Mallinckrodt’s INOmax Improves Oxygenation of Newborns with PH, Interim Study Analysis Shows

Mallinckrodt’s INOmax Improves Oxygenation of Newborns with PH, Interim Study Analysis Shows

INOmax (nitric oxide) gas improved the oxygenation of premature, term, and near-term newborns with pulmonary hypertension (PH) and associated hypoxic respiratory failure, according to data from a interim analysis of Mallinckrodt Pharmaceuticals’ Phase 4, observational PaTTerN registry study.

Persistent PH in newborns occurs when the pressure in the blood vessels supplying the baby’s lungs is high, which can result in a lack of oxygen in the body.

Studies have shown that treatment with inhaled nitric oxide — the active component in INOmax — can improve oxygenation in term and near-term newborns with gestational ages above 34 weeks.

Those findings led the U.S. Food and Drug Administration to approve INOmax treatment for near-term newborns with PH and associated hypoxic respiratory failure (abnormally low levels of blood oxygen), in combination with ventilatory support and other appropriate agents, with a goal of reducing the need for cardiac and extra respiratory support.

In the ongoing Phase 4 PaTTerN study (NCT03132428), researchers are evaluating the efficacy of INOmax in younger patients with PH, specifically premature newborns with gestational ages between 27 and less than 34 weeks, and also in term to near-term newborns with gestational ages from 34 and up to 40 weeks.

The primary outcome of the trial evaluates the incidence of newborns with at least 25% improved oxygenation. To calculate this outcome, researchers assess the babies’ oxygenation index, a parameter often used in intensive care medicine to evaluate oxygen-intake and the severity of hypoxic respiratory failure. In the case of newborns who are not mechanically ventilated, researchers use a surrogate oxygenation index.

The preliminary results of the study (interim analysis) were established at the midway point of enrollment, and included outcomes from 31 premature newborns and 56 term or near-term newborns.

According to the results, about 86% of the newborns in both groups showed oxygenation improvements of 25% or more after treatment with INOmax.

Researchers found no significant treatment-related safety issues at this point in the study.

“We are encouraged to see the results of the interim analysis for this patient population and look forward to learning more as this retrospective, observational registry enrollment progresses,” Steven Romano, MD, executive vice president and chief scientific officer at Mallinckrodt, said in a press release.

“Mallinckrodt is focused on making a difference for underserved patients, including those with critical conditions like neonates with HRF [hypoxic respiratory failure],” Romano added.

The PaTTerN study started enrolling patients in 2017, and completion is expected by 2022. Mallinckrodt aims to enroll a total of 168 patients during the study period.

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