The objective of the project is to confirm the therapeutic action of the PI3K inhibitor in patients with lung diseases such as asthma or chronic obstructive pulmonary disease (COPD). The planned route of administration of the drug is inhalation. The project involves actions taken in four stages, including preclinical and toxicological studies, drug formulation, as well as phase I and II clinical trials.
Jerzy Pieczykolan, PhD, Head of the Preclinical Research Department in Celon Pharma S.A: Analyses indicate that 5-10% of people suffering from asthma do not respond to available drugs. It is therefore reasonable to search for new therapeutic options which would be safe for long-term use, to replace the currently used steroids or reduce their doses. The PI3K inhibitor developed by Celon Pharma S.A. constitutes a promising alternative for the treatment of steroid-resistant asthma and COPD; it has a very favourable safety profile for the patients.
Maciej Wieczorek, PhD, CEO of Celon Pharma S.A.: We continue investing in the development of our competence in the field of inhalation therapies. In this case, administration of the drug directly into the lungs will help minimise adverse effects resulting from the systemic action of PI3K inhibitors.
The project was launched in December 2015 and is planned to be finalised in June 2020, which is when phase IIa (proof-of-concept) clinical trials will be conducted.
The total value of the PIKCel project is PLN 23,508,985.88, of which PLN 15,373,271.42 will be received by the company under the Smart Growth Operational Programme.