US-based biopharmaceutical company Sunovion has reported positive results from the Golden-5 trial of SUN-101 (glycopyrrolate) to treat moderate-to-very severe chronic obstructive pulmonary disease (COPD).
SUN-101 is a long-acting muscarinic antagonist (LAMA) bronchodilator, delivered through the patented investigational eFlow nebuliser closed system.
The Phase III Glycopyrrolate for obstructive lung disease via Electronic Nebulizer-5 (Golden) trial is a randomised, open-label, active-controlled, parallel-group, multicentre safety study conducted over a period of 48 weeks.
It has been designed to evaluate the safety and tolerability of SUN-101 when administered to adult patients with COPD.
The study had involved 1,087 patients across the US and Europe.
In the trial, SUN-101 was administered on a twice-daily regimen to patients along with its comparator, Spiriva (tiotropium bromide) delivered once-daily.
The trial was primarily focused on determining the safety of the product depending on the basis of number and percentage of study participants with treatment-emergent adverse events (TEAE), the number and percentage of study participants with treatment-emergent, serious adverse events (SAE) and the number and percentage of study participants who discontinued the study due to TEAEs.
The secondary endpoint was to determine the mean change from baseline more than 48 weeks in trough forced expiratory volume in one second (FEV1) for all subjects and number and percentage of subjects with major adverse cardiovascular events (MACE).
Results suggested tolerability of SUN-101 when administered on a twice-daily regimen, as well as incidence of MACE similar to that of active comparator Spiriva.
Sunovion executive vice-president and chief medical officer Antony Loebel said: “The results from the GOLDEN-5 study further build on the strong safety and efficacy profile we have seen in our previous Phase III studies, and we look forward to advancing SUN-101 / eFlow through the regulatory process as the first nebulised LAMA for patient use.”
The company is planning to file a new drug application (NDA) of SUN-101 to the US Food and Drug Administration (FDA).
Image: Chest X-Ray displaying severe COPD. Photo: courtesy of James Heilman, MD.