Evestra Onkologia Sp. z o.o. Announced Today Initiation of First-in-Human Phase I Clinical Studies Targeting Endometriosis, Uterine Fibroids and other Gynaecological Disorders
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.