WE.SPEED.
In Ukraine alone, rare diseases like IPF affect 10-15 people out of 100.000 population, typically diagnosed in individuals over 40. Without treatment, life expectancy is no more than five years.
ARENSIA’s participation in a Phase IB study provided IPF patients access to a novel therapeutic approach using a recombinant, humanized, full-length IgG4 monoclonal antibody. This Single Ascending Dose (SAD) study featured a highly sophisticated design, particularly concerning the required pulmonary assessments.
Despite the study's complexity regarding patient population and design, ARENSIA’s clinic in Kyiv, Ukraine, enrolled 8 patients—one-third of the trial's total population of 24 patients—within [16] weeks. Another 12 clinical trial sites outside ARENSIA, including those in the UK, North Macedonia, and Turkey, collectively enrolled the remaining patients.
ARENSIA managed all required study procedures excellently, including the Diffusing Capacity of the Lungs for Carbon Monoxide assessments. The investigational product involved lengthy infusions of up to six hours, necessitating close monitoring. ARENSIA's dedication to patient safety and protocol adherence was evident throughout.
We are proud that ARENSIA played a crucial role in the trial's success, enabling the Sponsor to achieve its development milestone in a fast and efficient manner.
Alongside Ukraine, all ARENSIA research clinics in the USA, Romania, Bulgaria, Moldova, and Georgia are committed to advancing novel therapeutic options in respiratory diseases, with in-depth medical and operational expertise to accommodate sophisticated exploratory clinical trials requiring patients with asthma, COPD, and interstitial lung diseases.
ARENSIA’s unparalleled fast recruitment speed is complemented by the world's fastest regulatory approval timelines in the countries where we operate our clinics, ranging from 10 days in Moldova to 30 days in the USA, Ukraine, and Georgia, and 60 days in Romania and Bulgaria.
24.06.2024