Development of a Novel Biologic to Treat Preeclampsia

PreeclampsiaPEis a pregnancy induced hypertensive disorder without an effective treatmentThe goal of this project is to produce a safe and effective biologic for treatment of very preterm PEPE is the leading cause of pregnancy related morbidity and mortality in the USaffecting overpregnant women and newborns annuallyat a significant cost to the healthcare system and lifelong consequencesPE is characterized by the new onset of hypertension and can lead to more serious complicationssuch as seizureeclampsiaand HELLP syndrome associated with systemic organ failure and deathCurrent interventions to treat PE include magnesium sulfate as an anticonvulsant and antihypertensive drugswhich may manage symptoms but do not target the underlying causes of the diseaseOne potential cause of PE is an imbalance of angiogenic factorsspecifically antiangiogenic sFltand proangiogenic PlGFHigher sFltPlGF ratios correlate with increased severity of disease and poor clinical outcomeThe product of this SBIR will be recombinant human PlGF proteinrhPlGFas a replacement therapy to treat very preterm PE and prolong pregnancy without adverse maternal or fetal effectsThe long term goal is to develop and commercialize a safe therapeutic for very preterm PE to improve health outcomes by reducing maternal symptoms and extending fetal gestation toward rtweeksFor SBIR Phase Iwe successfullyexpressed and purified rhPlGF then demonstrated that rhPlGF can bind endogenous free sFltin PE serum in vitroandshowed efficacy in the RUPP rat model of PE in vivoas rhPlGF restored circulating free sFltblood pressure and renal function towards normal pregnant levelsFor SBIR Phase IIwe willdemonstrate that rhPlGF can be safely administered in third trimester pregnant non human primates without toxicityandcomplete a cGMP manufacturing campaign for use in a Phase I clinical studyAfter the SBIR Phase IIAggamin has plans for a clinical trial partnership and commercialization with an established pharmaceutical companyPE affectsof all pregnancies and disease incidence is rising as risk factors such as obesitydiabeteswomen s age at pregnancyand rate of multiple births increaseThe market for Aggamin s treatment for preterm PE casesevident beforeweeksis estimated at up topatients worldwideand could later increase to include PE cases where symptoms appear afterweeksReimbursement rates will be justified by reducing or eliminating neonatal ICU costs and improving health outcomes for the newborn and motherThe total market for Aggamin s therapeutic product to treat very preterm PE cases in the US is estimated at $billionThe rhPlGF replacement therapy will be a first in class treatment for PEand if proven safe and effectiveits medical and commercial value will be substantial