Posts in category: News

Pikralida sp. z o.o. entered cooperation with Polpharma S.A. the leader of the Polish pharmaceutical market, offering to its worldwide partners process development and contract manufacturing services for active substances and drug products.

The cooperation involves manufacturing of the drug substance of the clinical candidate PKL-021, needed to support the preclinical research program and the production of an investigational medicinal product for the phase one clinical trial. The manufacturing process will be conducted by Polpharma, in accordance with the Good Manufacturing Practice (GMP) standards.

In cooperation with the M. Nencki Institute of Experimental Biology, Pikralida is working on a breakthrough therapy that protects against the development of epilepsy after a brain injury or stroke. The project is based on the results of years-long research on the role of MMP-9 enzyme in the development of the epileptogenesis process. The research has been conducted under the supervision of prof. Leszek Kaczmarek, head of the Laboratory of Neurobiology of the Institute of Experimental Biology M. Nencki PAN.

We are working intensively on the preparation of our clinical candidate PKL-021 for the Phase I clinical trial. One of the extremely important elements of the project, at the same time limiting its progress, is the availability of the drug substance. The Pikralida Process Chemistry team has developed an efficient synthesis process for PKL-021. We have decided to entrust the manufacturing of the drug substance according to the cGMP standard to Polpharma S.A., which has a team of qualified specialists with extensive experience in the production of active substances in the GMP standard. We are convinced that our project is in the hands of the best specialists in the country, and that the tested substance will meet the stringent standards set by the European regulatory authorities – says Dr. Stanisław Pikul, President at Pikralida sp. z o.o.

Thanks to the extensive experience of our API team in the development of chemical processes and their scaling and production under cGMP conditions, we are supporting our customers and partners, innovative companies, at every stage of the development of drug candidates, from API supplies for preclinical studies to validation, commercial launch, and full life cycle management. We are glad that we will cooperate with a group of specialists from Pikralida who have developed a technology that we will be able to transfer to Polpharma in order to produce the active substance for the project. Using the best knowledge and competence of our specialists in active substances and our state-of-the-art facilities, we will provide Pikralida with a seamless platform to support their clinical trial program, which we all hope will finally result in breakthrough therapy to prevent the development of epilepsy. – says Sebastian Szymanek, President of the Management Board of Zakłady Farmaceutyczne Polpharma S.A.

Pikralida sp. z o.o. is a biopharmaceutical start-up developing a portfolio of R&D projects involving therapeutic solutions based on innovative small-molecule substances, innovative formulations of combination drugs, and state-of-the-art drug delivery systems.

Zakłady Farmaceutyczne Polpharma S.A. is a leader of the Polish pharmaceutical market and one of the leading drug manufacturers in the region of Central and Eastern Europe. Currently, the company is part of a strong international pharmaceutical group, offering modern drugs, substances and innovative solutions for patients and business partners from around the world. The company’s mission is to help people live a healthy life in a healthy world. Polpharma CDMO offers development and contract manufacturing services for active substances and ready-made drugs to partners from all over the world.

The project POIR.01.01.01-00-0235/20-00/of the Pikralida and Nencki Institute of Experimental Biology in Warsaw named Utilization of a matrix metalloprotease inhibitor to develop an innovative therapeutic method that prevents the development of post-traumatic and post-stroke epilepsy is implemented under the Smart Growth Operational Program 2014 – 2020..

Pikralida sp. Pikralida sp. z o.o. was presented in the latest report “Top Disruptors in Healthcare 2022”.

This year, the Report includes 144 Polish startups, as well as 14 from the CEE region! The report contains in-depth statistical research conducted with regard to Polish startups.

The document is available on the website of the Polish Hospital Federation and at the link: https://lnkd.in/eZjwc3Yy

As part of the Reach4.biz Meetup conference, we had the pleasure to present our team and R&D projects during a presentation panel of 10 startups founded by women. The panel was sponsored by Sieć Przedsiębiorczych Kobiet .

During the Reach4.biz Meetup conference, we had the opportunity to listen to many interesting debates and pitches by other young companies, as well as talk to representatives of VC funds.

Pikralida team attended the Interdisciplinary Conference on Drug Sciences Konferencji Nauk o Leku ACCORD 2022. The goal of the event was to integrate scientific and industrial activities that focus on different aspects of drug research.

