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ASIT Biotech launches its confirmatory phase III clinical trial using gp-ASIT +

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( – ASIT biotechnology, a Belgian biopharmaceutical company specializing in the research and development of innovative immunotherapy products in the treatment of allergy, announced today that it held an investigative meeting in Prague (Czech Republic) on November 16-17, 2018, confirming the phase III clinical trial with ASIT + in the prevention of allergic catarrh of grass pollen.

A meeting of investigators gathered 142 participants, including a team of researchers, the ASIT clinical biotechnology team, a contract research team (CRO), which will coordinate the study, ICON plc, and as various service providers. The main objective of the meeting was to establish the principles of effective communication, clearly defining the role and responsibilities of each participant and sharing detailed information about the clinical trial in order to effectively manage its progress.

To cope with the challenges of clinical development in this indication, such as overweight of the center or country, no pollen or unused pollen traps, choice of patients with low levels of allergies and suboptimal data on drug use and symptoms due to unreliable patient reporting, biotechnology ASIT made 9 significant improvements, based on the conclusions drawn from the first phase of the Phase III clinical trial conducted in this indication:

A new Phase III study is commissioned to subcontractors by one CRO, ICON plc, which has extensive experience in allergy research.

Supervision is performed internally by a proven clinical operating team, consisting of a team leader who has 30 years of clinical development experience, a medical director who has 30 years of clinical development experience, and two clinical project leaders each with 10 years of experience in clinical development.

Clinical centers were selected on the basis of their historical high pollen rates and their ability to ensure data quality registration.
To avoid problems related to the recruitment and overweight of one center or country, 82 clinical centers in 6 countries (Germany, Belgium, France, the Czech Republic, Hungary and Poland) are involved in this phase III clinical trial. and the number of patients randomly drawn to the center is limited.

To draw the most allergic patients, only patients with moderate to severe medical history will be selected in the last two years.

Recruitment on every clinical site is tracked online, based on an anticipated schedule based on pollen data from previous generations over the last 5 pollen season.

Electronic magazines are used instead of paper journals to significantly improve data quality and patient registration.
Monitoring pollen levels is centralized by the European Aeroalergen Network at the University of Vienna to ensure the reliability of data on pollen levels used for statistical analysis.

The earlier launch compared to the first phase III trial will extend the period of randomization and treatment before the grass pollen season begins.

The study plans to employ 624 patients allergic to grass pollen, compared to 554 patients in the first phase III study. The first visit of the first patient is planned for January 2019. The last visit to the patient in September 2019, the Company may obtain the results of the study in December 2019.

The main goal of the study was to reduce by 20% the total score of clinical symptoms and treatment results (CSMS) in the treatment group compared to the placebo group (absolute difference between the treatment group and the placebo group). at least -0.30).

As agreed with the German health ministry Paul-Ehrlich-Institut (PEI) at the scientific meeting in June 2017, in the case of conclusive results from the new phase III trial, IAP may allow ASIT biotechnology applying for a marketing authorization (MA) in Germany, with the possibility of extending this marketing authorization to other European countries in accordance with international guidelines.

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