Sandra E. Reznik, MD, PhD, Section Director, Perinatal Pathology, Montefiore Einstein, and Associate Professor, Pathology and Obstetrics & Gynecology and Women’s Health, Albert Einstein College of Medicine, was investigating a drug to prevent preterm birth and discovered that a common, inactive ingredient in many pharmaceuticals could work on its own to prevent early labor and delivery. In May, she successfully patented the use of N,N-Dimethylformamide (DMA) to prevent preterm birth.
Through a four-year grant from the National Institute of General Medical Sciences (NIGMS), Dr. Reznik and colleagues at St. John’s University will test a newly patented treatment that could benefit millions of at-risk women and infants by reducing preterm births in communities like the Bronx, where the rate of early labor is higher than the national average.
“A couple of years ago, I made an accidental discovery that this convenient, inexpensive, non-toxic, readily available solvent might work, but decided to pursue it in a systematic way,” said Dr. Reznik, who recently celebrated her 25th year at Montefiore Einstein. “And now we’ve been able to show that DMA prevented preterm birth in mice—without any harm to the mother or her pups.”
Preterm birth is a serious clinical problem, with infants born before 37 weeks of pregnancy being more likely to have breathing and feeding problems, developmental delays, hearing and vision impairment and debilitating disorders like cerebral palsy. Babies born before 32 weeks have significantly higher rates of death and disability, according to the Centers for Disease Control and Prevention (CDC). CDC data show the preterm birth rate for Black women is about 50% higher than that for white women. In 2021, one in nine babies in the Bronx—and 13% of Black infants—were born preterm, according to the March of Dimes.
DMA is commonly used as a solvent to convert drugs from solids to liquid formulations that can be easily administered by intravenous drip or injection. Dr. Reznik made her discovery while performing standard safety testing in preparation for combining DMA with potential drug candidates for stopping preterm birth in mice. She found that DMA stops the cervix from softening and opening by suppressing inflammation, the most common trigger of spontaneous preterm labor.
The main aim of the NIGMS grant is to compare two different ways of administering DMA, by injection into the abdominal cavity or directly into the vagina. The direct application is a targeted drug delivery system using lipid nanoparticles (LNPs) to transport the DMA molecules. The formulation starts as a liquid, which is administered by dropper into the vaginal canal, where it becomes a gel that coats the cervix. This delivery method could have significant benefits as the drug does not cross the placenta, making it less likely to affect the baby. Fear of birth defects has made it historically difficult to win Food and Drug Administration (FDA) approval for any drugs given to pregnant women, Dr. Reznik said.
DMA could make waves beyond obstetrics. Because it is a small molecule that does cross the blood-brain barrier, Dr. Reznik sees potential for treating neurological disorders like Alzheimer’s disease.
“Across the cycle of life, from the earliest stage to the end, there may be a role for DMA,” she said.