ChemRar and Pharmasyntez have signed a license agreement for the development of an innovative anti-flu drug

14.04.2023

The ChemRar Group of Companies and Pharmasyntez, JSC have signed a license agreement on cooperation in the development and market launch of an innovative drug against novel influenza viruses. The candidate drug, developed by scientists of the ChemRar Group of Companies, has demonstrated high efficacy and safety in preclinical studies.

In the in vitro studies, the molecule showed high potency at nanomolar concentrations against a panel of influenza A and B viruses in multiple inhibition assays. The investigational candidate belongs to the class of CYP-dependent influenza virus endonuclease inhibitors that are well characterized in terms of safety and have a similar route of administration and dosing regimen to the marketed drug baloxavir marboxil (Xofluza).

A distinctive feature of the ChemRar Group of Companies' development is the convenience of administration. The drug is being developed as a single dose for the treatment of acute uncomplicated influenza in adults, including resistant forms.

The first clinical trials to assess the safety and tolerability of the investigational drug are planned for the end of the second quarter of 2023. Further research will be carried out jointly with the Pharmasyntez company team.

This is not the first experience of the partners in the development and market launch of innovative domestic medicinal products. In 2016, the ChemRar Group of Companies registered an innovative antihyperglycemic drug Saterex® (INN — Gosogliptin) – the first Russian single-dose gliptin for monotherapy and treatment in combination with metformin of diabetes mellitus type II. A large research program for the drug was launched in 2012 after obtaining an exclusive worldwide (excluding China) license from Pfizer to develop, manufacture, register and commercialize the drug. The clinical trials proved the safety and efficacy of Saterex® as monotherapy and in combination with metformin in comparison with Vildagliptin in appropriate regimens. In 2018, the rights to the drug were transferred to the company Pharmasyntez, which continued development of the project and registered the medicinal product in Uzbekistan and Kyrgyzstan in 2020.

“There is every reason to believe that our specialists will become leaders in the fight against resistant strains of influenza through joint efforts, taking into account the previous successful experience of working with the Pharmasyntez team, as well as the expertise and unique capabilities of the ChemRar Group of Companies in drug development, which in 2020, at the very beginning of the pandemic, made it possible to create and market in a short time the world's first drug against COVID-19 Avifavir,” said Elena Yakubova, Project Manager and CEO of ChemRar Pharma.

“Despite the wide variety of drugs aimed at the treatment of acute respiratory viral infections, including influenza, the development of new drugs with advantages in terms of efficacy and convenience of administration remains an important challenge for the pharmaceutical industry. Based on the scientific data obtained by the ChemRar Group of Companies during the development of the innovative drug, we hope for the success of the upcoming clinical trials, which will eventually allow our compatriots to treat the flu with just one tablet," said Roman Ivanov, Director of Innovation Development at Pharmasyntez, JSC.