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- OBE022 is
"We are very pleased with the results of this Phase 1 drug-drug interaction study which supports our initiation of a Phase 2a study commencing later this year for the treatment of preterm labor. These data support the co-administration of OBE022 with tocolytics to prevent pre-term birth, as well as standard of care to improve the neonatal outcome of the premature baby." said Jean-Pierre Gotteland, CSO of
OBE022 is a first-in-class, once daily, oral and selective prostaglandin F2alpha (PGF2alpha) receptor antagonist, which is in development for the treatment of preterm labor in weeks 24 to 34 of pregnancy. Based on pre-clinical models, OBE022 may potentially match the known tocolytic efficacy of prostaglandin inhibitors without the serious safety concerns reported with non-specific compounds such as indomethacin or other NSAIDs.
Patients with threatened preterm delivery are usually treated with MgSO4 for fetal neuroprotection, betamethasone for accelerating fetal lung maturation and a tocolytic to suppress uterine activity. More than one tocolytic may be used in combination or sequentially if the primary choice is not effective. The combination of tocolytic treatments could potentially lead to additive or synergistic effects on uterine contractions. As a result of the limited efficacy and unfavorable safety profile of many current tocolytics used off-label to treat preterm labor, we believe there remains a significant unmet need for a selective prostaglandin inhibitor. Focus on the inhibition of only PGF2alpha to delay preterm birth may provide a safe treatment option for both mother and child.
The drug-drug interaction Phase 1 clinical study was a randomized, open-label, single-centre Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of OBE022 when co-administered with MgSO4, betamethasone, atosiban, or nifedipine to pre-menopausal healthy women. The study was performed in two parts: (A) single dose of OBE022, 12 hours MgSO4 infusion and co-administration of both, each separated by 7 days; (B) single dose of each of atosiban, nifedipine and betamethasone followed by co-administration of each of these compounds with multiple doses of OBE022.
All studied OBE022 combination treatments were safe and well-tolerated. All but one treatment emergent adverse events (TEAE) were mild, one was moderate; there were no serious adverse events and no clinically relevant changes in safety parameters. No clinically significant abnormalities were detected in clinical laboratory results and the ECG assessments including QTcF evaluation did not reveal any clinically significant abnormalities.
Single and steady state pharmacokinetics of OBE022 and its readily formed active stable metabolite OBE002 in pre-menopausal women were comparable to those in the Phase 1 first-in-women study with post-menopausal women. There were no clinically relevant interactions between OBE022 and MgSO4, betamethasone or atosiban while nifedipine exposure was increased.
Given the results announced today,
About Preterm Labor
Preterm labor, defined as the body commencing the birthing process prior to 37 weeks, is a serious women's pregnancy health condition characterized by uterine contractions, cervical dilation and rupture of the fetal membranes that surround and protect the fetus during pregnancy. According to a study published in the Lancet in 2012, approximately 15 million babies were born before 37 weeks of gestation in 2010, accounting for 11.1% of all live births worldwide. Over 1 million children under the age of five died in 2013 worldwide due to preterm birth complications, and many infants who survive preterm birth are at greater risk for cerebral palsy, delays in development, hearing and vision issues, and often face a lifetime of disability. The rates of preterm births are rising in almost all countries with reliable data for preterm birth, and are associated with an immense financial impact to the global healthcare system.
To date, preterm labor is a condition for which only treatments with limited efficacy or restrictive safety issues are available. In
About OBE022 and PGF2alpha
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