Posts in category: News

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.

About PKL-021

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

On 15 and 16 November, we will participate in the Deep Tech Summit, which will be held in the Cambridge Innovation Center in Warsaw.

The intention behind the event is to connect and educate:

• private investors seeking unique projects,
• start-up founders in need of new team skills and funding,
• managers and project managers open to new business challenges,
• researchers interested in launching and developing R&D-focused companies,
• entrepreneurs looking for new business projects
• as well as international partners willing to work with the Polish Deep Tech ecosystem.

The programme for the event is available at: Programme

We are very proud to announce that Pikralida has been included in the Deeptech Map in the Central European region. Technologies dubbed “deep tech” are defined as breakthrough solutions based on technological achievements that are unique, protected and difficult to replicate.

Initially, the term referred only to research and development divisions of large corporations in the defence or telecommunications sectors. However, in recent years its meaning augmented to encompass start-ups as well. Deep tech start-ups have the chance to create solutions that are unconventional and solve real problems. However, both the innovative nature of the solutions and the need for research and design mean that it takes a really long time to bring a new project to market very long. Thus, this type of start-up bears increased technological risk at the stage of research and development (i.e. solution creation). Hence, deep tech solutions are characterised by large capital needs. Investors are sought who are ready to make an investment associated with technological risk. A map of the Central European deep tech ecosystem is therefore a valuable database for such investment firms.

Poland currently has approximately 150 deep tech start-ups

• 30 chemical start-ups
• 42 med tech deep techs

Interestingly, in terms of investment, 2022 is a record year, with EUR 299 million (PLN 1.39bn) invested in regional deep tech, more than in the whole of 2020.

And as soon as in November, together with Aper Ventures and Innovative Poland (Slawomir Olejnik) we will meet for the first time at Deep Tech Summit.

Here is the link to Central Europe Deeptech Startup Map

#deeptech #cee #vc

Our Scientists: Hanna Kierońska, Katarzyna Rogut and Michał Kretkiewicz took part in the international scientific conference ‘New trends in Polish and global pharmacy: science, business and modern education’, held in Poznań on 29-30 September 2022.

It was an excellent opportunity to share the newest news on our projects involving innovative drug product formulations and delivery systems during informal meetings. Conference participants included representatives of the scientific pharmacy community from Poland, Germany, the Czech Republic, Lithuania, Ukraine and the US.

Here is the link to the conference programme

Joanna Lipner represented Pikralida at THURSDAY GATHERING, taking part in the debate and presenting the company during the pitching session.

The topic of the debate, chaired by Izabela Kozakiewicz-Frańczak, was: “Industries of tomorrow: Medicine”. Participants in the debate focused on questions such as:

• What are the predominant trends in medicine today?
• Which are common on the needs side, and which prevail on the supply/development side of innovation?
• What are the characteristics of development of the medical sector?
• What innovations emerge in the most advanced countries, and what is the situation in CEE and Poland?
• What are the biggest challenges when it comes to the creation of Polish innovation and is Poland globally competitive?

THURSDAY GATHERING meetings are organised by Venture Cafe Warsaw Foundation. Participants include representatives of start-ups, investors and those interested in innovation. It is an opportunity to broaden both your mind and network.

This year’s #118 LIFE SCIENCE SESSION was organised at CIC Warsaw on 29 September 2022.

Link to the pitching session recording – presentation by Pikralida
Link to the material from the debate

Pikralida sp. z o.o. is one of the winners of the “Rzeczpospolita” Innovation Eagle awards in the category Start-up with potential Poland – Global

Our start-up received an award for work dedicated to the discovery and development of small-molecule chemical compounds with therapeutic potential to be used in central nervous system diseases. We have thus joined the ranks of the authors of projects that could be considered a showcase for Polish innovation. The ‘good chemistry’ that fosters our company’s development in the biotechnology sector, as well as all the Winners of this year’s Innovation Eagle edition are described in “Rzeczpospolita”.

We would like to thank the Jury: Maciej Maciejowski, Jarosław Sroka, Marcin Szczeciński, Paweł Grzegorczyk, Darek Żuk and Marcin Piasecki for having seen the potential of our company and our R&D projects.
Now, the company’s growth would not have been possible if it weren’t for the amazing Pikralida team. Thank you!

An innovative project implemented by Pikralida: “Use of matrix metalloproteinase inhibitor for the development of an innovative therapeutic method for preventing the development of post-injury and post-stroke epilepsy” has been included in the healthcare innovation map created by the Ministry of Health’s Innovation Department.

