News

Evestra Onkologia Sp. z o.o. (www.evestraonkologia.pl) announced today initiating of first-in-human (FIH) Phase I clinical studies to assess pharmacokinetics and safety/tolerability of EVE126 (EC313), a novel agonist/antagonist candidate that targets endometriosis, uterine fibroids and other gynaecological indications.

This important  milestone highlights  the company’s dedication to advancing women’s health R&D and quality-of-life through groundbreaking research and development.

EVE126 (EC313) is a new chemical entity (NCE) steroidal small molecule developed via medicinal chemistry structure activity correlation as a third generation SPRM to treat a wide range of women’s health disorders. While first and second generation SPRMs are either pure PR-antagonists or possess very high antagonistic activity, EC313 was designed to possess both PR-antagonistic as well as PR-agonistic activity.

These Phase 1 studies are first, randomized, single-blind, placebo-controlled, single- ascending Dose, and second, multiple dose study evaluating the safety, tolerability, and pharmacokinetics of  oral EC313 in healthy postmenopausal women is divided into two parts.. These Phase I studies  will generate the necessary data necessary to enter Phase II studies and beyond.

Following intensive EC313 drug development efforts in the last few years,  it is especially gratifying to our entire team to enter the clinical phase.  It is a reflection of the company’s “can do” mentality and culture says Evestra Onkologia managing director, Maciej Wierzbicki, PhD

The development of EC313 including the clinical trial conducted by Evestra Onkologia Sp. z o.o. is co-funded by the National Centre for Research and Development (agreement POIR.01.01.01-00-0123/16).

Evestra Onkologia Sp. z o.o. is a Polish biopharmaceutical start-up company located in Łódź,   and established as a wholly-owned subsidiary of Evestra, Inc., a biopharmaceutical company headquartered in San Antonio, Texas, USA.

Lodz, 05.09.2023 – Evestra Onkologia is pleased and honoured to announce the publication of its latest scientific article in the renowned endocrinology journal Frontiers in Endocrinology (IF=5.2/2022). The article titled ” Next Step in the Development of Mesoprogestins: The Preclinical Profile of EC313” by Katarzyna Blaszczak-Swiątkiewicz et al. was published in the second most cited endocrinology journal.

The article describes the preclinical part of the development program of a mesoprogestins drug candidate that is the only one in its class. The paper presents the results of the numerous in vitro and in vivo studies conducted, including pharmacodynamics.

The publication in one of the most cited endocrinology journals underscores the importance of scientific achievements in the pursuit of further development of EC313 with an indication for the treatment of endocrine malignancies underlying the development of endometriosis.

Interested parties can read the full article on the journal’s website or visit our website to learn more about our research and commitment to endometriosis treatment.

Evestra Onkologia in line with its strategic objectives entered into a collaboration agreement with the Medical University of Łódź. The objective of this collaboration is to take advantage of the respective competencies of both organizations in the field of biotechnology and pharmaceutical research to enhance innovation in Poland., This collaboration will also generate favorable conditions for public/private cooperation. Areas of collaboration are development of innovative medicines and therapies for use in the treatment of endocrine diseases, estrogen-dependent tumors, and in addition, training of professionals in modern biotechnology and pharmaceutical research.

Evestra Onkologia Sp., has received a major research and development grant. The $4.6 million project, co-financed by the European Union Regional Development Fund, will support development of a drug – EC313 – designed to treat endometriosis.