IBSA Group and Granata Bio announces first patient screened in pivotal PROGRESS clinical trial of Progesterone-IBSA
BOSTON, Oct. 20, 2022 -- IBSA Group and Granata Bio today announced the screening of the first patient in the pivotal phase III PROGRESS (PROGesterone fRozen Euploid blaStocyst tranSfer) clinical trial (Clinical Trials.gov Identifier: NCT04549116).
The PROGRESS study is a multicenter, randomized, controlled, double-blind, double-dummy study to evaluate the safety and efficacy of subcutaneous progesterone compared to vaginal progesterone for luteal phase supplementation in modified natural frozen euploid blastocyst transfer. The study is expected to enroll about 680 patients between the ages of 35-42 years old.
"The IBSA Group is excited for this key milestone in development of our subcutaneous progesterone in the United States. It has been approved in Europe since 2014 and continues to outperform our expectations in Europe and rest of world," stated Giuseppe Mautone, Head of R&D Scientific Affairs of IBSA Group.
The Center for Disease Control and Prevention reported around 326,000 Assisted Reproductive Cycles (ART) performed in 2020. ART use has more than doubled over the past 10 years. About 13% of all women aged 15 to 49 years have difficulty getting pregnant or carrying a pregnancy to term.1
"There is certainly room for improvement in the currently approved therapies for luteal phase support in the United States", said Evan Sussman, Co-founder and CEO of Granata Bio. "The PROGRESS trial should contribute important evidence - in the setting of a modern ART protocol - to help evaluate the efficacy, safety, and tolerability of a new injectable progesterone formulation."
About Progesterone-IBSA
Progesterone-IBSA is a proprietary aqueous progesterone hydroxypropyl betadex solution for subcutaneous injection, developed and manufactured by IBSA. The drug product is currently approved for marketing in 50 countries under the trade names Pleyris®, Lubion® Progiron® and Inprosub®.
Progesterone should not be used in patients with current or past history of thrombophlebitis, thromboembolic disorders, or cerebral apoplexy, liver dysfunction or disease, known or suspected malignancy of breast or genital organs, undiagnosed vaginal bleeding, missed abortion, and/or known sensitivity to progesterone products.
About IBSA Group
IBSA Group, headquartered in Lugano, Switzerland, is a leader in reproductive health and has a diversified product portfolio of prescription drugs and biologics. With products on five continents and in over 80 countries, IBSA has a commitment to scientific research and improving the health of patients.
For more information, visit www.ibsagroup.com
About Granata Bio
Granata Bio is a US-based biopharma company focused on women's health and infertility. Founded in 2018, Granata's pipeline includes collaborations spanning four different fertility medication classes.
For more information, visit www.granata.bio.
1 https://www.cdc.gov/art/artdata/index.html