Framingham biopharma hopes to rewrite the rules of preeclampsia treatment
Courtesy of rEVO Biologics
Yann Echelard, CEO of rEVO Biologics in Framingham, said he expects to have top-line data on the effectiveness of the company's treatment for preeclampsia by the second quarter of 2016.
Preeclampsia is a leading cause of maternal and infant death worldwide, though the causes are poorly understood, and treatment options are limited.
When an expectant mother develops the disease – which causes high blood pressure, swelling, headache, vision changes and seizures – the normal course of action is to deliver the baby as soon as possible to avoid the potential death of both mother and baby. But when it occurs too early in a pregnancy, that remedy is surrounded by health risks for the baby that could result in life-long problems.
It's a conundrum rEVO Biologics of Framingham is trying to solve. The biopharmaceutical company, which is focused on developing and commercializing treatments for patients with rare, life-threatening diseases, began clinical trials last summer on a drug that may allow women to prolong their pregnancies than what available medicine allows.
rEVO testing patented treatment ATryn in pregnant women
The hope is to avoid deliveries before the 34th week of gestation, when it becomes much safer, according to Yann Echelard, rEVO’s chief executive, who has held various roles at rEVO since 1994.
“When a mother presents with preeclampsia in early pregnancy, there is a balance that has to be found where you try to keep her pregnant as long as possible,” Echelard said in an interview this week.
rEVO’s patented product, ATryn, was approved by the FDA in 2009 but is only used to treat people with a hereditary disorder that causes abnormal blood clots. An ongoing Phase-3 trial was initiated in July, testing the treatment in women who have developed preeclampsia earlier in their pregnancies than usual: between weeks 24 and 28, rather than during the final few week.
According to rEVO’s research, Echelard said extending pregnancy by one day during this four-week span reduces an infant’s stay in a neonatal intensive care unit by an average of five days. That makes prolonging pregnancy more cost effective, while reducing the ill-effects of premature birth.
rEVO, Yale collaborate to launch preeclampsia center
Echelard said rEVO is expecting to have top-line data from the trial that proves ATryn’s effectiveness in patients with preeclampsia by the second quarter of 2016. In the meantime, a new research partnership with Yale University announced this week will help aid the company’s ongoing research, he said. rEVO has awarded a three-year grant of up to $1-million grant to researchers at Yale to establish a “center for advancement” in preeclampsia research.
Research will focus on the short- and long-term burden of preeclampsia for mother and baby with a focus on evaluating treatment options for the condition and related disorders, according to a company statement.
While doctors know the risk factors associated with preeclampsia, such as obesity, hypertension and ethnic heritage, the cause is unknown. Dr. Michael Paidas, vice chair of obstetrics and director of the Yale Women and Children’s Center for Blood Disorders and Preeclampsia Advancement, said the Center of Advancement will improve understanding of the disease.
“Despite significant advances made in preeclampsia, there has been little progress in identifying effective treatment options,” Paidas said in a statement. “Our hope is to improve scientific understanding of the disease that will ultimately lead to better care for women with preeclampsia and their babies.”
The research will be owned by Yale, rEVO staff will be involved, and it should help rEVO and others better understand the disease, according to Echelard.
“We’re not looking necessarily to do research that’s very directed to our current clinical trial. We’re really more interested in understanding, more broadly, preeclampsia,” Echelard said.
Formerly known as Genzyme Transgenics Corp., rEVO was spun out of Genzyme Corp. in the early 1990s, and is now a wholly-owned subsidiary of LFB Biotechnologies, a French pharmaceutical group. The company is located on Crossing Boulevard, just off Route 9 in Framingham, and has manufacturing operations in Chartlon and Worcester as well.
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