ObsEva has started a proof-of-concept clinical trial of its compound OBE022’s ability to prevent or delay premature births, which are associated with the development of cerebral palsy and other neurological conditions.
The population in the Phase 2a study, called PROLONG, will be women who start labor 24 to 34 weeks after becoming pregnant. A proof-of-concept study is one that looks at whether a treatment approach is feasible.
Researchers said the women in the trial will receive OBE222 for seven days while on a standard treatment regimen that includes labor-suppressing drugs. A full-term pregnancy is 38 to 40 weeks.
OBE022 blocks the PGF2-alpha protein receptor, which researchers believe is involved in triggering labor. Research so far has suggested that OBE022 reduces inflammation, decreases uterus contractions and prevents cervical changes and membrane ruptures.
Current medications target other molecules involved in labor. But they are not effective enough and can have toxic side effects for both the mother and child.
“OBE022 is a selective PGF2α receptor antagonist that we believe could be a promising new treatment for delaying or preventing preterm birth,” Dr, Ernest Loumaye, ObsEva’s CEO, said in a press release.
There will be parts to the trial. Part A will be at Helsinki University Women’s Hospital in Finland, one of Europe’s largest maternity hospitals.
It will include about eight women. Researchers will analyze OBE022’s safety and properties in the body before moving on to the larger Part B stage.
“We are very pleased to be conducting the PROLONG trial at the Helsinki University Women’s Hospital,” said Seppo Heinonen, the hospital’s director of obstetrics and gynecology. “There is a major need for new treatments for preterm labor and we are very excited to be testing the first compound in this promising new class.”
In part B, 120 patients will be randomly assigned to either OBE022 or a placebo. Researchers will continue evaluating the therapy’s safety, but will also look at how effective the drug is at preventing preterm birth.
The team will monitor the women until delivery and both the mothers and infants for 28 days after birth. After that, babies will be followed for two years.
Measures to be assessed include the number of patients who deliver at two or seven days after starting OBE022 treatment, the number of deliveries at week 37, and the time between treatment and delivery.
ObsEva expects preliminary results on 60 of the Part B patients to be available by late 2018.