Polish innovative asthma drug enters human trial phase

Polish innovative drug for asthma and other lung diseases enters clinical trials phase, ie. on humans, experts announced at a press conference in Warsaw. Later this week, the first patient will receive it, they pointed out.

– You are taking part in a historic event. This is the third time in the history of Poland that a Polish innovative drug is going to the phase of clinical trials – said during the meeting Undersecretary of State at the Ministry of Development Jadwiga Emilewicz, commenting on the fact that later this week the first group of volunteerow will receive a compound with the symbol OATD-01 from OncoArendi Therapeutics S.A.

Emilewicz noted that much of this type of research would not have been successful were it not for public funding. The work on the development of the new drug was a cooThe project is financed by the National Research and Development Center (NCBR) under the Programoin the Operational Programmes Innovative Economy and Intelligent Developmentoj. The deputy development minister recalled that in the last call for applications in Julyow for project fundingoin R&D enterprises, the project has received 20 million, with a total value of 25 million.

According to the director of the. development at OncoArendi Therapeutics S.A. Stanislaw Pikul, OATD-01 belongs to a completely new class of drugsow – so-called. inhibitoroin chitinases (mammalian acid chitinaseow and chitotriosidase). Chitinases are enzymes that digest chitin, a polymer found m.in. in the wall of the comorkowa fungusow.

The drug was selected for the clinical trial phase at the end of 2015. It was selected after testing ok. 1000 compoundsoin designed by the chemistoin company and tested by biologistoin zaroThis is the third time in Poland’s history that an innovative drug has entered the clinical trial phaseoith different types of biological models.

In an interview with PAP, the director of. of biology at the company, Dr. Karolina Dzwonek explained that more and more research indicates that chitinases are involved in the inflammatory process, but also in the process of włotissue tumors. Their mechanism of action is not fully known, but in patientoIn those with certain respiratory diseases, levels of active chitinases are significantly increased. Their number correlates directly proportional to the severity of the disease. – This indicates that they probably play an important role in the pathogenesis of these patients. Most data are related to the włolung disease and sarcoidosis, but roalso of asthma, hence our interest in these indications – said the specialist.

– We have already managed to show the therapeutic effect of OATD-01 in an animal model of asthma and a model of włolung disease,” she added.

Stanislaw Pikul stressed that the first phase of clinical trials of the drug will be conducted on healthy volunteers – manch. – The primary task of this study is to determine the safety of the drug, how it is tolerated, as well as its pharmacokinetics, or how it functions in the body, he explained. He added that the study will also help calibrate the therapeutic dose. As he pointed out, this week the drug will be given to the first man. According to him, this is a breakthrough moment, because until now no one has yet used an inhibitor of theoin chitinases in humans. – Administering this type of drug to humans involves a kind of uncertainty, because you don’t know what to expect – he explained.

Therefore, the study will be carried out at a specialized clinical center near Munich, Germany, ktory has experience with clinical trials of the type „First in Human”. Permission for it was granted by the German Product Registration Officeoin Medicinal and Deviceoin Medicine (BfArM).

To begin with, the company’s experts plan to test the therapeutic efficacy of the drug in asthma, but in the future roThe company’s task will be to drill a borehole in the idiopathic włopulmonary hemorrhage and sarcoidosis. They hope that drugs from the group of inhibitoroin chitinases will soon become an alternative to current therapies for these conditions.

The company’s goal is to bring the development of the drug to Phase IIa clinical trials and then sell the license to a global pharmaceutical company.

Deputy Minister of Development zwroShe pointed out that biotechnology is one of the project’soIn the strategic program of the current government – the Strategy for Responsible Development until 2020.

– In the pharmaceutical area, we have primarily generic drugs in Poland, which theore are very important, (. ) but on the other hand, we see that basing drug policy only on generic drugs is very krottotemporary perspective, hence such a strong emphasis on biotechnology – she explained.

She stressed that the dream „For Poland to become a biotechnology hub in Central Europe is not an exaggerated dream”. – We have human capital and a population thatora is extremely attractive for conducting clinical trials. And now the challenge facing the public administration is to change the legislation in such a mannerob so that these clinical trials can be conducted to a greater extent in Poland – mowiła. She added that work on legislative changes regarding this issue is already underway.