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Oral administration of OBE022 shows favorable safety and results in predictable exposure
Non-clinical results of OBE022 for PTL demonstrating fetal safety
- First-in-women (FIW) clinical safety and exposure data following single and multiple oral doses of prostaglandin F2alpha (PGF2alpha) receptor antagonist, OBE022, showing the favorable safety and pharmacokinetic profile of OBE022. In addition, the absence of a clinically relevant effect of food on the absorption of OBE022 will be described (Poster presentation S-038,
Saturday March 10th, 2018).
- Non-clinical reproductive safety and exposure data demonstrating the absence of adverse effects of highly selective PGF2alpha antagonist OBE022 on fetal development in rats and rabbits and on pre- and post-natal development in rats (Poster presentation S-037,
Saturday March 10th, 2018).
"We are delighted to be able to update the scientific community on the progress of our preterm labor drug candidate OBE022." commented Ernest Loumaye, MD, PhD, OB/GYN, CEO and Co-Founder of
"The first administration of a drug candidate to humans always constitutes a major milestone in the development of a drug. Our clinical trial results to date show predictable exposures within the pharmacologically relevant range, including the absence of a food effect that is key for addressing acute PTL. Importantly, results also support an excellent safety profile, with an absence of adverse effects on the fetus, in contrast to nonspecific prostaglandin synthesis inhibitors that may be used as off label tocolytic therapy, such as indomethacin."
In December of 2017,
About Preterm Labor
Preterm labor, defined as the birthing process starting prior to 37 weeks of gestation, is a serious condition characterized by uterine contractions, cervical dilation and rupture of the fetal membranes that can lead to preterm birth. 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, only treatments with limited efficacy or restrictive safety issues are available to treat preterm labor. In the
While prostaglandin inhibitors (NSAIDs) have been shown to be effective for inhibiting preterm labor, use of such drugs is limited, due to the threat of serious and sometimes life-threatening side effects in the fetus. Such side effects may include kidney function impairment, premature constriction of the blood vessel connecting the pulmonary artery and the descending aorta in a developing fetus, and higher risk of thrombosis of the intestinal arteries (a condition called necrotizing enterocolitis).
About OBE022 and PGF2alpha
ObsEva is developing OBE022, a potential first-in-class, once daily, oral and selective prostaglandin F2alpha receptor antagonist, which is designed to control preterm labor by reducing inflammation, decreasing uterine contractions, preventing cervical changes and fetal membrane rupture without causing the potentially serious side effects to the fetus seen with non-specific prostaglandin synthesis inhibitors (NSAIDs). PGF2alpha is believed to induce contractions of the myometrium and also upregulate enzymes causing cervix dilation and membrane rupture. In nonclinical studies, ObsEva has observed that OBE022 markedly reduces spontaneous and induced uterine contractions in pregnant rats without causing the fetal side effects seen with prostaglandin inhibitors such as indomethacin.
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