Stellenbosch University has launched a clinical trial to evaluate DM199 as a potential treatment for preeclampsia, a life-threatening pregnancy complication. The trial, named "DM199 for Pregnancy Complications," enrolled its first participant on November 13 and is led by Professor Cathy Cluver at the Preeclampsia Research Unit.
Preeclampsia affects approximately 5% of all pregnancies and is characterized by high blood pressure and end-organ damage, typically emerging in the second half of pregnancy. Globally, it leads to over 70,000 maternal deaths and half a million fetal deaths annually. Current treatments primarily focus on managing blood pressure, but DM199 takes a different approach by targeting the underlying cause of the condition: endothelial dysfunction.
DM199: A Novel Approach to Preeclampsia Treatment
DM199 is a synthetic version of tissue-kallikrein-1, a naturally occurring protein. It is designed to improve blood vessel health by addressing endothelial dysfunction, which is central to the development of preeclampsia. A key advantage of DM199 is its molecular size; as a large protein, it is less likely to cross the placental barrier, potentially offering a safer profile compared to existing antihypertensive medications.
"This is the first time we've been able to test a new drug for preeclampsia treatment," said Professor Cluver. "DM199 shows remarkable potential."
Trial Design and Safety Measures
The clinical trial will proceed in stages, beginning with a dose-finding study. Initially, three women will be treated consecutively, with incrementally increasing dosages to determine the optimal and safest concentration of DM199. The primary goals are to establish an appropriate dosage and to ensure the drug does not negatively impact the unborn child.
"We're starting with an ultra-low dose and will closely monitor for safety," Professor Cluver explained.
Addressing a Critical Gap in Maternal Healthcare
Historically, the development of pharmaceuticals for pregnancy-related complications has been hindered by concerns about potential harm to the fetus. This has left pregnant women with complex conditions, like preeclampsia, with limited treatment options. This trial represents a significant step forward in addressing this gap, offering hope for a more targeted and effective approach to managing one of pregnancy's most dangerous complications.
