STOCKHOLM, March 7, 2019. Karolinska Development's portfolio company Forendo Pharma today announces positive results from a Phase Ia study with the drug candidate FOR 6219 for the treatment of endometriosis. The results found FOR 6219 to be safe and well tolerated, with good pharmacokinetics at the doses tested.
The randomized, double blind, placebo controlled Phase Ia study investigated the safety, tolerability, food effect and pharmacokinetics of single and multiple ascending oral doses of FOR 6219 in 36 healthy postmenopausal women.
In the study, single doses of FOR 6219 from 2 mg up to 175 mg and multiple doses up to 150 mg twice daily for ten days were found to be safe and well tolerated. The pharmacokinetic results showed a dose proportionate exposure and no significant food effect.
The safety and pharmacokinetic profile of FOR 6219 supports the initiation of a Phase Ib clinical trial in healthy premenopausal women with the aim to demonstrate Proof of Mechanism. The selective ability of FOR 6219 to inhibit local estrogen production in the endometrium and endometriotic lesions without suppressing women's systemic estrogen levels is expected to be a key differentiator against competing endometriosis therapies. The Phase Ib study is planned to be initiated in the summer of 2019.
"The positive results from the Phase Ia study of FOR 6219 is an important milestone for Forendo Pharma. As the next step in the development of a potential first in class drug for the treatment of endometriosis we will now start the preparations for a Phase Ib study", said Viktor Drvota, CEO of Karolinska Development.
Endometriosis is a chronic condition that affects up to 10 per cent of women in reproductive age and causes repeated pain symptoms, infertility and impaired quality of life. Currently available treatments for endometriosis have limitations in efficacy or cause harmful side effects, due to estrogen depletion.
For further information, please contact:
Viktor Drvota, CEO, Karolinska Development AB
Phone: +46 73 982 52 02, e-mail: viktor.drvota@karolinskadevelopment.com
TO THE EDITORS
About Karolinska Development AB
Karolinska Development AB (Nasdaq Stockholm: KDEV) is a Nordic life sciences investment company. The company focuses on identifying breakthrough medical innovations in the Nordic region that are developed by entrepreneurs and leadership teams. The Company invests in the creation and growth of companies that advance these assets into commercial products that are designed to make a difference to patients' lives while providing an attractive return on investment to shareholders.
Karolinska Development has access to world-class medical innovations at the Karolinska Institutet and other leading universities and research institutes in the Nordic region. The Company aims to build companies around scientists who are leaders in their fields, supported by experienced management teams and advisers, and co-funded by specialist international investors, to provide the greatest chance of success.
Karolinska Development has established a portfolio of ten companies targeting opportunities in innovative treatment for life-threatening or serious debilitating diseases.
The Company is led by an entrepreneurial team of investment professionals with a proven track record as company builders and with access to a strong global network.
For more information, please visit www.karolinskadevelopment.com
