clinical studies were sponsored by the hospital of the Ludwig-Maximilians-Universität (LMU) Munich. The study was a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate safety, tolerability, and pharmacokinetics of single doses of BTZ-043 in healthy adult volunteers. Cohorts were formed from 30 male and female participants, with each cohort consisting of subjects assigned to BTZ-043 and to placebo.
Objective were to evaluate the safety and tolerability of BTZ-043 in a dose range around a likely therapeutic dose, given orally, as measured by clinical observations, vital signs, safety laboratory and electrocardiogram assessments and to describe the pharmacokinetics of BTZ-043 after a single dose.
The tested single oral doses of BTZ-043 were safe and well tolerated. There were no serious adverse drug reactions and no subject discontinued the study due to adverse event. All treatment emergent adverse events were of mild or moderate intensity. BTZ-043 was rapidly absorbed, metabolized and eliminated.
BTZ-043 belongs to a new class of antibiotics, the benzothiazinones. As the representative of this family of substances, BTZ-043 was the first to gain worldwide patent protection for its effect against the pathogen causing tuberculosis. It is also effective against highly resistant strains of tuberculosis.
Following discovery of the active pharmaceutical ingredient at The Leibniz Institute for Natural Product Research and Infection Biology – Hans-Knöll-Institute (HKI) in Jena, a team of scientists and entrepreneurs has been involved in developing BTZ043 as a tuberculosis medication as part of a partnership involving Leibniz HKI, the hospital of the LMU and the InfectControl 2020 consortium and DZIF research agency, initiated and supported by Germany’s Bundesministerium für Bildung und Forschung [Federal Ministry for Education and Research].
API development milestone
HAPILA CEO, Dr Uwe Müller, commented: “This latest milestone further underlines HAPILA’s credentials as a highly competent partner for API development as part of our customers’ drug product development strategies, starting with synthesis development, providing material including the required documentation for clinical studies 1 through 3 and also market supply.
“We are also showing that we can fulfill the requirements for manufacturing active pharmaceutical ingredients according to the guidelines of GMP Part II for API manufacturing, verification and release,” said Dr. 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 at 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.