The innovation map presents innovative projects, ventures, services and products that are designed to improve the functioning of the health care system in Poland. The intention behind the initiative is to make sure that the patient receives the best possible care, that appropriate support is provided to medical staff, and that the efficiency, quality and accessibility of the services provided is enhanced.

The main objective of the map is to bring together innovative healthcare projects in a single space, while providing the option of a readily searchable database of projects of interest by selected categories and specialisations. This makes it easy to sort through projects both by specialists, who can find solutions in their speciality here, and by patients, who may seek medical innovations to meet their health needs. The map is equally useful to private and public entities that want to collaborate in a particular area of innovation with other entities that have experience in a particular category or specialisation.

Here you can find the Innovation map of the Ministry of Health

Joanna Lipner represented Pikralida sp. zo.o. in a panel discussion at Big Pharma Day2022, an event organised this year by the CITTRU Technology Transfer Centre at the Jagiellonian University.

Knowledge exchange and experience sharing is crucial to encouraging collaboration and creating successful partnerships between academia and industry.
The event gathered experts, both former and current employees of major Polish and foreign pharmaceutical companies with experience in the development and commercialisation of novel therapeutic molecules, as well as managers investing in and supervising biomedical companies.
The two-day meeting focused on drug project planning, drug substance development, the needs of the pharmaceutical industry and obtaining research funding from business partners and public agencies.

BigPharma Day2022 in a nutshell:

• there’s a lot of interesting things happening at Polish universities (there will be a synchrotron in Poland! @Solaris)
• pharmaceutical companies are looking for projects and are open to talks, but they expect the project to be presented in a synthetic form with a specific background – detailed project documentation is key;
• companies are open to collaboration with academic groups which have developed interesting disease models or which are able to conduct advanced research into molecular mechanisms;
• despite several undisputed successes of Polish biotechnology companies, Polish VC funds are still very cautious (if not openly sceptical) when it comes to investing in young biotech companies developing new drugs,
• #EuropeanFunds allowed the rapid and dynamic development of Polish biotechnology companies. It is to be hoped that more calls will follow soon!

Here you can find event announcement and BigPharma Day agenda
#drugdiscovery

#drugdevelopment

#newdrugs

#collaboration

Anna Krause and Stanisław Pikul represented Pikralida at the 7th Scientific and Training Conference of the Polish Neurological Society held on 14-17 September in Lublin.

A poster presenting the results of the in vivo research conducted as part of the EpiFix project was presented at the conference: “Use of matrix metalloproteinase inhibitor to develop an innovative therapy of preventing the development of post-injury and post-stroke epilepsy.”
This year’s convention was held in a stationary format, which allowed participants to attend multiple meetings during four days filled with plenary, workshop and special sessions. There were opportunities to talk and share knowledge with clinicians and experts in the field of neurology.

Conference information page

Pikralida has been invited to have its say in Science|Busines magazine on the topic of the challenges and issues faced in Poland by companies dealing in innovative drug development.

Polish biotechnology is seeking a solid foundation for future growth Generous EU funding mean that medical biotechnology start-ups are thriving in Poland, but tapping the huge potential held by the sector is impeded or held back by many deep-rooted hindrances. One of the biggest challenges is the reorganisation of the public funding management system. As it turns out in practice, this also affects the possibility of obtaining grants from private sources, which are necessary to cover 20 to 40 per cent of the cost of projects. With little own expertise that would allow them to form an opinion on a biotech company, private funds effectively rely on public grant-making agencies. “Private funds or investors will look at the size of the grant and use it to value our companies” – said Stanisław Pikul, CEO of Pikralida.

An important factor contributing to the development of biotechnology is the cooperation of biotech with the academic milieu. One of the advantages of the Polish landscape is that – owing to EU funding – university laboratories are now excellently equipped. “It is now possible to perform almost any high-quality chemical testing quickly and efficiently at the university, which was only a dream ten years ago”, as seen by Joanna Lipner, managing director of Pikralida. “The level of understanding of drug discovery and development processes across the academia has indeed improved, but it is changing at a snail’s pace.” Problematic issues here range from a general lack of understanding that bright concepts should be commercialised, to practical problems associated with documentation and study designs that lack the results required to transfer research from the laboratory to the clinic.

Another important aspect for the future growth of Polish biotechnology companies is to have access to experienced specialists and experts as well as the possibility of acquiring sufficient space to develop companies and build laboratories. And this is still a big challenge for technology start-ups in Poland.
Here you can find: Pełną treść artykułu