During the conference we presented two scientific posters. The poster titled “ A breakthrough therapeutics solution protecting against the development of the post-traumatic and post-stroke epilepsy “ was selected by the Organizers to the Poster Spotlight Presentation.

Pikralida wins an award at CEBioForum.

We are excited to let you know that during the 20th edition of CEBioForum2022 Pikralida sp. Pikralida sp. z o.o. and Nencki Institute of Experimental Biology PAS received the award in the category R&D Collaboration for the joint project EpiFix. The aim of the project is to develop a breakthrough therapeutic solution protecting patients against the development of post-traumatic and post-stroke epilepsy. Projekt EpiFix /POIR.01.01.01-00-0235/20-00/jest współfinansowany is co-financed by the European Union under the Smart Growth Operational Program..

Związek Firm Biotechnologicznych BioForum  stworzył wspaniałą mapę prezentującą polski ekosystem biotechnologiczny. Jesteśmy dumni, że jesteśmy jego częścią!

A drug may soon provide protection for patients with epilepsy that may develop as a complication of brain injury or stroke. We interview dr Stanisław Pikul, CEO of Pikralida, to learn about the potential this innovative therapy will offer patients as well as the key points of new drug development

Pikralida is a biopharmaceutical start-up that develops medicinal products. You discover and develop breakthrough therapeutic solutions. What’s the secret of your strength?

STANISŁAW PIKUL: The dynamic growth and successes of the company would not be possible if it weren’t for the very deliberately selected team of professionals who combine knowledge and experience with a dauntless spirit that enables them to bravely face new challenges and seek groundbreaking solutions. We are driven by passion, we aim high, and we welcome new quests. The building blocks of our projects include smooth collaboration, expertise and shared commitment.

Currently, your major project is EpiFix, aiming at the development of a novel drug. Could you tell me a bit more about it?

With Epifix, our core, most advanced project, we intend to come up with a breakthrough therapy to protect patients from developing post-traumatic and post-stroke epilepsy. Our work is based on the results of many years of scientific research conducted by Professor Leszek Kaczmarek, head of the Neurobiology Laboratory at the Nencki Institute of Experimental Biology of the Polish Academy of Sciences, which have shown that following a severe head injury or stroke, there is a short-term increase in the activity of an enzymatic protein, matrix metalloproteinase 9 (MMP-9) in the proximity of the injury, which may initiate epileptogenesis. The therapy under development is to block this process by modulating the activity of the MMP-9 enzyme. Research identified a drug candidate, an MMP-9 inhibitor called PKL-021, a low molecular weight chemical compound with high activity and optimal drug like properties. The presumed therapeutic effect of the PKL-021 inhibitor was confirmed by extensive in vivo studies.

How much longer is the research going to take?

It usually takes several years to develop a novel drug. The cycle comprises several characteristic steps, with the first being the discovery phase, i.e. the stage from conceiving a drug to selecting a drug candidate from hundreds of compounds. The preclinical development stage, which starts when the drug candidate is identified, encompasses a wide spectrum of advanced research work carried out as a preparation for Phase I clinical trial, when the experimental drug is first administered to human subjects. The next stage consists in clinical trials designed to evaluate the safety of the drug and to investigate in depth its therapeutic potential. We are currently involved in intensive work with the intention to prepare a clinical candidate, compound PKL-021, for a Phase I trial, which we intend to conduct in 2023. If we obtain positive results from the Phase II clinical trial, the new drug may well enter the market within 5 to 7 years.

What are your other achievements?

Our greatest success is that we brought together a tight-knit team of over 20 people, all looking forward to taking on new challenges. We are glad that we have the opportunity to work with academic institutions and pharmaceutical companies, a cooperation that gave rise to four projects co-financed by Polish and European funds.

The project entitled “Use of matrix metalloproteinase inhibitor to develop an innovative therapy of preventing the development of post-traumatic and post-stroke epilepsy” /POIR.01.01.01-00-0235/20-00/ is co-financed by European Funds under the Smart Growth Operational Programme 2014-2020.

Not only we conduct our own research projects; we also provide specialist R&D services. We heartily welcome the positive feedback from our Clients – the best evidence of our expertise and competence.

Stanisław Pikul

Original interview with the President of Pikralida, Stanisław Pikul, in Forbes magazine:

On the 21st of February 2022 we are celebrating the 3-rd anniversary of Pikralida sp. z o.o.

We had the pleasure to present our modern R&D laboratory in Poznań in the program We’re Changing Greater Poland.