Insmed, Premacure report positive results for trial of potential ROP treatment

RICHMOND, Va. — Insmed and Premacure have reported positive results from a phase 1 study evaluating the efficacy, safety and tolerability of a novel treatment for infants with retinopathy of prematurity, according to a joint press release from the companies.

The drug, called Iplex, is a complex of recombinant human insulin-like growth factor-I (rhIGF-I) and its predominant binding protein IGFBP-3 (rhIGFBP-3) that has been approved in the United States for treating children with growth failure secondary to severe primary IGF-I deficiency, the release said.

The open-label, investigator-sponsored clinical trial evaluated the ability of the protein complex for increasing serum to normal levels of rhIGF-I and rhIGFBP-3 when administered intravenously in significantly premature infants with a gestational age between 26 and 29 weeks and birth weights between 810 g and 1,310 g.

All Iplex administrations took place on the infant's chronological age day 3, the release said.

The investigators reported that Iplex effectively increased serum IGF-I levels into the normal range and was well-tolerated, with no acute adverse events.

Study results were reported at the European Society for Pediatric Endocrinology annual meeting in Istanbul, Turkey, according to the release.

Premacure plans to initiate a phase 2, multicenter trial of the drug for treating ROP later this year, according to the release.

Iplex is being developed by Premacure through a Material Transfer Agreement with Insmed.