Pikralida announces successful completion of Scientific Advice discussion with the Finnish Medicines Agency Fimea for PKL-021. Agreement on Phase 1 clinical trial design.
Poznan, Poland, March 27, 2023 – Pikralida sp. z o.o., biopharmaceutical company developing breakthrough therapeutic solutions to address unmet medical needs of patients, today announced that it has successfully concluded its scientific advice discussions with the Finnish Medicines Agency Fimea on the Phase 1 clinical trial design for PKL-021.
Pikralida is developing PKL-021, a low-molecular-weight matrix metalloproteinase inhibitor, as an innovative therapeutic solution protecting against the development of the post-traumatic and post-stroke epilepsy. The clinical candidate PKL-021 was selected by applying repurposing strategy and is an abandoned Phase III drug candidate. Pikralida sought the advice of the Agency on the scope, assumptions, and results of nonclinical studies, that had been planned to substantiate the use of PKL-021 in phase 1 clinical trial.
“We spent intensive, but exciting time working on chemical process and drug formulation development, and executing comprehensive nonclinical plan of pharmacology, pharmacokinetic and toxicology studies. We feel confident receiving Agency confirmation that the overall nonclinical program is adequate and preclinical safety program is sufficient to proceed to phase I clinical study”. – says Anna Krause, Ph.D., Head of R&D.
Pikralida reached agreement with the Fimea on all the key elements of the planned Phase 1 clinical trial. The Agency agreed with a general design of the proposed clinical study composed of Part 1 involving administration of a single dose of the investigational medicinal product (IMP) under fasting and fed conditions, followed by Part 2 during which participants will receive multiple dose of IMP.
“We are very pleased with the positive outcome of our discussions with the Fimea. The phase 1 clinical trial for PKL-021 is designed in optimal way, and after its completion, we will be able to proceed with clinical studies in patients.” – commented Stanislaw Pikul, Ph.D., President of Pikralida.
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 traumatic brain injury or 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.
Pikralida is developing PKL-021, a low-molecular-weight matrix metalloproteinase inhibitor, as an innovative therapeutic solution protecting against the development of the post-traumatic and post-stroke epilepsy. PKL-021 has high activity and optimal drug-like properties. Its postulated therapeutic effect was demonstrated in in vivo studies. The drug substance was manufactured, the in-life phases of preclinical studies are complete, and the manufacturing campaign of the investigational medicinal product is being initiated. Pikralida intends to submit the Clinical Trial Application mid-year in 2023 and to initiate the phase 1 clinical trial by the end of the year.
The project carried out by the consortium of Pikralida sp. z o.o. and the Nencki Institute of Experimental Biology of the Polish Academy of Sciences, entitled “Use of matrix metalloproteinase inhibitor for the development of an innovative therapeutic method for preventing the development of post-injury and post-stroke epilepsy” is co-funded by the European Union under the Operational Programme Smart Growth 2014-2020.
For Additional information about Pikralida visit www.pikralida.eu