In the fall of 2024 in Cape Town, South Africa, 33-year-old Abigail Hendricks developed dangerously high blood pressure and proteinuria late in pregnancy, signs of preeclampsia that put both her and her unborn child at risk. Treated at Tygerberg Hospital, she enrolled in a clinical trial of an experimental drug called DM199; after receiving the infusion, her blood pressure stabilized and she delivered a healthy son. The small early trial, led by researchers at Stellenbosch University, reports that DM199 appears to calm blood-vessel injury without obvious transfer across the placenta or into breast milk. Investigators and outside maternal-fetal specialists say the results are encouraging but preliminary, and larger, more diverse studies are needed to confirm safety and benefit for mothers and babies.
Key takeaways
- Trial signal: In a small dose-escalation study at Tygerberg Hospital, the 16th patient—and subsequent participants—showed rapid and sustained blood-pressure declines after DM199 infusion.
- Patient scope: The trial enrolled at least 24 patients at the Cape Town site; early cohorts (first 15) did not show a clear effect at lower doses.
- Clinical setting: Tygerberg handles roughly 8,000–9,000 deliveries annually for predominantly high-risk patients, making it a high-volume center for testing interventions in severe pregnancy complications.
- Safety signals: Preliminary lab tests reported by investigators indicate DM199 does not appear to cross the placenta or show up in breast milk samples from treated mothers.
- Global burden: Preeclampsia is a leading cause of maternal mortality worldwide, contributing to at least an estimated 42,000 maternal deaths each year.
- External expert view: Independent maternal-fetal specialists caution that the study is small and emphasize the need to test whether the drug can safely prolong pregnancy and improve neonatal outcomes.
Background
Preeclampsia is a pregnancy disorder driven by abnormal placental signals that provoke systemic blood-vessel damage and hypertension in the mother. The condition can progress to eclampsia, marked by seizures, and may cause fluid overload, pulmonary edema, multi-organ injury and hemorrhage — threats to both mother and fetus. Clinically, the dilemma is that many standard antihypertensive agents lower maternal blood pressure but can also reduce uteroplacental blood flow, potentially worsening fetal oxygenation.
Management strategies typically revolve around tight monitoring, blood-pressure control and, when maternal or fetal risk is high, delivery. For hospitals that care for many high-risk pregnancies, including Tygerberg, clinicians often aim to safely delay delivery to allow fetal maturation but must balance that goal against escalating maternal danger. Decades of research have sought a therapy that both protects maternal vasculature and preserves or improves uteroplacental circulation; to date, no approved pharmacologic agent has fulfilled both aims.
Main event
Researchers at Stellenbosch University, led by professor Cathy Cluver, partnered with DiaMedica Therapeutics to test DM199 — a biologic initially investigated for certain strokes — in pregnant patients with severe hypertension who were scheduled for early delivery. The trial used incremental dosing cohorts; investigators observed no meaningful change in blood pressure during the first 15 low-dose enrollments. When the 16th enrollee received a higher dose, clinicians noted a rapid stabilization of previously elevated readings.
Following that dose level, subsequent participants given the same or slightly higher doses exhibited similar blood-pressure improvements. Study staff described the change as marked and sustained over the observation period. Laboratory sampling undertaken as part of the protocol found no detectable drug in placental tissue assays and no measurable compound in breast-milk samples, suggesting limited fetal exposure in these early cases.
Among those enrolled was Abigail Hendricks (patient number 24 at the Cape Town site). After the infusion and careful monitoring at Tygerberg, clinicians proceeded with induction and delivery several weeks before term; her son Hayden was born vigorous, and both mother and baby were reported to be well months later. For clinical staff and trial nurses, the outcome underscored the potential for a therapy that might reduce immediate maternal risk while preserving neonatal health.
Analysis & implications
If replicated in larger, controlled trials, a drug that both stabilizes maternal blood pressure and improves or preserves placental perfusion would change clinical practice. Current therapy often forces clinicians into a zero-sum trade-off: protect the mother at the cost of fetal oxygen delivery, or delay delivery and risk maternal decompensation. A successful pharmacologic approach that targets endothelial stabilization could shift that balance, allowing safer prolongation of pregnancy when clinically appropriate.
