The information released by Molecure to the market around 2pm left investors frozen. Failure to obtain permission from the Polish Office for the Registration of Medicinal Products, Medical Devices and Biocidal Products to conduct a phase II clinical trial of the OATD-01 molecule resulted in more than 11%. Decrease in the share price of a listed company. The price then tried to rebound when the company issued a comment on the situation. Ultimately, the price fell by 4.15% at the end of the session. Up to PLN 18 per share. Turnover exceeded PLN 1.54 million on Tuesday.
The decision was surprising because in the current procedure, approval to conduct a phase II clinical trial of OATD-01 was given by ethical committees in Greece, Germany, France, Denmark, Norway and Poland itself. The National Office acted as rapporteur in the process of obtaining approval to conduct research in the European Union and Norway.
“The lack of approval by the regulatory office in the country acting as the arbitrator means that it is impossible to conduct a clinical trial in the European countries to which the application relates, even if other countries are likely to issue positive decisions,” the company wrote in the letter. press release.
As reported, one of the reasons for the refusal to issue authorization for a clinical trial, with regard to Poland, was the additional stringent requirement limiting the exposure of patients participating in the clinical trial to radiation, in particular PET/CT.
President Szumowski comments on this issue
“We are surprised and disappointed that although we made appropriate changes to the research protocol while evaluating the application and addressing the objections of the regulatory body, we received a scientifically unjustified attitude from the Polish Regulatory Office. Poland is the only country in the European Union with such a restrictive approach to diagnostics.” radiotherapy in clinical trials, which has been confirmed by radiologists from the world's leading clinical centers,” commented Marcin Szumowski, President of Molecure, in a press release.
“To our knowledge, the refusal was not due to safety issues related to the tested substance. We are ready to resubmit an application as soon as possible to conduct a Phase II clinical trial of OATD-01 in the territory of the European Union and Norway,” he added: “Except for medical centers and patients.” Poles due to legal restrictions related to diagnostic imaging (..) we will submit a new application, after choosing a new course, as soon as possible.”
Politics at WSE
Aside from the official announcement and reasons given, it is difficult to avoid speculation about a non-procedural reason for Molecure's disapproval. Politics immediately comes to mind. The head of Molecure is the brother of Łukasz Szymowski, Minister of Health in the government of Mateusz Morawiecki, as Puls Biznesu's Marcel Zatonski reminds us.
Moreover, Molecure was already in the sphere of attention of politicians in the Civic coalition immediately after its election victory, when MPs Junski and Shcherba conducted subsequent parliamentary inspections. They examined, among other things: the list of projects whose financing was approved just before the elections by the Polish Enterprise Development Agency, under which Molecure will receive PLN 32.5 million.
Molecure is a biotechnology company that uses its special competencies in medicinal chemistry and biology to research and develop drugs that could be a cure for many incurable diseases.
The most advanced drug candidate is OATD-01, which is subject to non-approval by the Polish office mentioned above. Research is being conducted on the treatment of, among others: sarcoidosis, a chronic autoimmune disease characterized by the presence of inflammatory masses called granulomas.
Molecure has already received approval to conduct phase 2 trials for OATD-01 in the USA and UK. Britain. There, trials on sarcoidosis patients will begin in the first quarter of 2024. The second candidate drug is OATD-02 for use in cancer treatment, as the first phase of its clinical trial began with the first patient dose in the first quarter of 2023.
Molecure debuted on the WSE in 2018 as OncoArendi Therapeutics. The company's largest investor is billionaire Michał Sołowow. He currently owns approximately 25 percent through his investment company MS Galleon. Involved. A package of approximately 7 percent. He also has President Marcin Szumowski and his company – Szumowski Investments sp.z oo
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