Polish company wants to enter the American market. It's about diabetes therapy

PolTREG has established an American company, Immuthera , which has been registered in the state of Delaware. This is to enable a more effective entry into the US market, and the first actions will be preparations to start the registration process and a plan to create a scientific council.

PolTREG will talk to experts from the FDA

The plan is to submit a pre-registration application, or pre-IND, to the US Food and Drug Administration (FDA). The meeting and initial talks with experts from the agency will allow for a discussion of plans for clinical trials and registration of the therapy.

-Thanks to pre-IND, we can obtain valuable advice from the FDA to avoid procedural errors and speed up the process of introducing the therapy to the US market. The pre-IND meeting is particularly important because it often allows for early detection and resolution of potential problems related to clinical trials, which increases the chances of success of the entire development process - said Piotr Trzonkowski, president of PolTREG, quoted in the press release.

Immuthera is also in the process of establishing a Scientific Advisory Board composed of experts in the field of diabetes-related and autoimmune diseases.

The Council is to play an important role by providing an independent , expert assessment of research projects and, in the company's opinion, will provide strategic substantive and image-related support necessary for further development and acquiring partners on the international stage.

Getting experts to join the scientific council will be a difficult task

As Piotr Trzonkowski adds - Therapies such as polyclonal Treg lymphocytes, CAR-TREG, allogeneic therapies, antigen-specific Treg and mRNA immunotherapies have been arousing interest among international experts for years. Although the path from interest or rooting for us to the actual involvement of top names in supporting PolTREG is not easy -.

The company's main shareholders are PAAN Capital (21.31% of shares and 19.29% of votes), Venture FIZ (18.97% of shares and 17.18% of votes). Minority stakes are held by the company's founders and researchers: Natalia Marek-Trzonkowska, Piotr Trzonkowski and Małgorzata Mysliwiec.

PolTREG has been listed on the main floor of the Warsaw Stock Exchange since November 2021.