During the JPM Healthcare Conference in San Francisco, Zhenya Lindgardt, CEO of Sera Prognostics, sat down with MobiHealthNews to discuss the company’s focus on preventing preterm birth, a leading cause of neonatal mortality, by identifying protein markers that indicate risk.
MobiHealthNews:How does Sera work in women's health?
Zhenya Lindgardt: Sera is a unique company. Any executive dreams of achieving impact, and for a mom of three, leaving my kids, it needs to be for an amazing mission, and it is.
We're focused on pregnancy that affects half of the population, and in any given year, all of the women of childbearing age may become pregnant, and we are focused on preventing preterm birth, which is not as well known as I would like. It is a very prevalent condition. Unfortunately, one out of 10 babies will be born preterm, which is defined as before 37 weeks of gestation and with significant health complications that are associated with that.
Obviously, the health complications are a lot worse if it's a really premature baby that is born, for example, before 28 weeks, versus a baby that is born at 36 weeks, for example. But, those who are born before 28 weeks may spend three or four months in the NICU.
Actually, about a third of mortality in neonates is driven by prematurity. So, it's a leading cause of death for babies. So, it's definitely worthwhile for society to find new solutions to screen for potential preterm birth.
MHN: What is Sera offering regarding preventing preterm birth?
Lindgardt:Sera has mapped over 300 proteins that get expressed by the placenta throughout pregnancy, and we pinpointed markers that specifically point to the risk of preterm birth.
Specific proteins, IBP4 to SHBG, have been shown and get expressed through weeks 18 to 20 of pregnancy, and the ratio between the two of them can help us definitively pinpoint whether the woman is at higher risk for preterm birth. Specifically, it's a ratio between the two proteins, not the absolute quantity of these proteins, because absolute quantity varies dramatically across the phenotype.
No two people are the same, but the ratio of these two proteins is directionally very telling and helps stratify women into those who will be at higher risk and those who are not at higher risk. If you ask me what that threshold is, we validated a threshold of two times the average rate of preterm birth. So, in our test, when we look at the ratio of these two proteins, we draw the line and tell the physician that if the woman is at two times the risk, she is at higher risk for preterm birth. If she is not, she is not.
MHN:What would providers do with that information?
Lindgardt: We turned to the Society for Maternal-Fetal Medicine and key opinion leaders who deal with higher-risk pregnancies, and they helped design an intervention that includes three components: low-dose aspirin (81mg aspirin), vaginal progesterone applied daily and care management – a fancy name for a structured nurse call every week, which, frankly, is better care.
So, that's a three-prong bundle that we tested in three clinical trials: prevent, avert and prime. It just concluded very successfully. It was stopped in the interim.
About a year ago, we got a letter unexpectedly from DSMB [Data Safety and Monitoring Board] that oversaw our trial. They saw the interim data and said, "You can stop the trial. The results look amazing."
By the time we stopped enrollment, we already enrolled 5,000 patients. So just last week, the abstract from that study was published in the pregnancy journal.
We hit both primary and co-primary endpoints, which were the health of the baby and hospital length of stay. So the health of the baby improved by 20% as measured by neonatal mortality and morbidity index, which is a four-point scale – four being, unfortunately, the death of the baby, and one being some light complications for the baby. So, a 20% improvement means that the complications were a lot less severe. Why? Because stratifying the pregnancy early into higher risk versus not higher risk, and deploying the intervention extended gestation and made the baby healthier at birth by exchanging gestation, and therefore the baby gets out of the hospital sooner because it's healthier.
So the second co-primary endpoint was the length of stay in the hospital, and that was improved dramatically also.
MHN: How have providers responded to the study?
Lindgardt:The reception has been very curious and positive, because physicians do not have any tools. They want to be able to screen for preterm birth, because 50% of moms who end up giving birth prematurely don't have any other risk factors. So, there is no way for physicians to spot them and to predict, and this is the most litigated profession, unfortunately, in healthcare, because, of course, as you said, it's a tragedy if you lose a baby or if you have complications for the baby.
So, they are appropriately keen to get verified, robust tools to spot who that woman is at risk that they should pay attention to.
The average appointment length is 15 minutes, and they need to stratify their resources to the mom who needs it the most – but how do they know which mom needs it the most? That's where the test comes in. So, they're very keen to get more tools.
That's why this is so powerful, because you can predict something is going to go wrong and ameliorate its effects before the physician diagnoses a condition or a complication.