However, early-phase trials are designed to assess safety and pharmacology more than definitive clinical benefit. The Cape Town experience indicates a strong signal in a specific, severely ill subgroup of patients receiving the drug in the hours or days before planned delivery. It does not yet answer whether DM199 can be used earlier in pregnancy to delay preterm birth or improve long-term neonatal outcomes such as respiratory morbidity or neurodevelopment.
Regulatory and implementation pathways will require multicenter randomized trials across diverse populations, robust adverse-event surveillance, and attention to endpoints that matter to patients: maternal survival and morbidity, gestational age at birth, and neonatal outcomes up to and beyond discharge. Cost, manufacturing scale and access will also determine whether any approved therapy meaningfully reduces the global burden of preeclampsia, particularly in low- and middle-income settings where mortality remains concentrated.
Comparison & data
| Metric | Value | Context / Source |
|---|---|---|
| Annual maternal deaths from preeclampsia | ~42,000 | Global estimate cited by researchers |
| Tygerberg annual deliveries (high-risk) | 8,000–9,000 | Stellenbosch University / Tygerberg clinical volume |
| Trial enrollments at Cape Town site (reported) | ≥24 patients | Stellenbosch investigator report |
| Noted dose-response turning point | patient 16 (higher dose) | Investigators observed first clear effect |
| Estimated facility prevalence (external) | up to 10% | External clinician estimate for some U.S. centers |
The table summarizes the core numeric context around the trial and the condition it aims to treat. The small sample size and single-site early observations limit generalizability; the apparent dose threshold seen in the Cape Town cohort highlights the need for formal dose-ranging and randomized comparison arms to quantify benefit and risk.
Reactions & quotes
Clinical leaders at the trial site emphasized cautious optimism while noting the limits of early data. The following encapsulates the tone from investigators and outside experts.
“We saw sky-high pressures come down rapidly after an infusion at a higher dose — it was unexpected and compelling,”
Cathy Cluver, professor of obstetrics and gynecology, Stellenbosch University (trial lead)
Cluver described the ward atmosphere and the emotional weight of treating very sick pregnant women; she framed the finding as a potential first step toward a treatment that could protect both mother and fetus but emphasized the need for more evidence before clinical adoption.
“At this stage the data show promise, but the study is small and we need larger trials to understand safety and neonatal outcomes,”
Corneila Graves, medical director, Tennessee Maternal Fetal Medicine (external expert)
Graves highlighted the dual importance of maternal safety and placental blood flow, noting that early tests suggesting improved placental perfusion make the approach interesting but not yet definitive.
“The key question is whether a medication like this can safely prolong pregnancy and reduce preterm-related neonatal risks,”
Kara Rood, maternal-fetal medicine physician, Ohio State University (external expert)
Rood stressed a trial design focus on clinically meaningful outcomes—how long pregnancies can be prolonged and whether neonatal morbidity and mortality improve as a consequence.
Unconfirmed
- Whether DM199 can safely be used earlier in pregnancy to prolong gestation and improve neonatal outcomes remains unproven and requires randomized trials.
- Long-term effects on infants exposed in utero or via breastfeeding are not yet established; current tests show no detectable drug in placenta or milk, but sample sizes are small.
- Generalizability to broader populations, ethnic groups and varied health systems is unconfirmed because the reported data come from a single high-risk center and limited patient numbers.
Bottom line
The Cape Town findings represent an important early signal that an investigational drug may both lower severe maternal blood pressure and avoid measurable transfer to the fetus, addressing a long-standing therapeutic gap in preeclampsia care. For patients like Abigail Hendricks, the intervention was followed by a successful delivery and a healthy infant — a human result that resonates with clinicians and researchers.
Yet the evidence is preliminary: small sample size, single-site observations and early dose-escalation design limit confident conclusions about safety and efficacy. The next steps should prioritize well-powered, multicenter randomized trials with robust maternal and neonatal endpoints, careful pharmacokinetic sampling and long-term follow-up to determine whether DM199 or similar agents can alter the global burden of preeclampsia.