After winning the successful grant, Dr. Zsuzsanna Helyes, full professor at the Department of Pharmacology and Pharmacotherapy at the University of Pécs Medical School, has been able to continue the development of an innovative painkiller, which has been under research for nearly fifteen years in collaboration with pharmaceutical chemists from Budapest. During preclinical studies, the molecule was effective in several pain models, opening new perspectives for patients suffering from chronic neuropathic pain. Clinical trials are progressing in several phases, testing healthy volunteers is currently underway.
The compound „SZV-1287” combining many components was designed by Dr. Péter Mátyus, full professor at the Department of Organic Chemistry at Semmelweis University, then under the direction of Professor Zsuzsanna Helyes, colleagues of the chronic pain research group at the Department of Pharmacology and Pharmacotherapy at the University of Pécs Medical School, discovered and proved its effectiveness in numerous chronic neuropathic and inflammatory pain models.
They aim to develop a multi-target analgesic that is more effective and safer than the medicines which are currently available, since they are moderately or completely ineffective in treating chronic neuropathic pain and they also must be applied for long periods at high doses, often resulting in serious side effects.
Neuropathic pain affects a significant group of patients. Pain might originate from nerve damage caused by accidents or surgical procedures, sensory nerve injury related to diabetes or certain drug therapies, patients also experience this kind of pain who suffer from rheumatoid arthritis.
A successful GINOP grant made it possible to start the preclinical development and the human clinical trials (Phase I) of the „SZV-1287” compound, which became protected by two patents.
During the preclinical studies, researchers described the effectiveness, the safety, and the pharmacokinetic parameters of the molecule, and it was proved to be suitable for testing it in humans. Within the framework of the previous GINOP grant, the clinical phase regarding IA examinations were completed with healthy volunteers using four doses all at once, but in the project in 2025 two higher doses were used. This phase of the research was completed in December last year, and in order to continue with the clinical trial (Phase B), involving repeated dosing, permission was submitted earlier this year. Following the successful completion of Phase I, the next step is to demonstrate its effectiveness in patients suffering from chronic neuropathic pain, also involving potential industrial partners.
„Unfortunately, the coronavirus pandemic delayed our project, which resulted in a two-year setback. We were only able to begin the Phase IA human clinical trials in 2022 instead of 2020, which meant giving four doses all at once to healthy volunteers. The results indicated that the medicine had been safe, so the pharmaceutical authority recommended to test two additional, higher single doses in order to optimally plan Phase IB, which involves repeated dosing for ten days. We collaborated with Algonist GmbH, a company in Vienna, in 2023 and 2024 to implement this, we were searching for grant and investment but were unsuccessful then. We received support from the Ministry and the National Research, Development, and Innovation Office in 2025, so we were able to proceed with the project, and this year we also have the opportunity to continue the repeated-dose testing. We proceed with the development according to our plans recently, and the results clearly show that the medicine is absorbed from the capsule in the intestinal tract and does not cause any significant side effects.” – Dr. Zsuzsanna Helyes commented on the progress of the project.
She said that the funding from the government would be enough to conduct the examination using three doses over a ten-day period in healthy volunteers in 2026, and If the compound continues to be safe, the Phase IIA could begin in 2027 to prove its effectiveness in several hundred patients suffering from chronic neuropathic pain. This phase will require greater financial resources, so involving industrial partner will be necessary. Apart from Algonist GmbH, the research team is looking for investors or other industrial partners. The research team is currently negotiating with potential European, Korean, and Chinese partners, as funding for testing patients is not available yet. Since the value of the project increases exponentially after completing Phase I successfully, they also discuss possible joint development, licensing agreements, or the acquisition of the patent with major pharmaceutical companies.
„Regarding registration and placing it on the market, its efficacy, safety, and its behaviour in the human body must be demonstrated and proved in several thousand patients, and that procedure costs billions. So, involving major pharmaceutical company is required, as researchers at universities and small companies are not capable of supporting this alone. Because of these reasons, even under the most ideal circumstances, we cannot realistically expect that the medicine enters market before 2029–2030.” – she added.
She emphasized that more than a hundred people had been working on the project so far. During the preclinical studies, several chemists, pharmacists, biologists, and medical researchers from the University of Pécs and Semmelweis University carried out the synthesis of the active substance, the formulation and characterization of the capsules absorbing in the intestinal tract, as well as the experimental testing of the capsules in cell cultures and animal models, and the analytical studies in collaboration with Toxicoop Ltd. In the clinical trials, DRC – Drug Research Center leads the work in Balatonfüred, Toxicoop handles the analytics, and Pharmaregist manages the administrative tasks regarding registration.
The Phase IA with the two additional doses was conducted under the grant „2025-3.1.1-ED-2025-00022 Clinical Development of the SZV-1287 Drug Candidate”, with a budget of 100 000 000 forints.
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