Quratis' novel TB vaccine confirms safety, immunogenicity in phase 2 study
22 May 2023 -- Quratis said on Monday that the phase 2a clinical trial results of its novel tuberculosis (TB) vaccine for adults and adolescents, QTP101, showed excellent safety and immunogenicity.
The phase 2a trial was conducted on 107 healthy adults with a
history of Bacillus Calmette–Guérin (BCG)
immunization at Severance Hospital, Chung-Ang University
Hospital, and Ajou University Hospital.
Accordingly,
the QTP101 TB vaccine group demonstrated clinically and
statistically significant increases in antigen-specific antibody
levels and Type 1 T-helper cell immune responses compared to the
control group. Furthermore, the study showed that immune
responses were sustained for 12 months.
Regarding
safety, no serious adverse events or deaths leading to treatment
discontinuation were reported and the drug was clinically
well-tolerated.
Based on the results, Quratis
submitted an investigational new drug (IND) plan to the Ministry
of Food and Drug Safety (MFDS) for a multi-country phase 2b/3
serialized clinical trial of the QTP101 TB vaccine and received
approval for the clinical trial plan in July of last year.
The
phase 2b/3 clinical trial aims to demonstrate long-term safety
and evaluate immunogenicity and efficacy in a large cohort of
healthy adolescents and adults.
"This publication
recognizes the excellent safety and immunogenicity of our QTP101
TB vaccine," said Quratis’ Managing Director Choi Yu-hwa,
who led the clinical trial. "We are in the final stages of
clinical development, and if we are successful in
commercializing our TB vaccine for adolescents and adults, we
will be able to enter the market as a leader."
Choi
added that the multi-country phase 2b/3 late-stage clinical
trials will enable the company to be the first in the world to
commercialize and compete with next-generation TB vaccines, to
help end TB globally.
Based on the Global TB Report
2022 published by the World Health Organization (WHO),
approximately 10.6 million people contracted TB in 2021, a 4.5
percent increase from 2020. The annual number of TB deaths has
been declining since 2005 but has been on the rise, increasing
from 1.4 million in 2019 to 1.5 million in 2020, further
increasing 14 percent to 1.6 million in 2021, marking the second
consecutive year of growth.
According to WHO, the
global value of new TB vaccines is estimated at $37.2 billion
for adolescent and adult vaccines.
The results of the
study were
published
in the Infectious Diseases and Therapy journal.
Source:
Korea Biomedical Review
