The project of the Pikralida and Nencki Institute of Experimental Biology in Warsaw, was chosen by the National Centre for Research and Development within 3/1.1.1/2020 Fast Track for Mazovia competition. The total cost of the project was estimated as approximately 21.6 million PLN, and the recommended funding amount was defined as 16,9 million PLN.
The development of epilepsy is a common complication after a traumatic brain injury or a stroke. Based on the current estimations, 2.3 million serious head injuries and up to 1.9 million strokes occur annually in Europe and the United States. Each of these events can initiate epileptogenesis leading, in the consequence, to the development of epilepsy.
The aim of POIR.01.01.01-00-0235-20 Project is to develop a breakthrough therapeutic solution protecting against the development of post-traumatic and post-stroke epilepsy based on the inhibition of the epileptogenesis process through the modulation of the enzymatic protein, matrix metalloprotease 9 (MMP-9). MMP-9 inhibitor named PKL-021 selected within the project is a low molecular weight chemical compound with high activity and optimal drug-like properties. The project covers, among others, development of the active substance and investigational medicinal product manufacturing technology, analysis of the therapeutic potential of the MMP-9 inhibitor in the animal models, and carrying out the preclinical and phase I clinical studies.
- Project budget: 21,564,812.50 PLN.
- Co-financing of the project from the European Funds: 16,919,633.00 PLN.
– I believe that the clinical studies will confirm the therapeutic potential of the PKL-021 molecule, the inhibitor of the matrix metalloprotease 9, in the inhibition of the post-traumatic and post-stroke epilepsy development. We are pleased to develop such an innovative drug together with the Pikralida specialists. – says professor Leszek Kaczmarek, Head of the Laboratory of Neurobiology in Nencki Institute of Experimental Biology.
– We are very proud that the project of Pikralida and the Institute of Experimental Biology has been appreciated by the experts of the National Centre for Research and Development. Thanks to the obtained financing, we will intensify the research and development on the innovative therapy based on the studies of professor Leszek Kaczmarek . We plan to initiate the proof-of-concept phase II clinical trials with patients in 2024. – says Stanisław Pikul, President of the Board in Pikralida sp. z o.o.
Epilepsy is a chronic neurological disease with recurrent epileptic seizures, which are an expression of transient brain dysfunction resulting from excessive, sudden, and spontaneous bioelectrical discharges in nerve cells. Currently, for about 30% of epilepsy cases there is no cure available and constant pharmacotherapy is required to relieve the symptoms. The manifestation of epileptic seizures and the constant use of medications cause significant limitations in the professional and social life of affected individuals. The development of epilepsy is a common complication after a traumatic brain injury or a stroke. No drugs inhibiting epilepsy development have been developed so far.
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