Stockholm (GLOBE NEWSWIRE) - Karolinska Development's portfolio company Forendo Pharma today announces that it has received clinical trial authorization (CTA) from the Medicines and Healthcare products Regulatory Agency (MHRA) in UK to commence a study for its lead program FOR-6219.
The phase Ia trial is a randomized, double-blind, placebo-controlled study in healthy postmenopausal women aged between 45 and 65 years. The primary objectives of the study will be to investigate the safety tolerability and pharmacokinetics of single and multiple ascending oral doses of FOR-6219. Results are expected at the end of 2018.
"Commencing the first clinical study of FOR-6219 marks an important milestone for Forendo Pharma. FOR-6219 has the potential to address significant unmet needs in women's health, and potentially offers multiple benefits over the current endometriosis therapies including long term use as well as the opportunity for earlier intervention to this chronic disease. We are excited by the significant clinical applications and commercial opportunities it holds for Forendo Pharma," said Risto Lammintausta, CEO of Forendo Pharma.
Forendo has developed a potential new treatment for endometriosis based on inhibition of the HSD17B1-enzyme, a novel drug target for tissue specific regulation of hormone activity. Proof of efficacy for this novel mechanism has been demonstrated in primate model of endometriosis.
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. They often lead to systemic estrogen depletion, with known safety issues on bone mineral density and menopausal symptoms.
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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 nine 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.
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SOURCE: Karolinska Development AB (publ)