APT-1011 shows clinical activity in teens, adults with eosinophilic esophagitis
The orally disintegrating tablet formulation of fluticasone propionate, APT‐1011, is safe and well tolerated in adolescents and adults with eosinophilic esophagitis (EoE), according to the results of a phase Ib/IIa trial. Treatment produces improvements in both endoscopic and histologic findings, as well as symptoms.
The trial randomized patients to receive APT‐1011 1.5 mg twice a day (n=8; mean age, 23.4 years) or 3.0 mg once daily (n=8; mean age, 24.6 years) or placebo (n=8; mean age, 29.8 years) for 8 weeks. A higher proportion of patients in the placebo than in the active treatment groups had continuous dysphagia. More than half of the overall population continued to use PPI therapy during the study. Twenty-two patients completed treatment.
APT-1011 was well tolerated, and there were no demonstrable safety concerns with dosing at 1.5 mg BID and 3.0 mg QD in adolescents and adults. There were no reports of deaths, serious treatment‐emergent adverse events (TEAEs), severe TEAEs or treatment discontinuations due to a TEAE. One patient in the 1.5-mg APT‐1011 arm showed a reduction in cortisol, although there was no evidence of adrenal insufficiency.
In terms of efficacy, treatment with APT‐1011 vs placebo led to more favourable improvements in oesophageal eosinophil counts, EoE Endoscopic Reference Score, patient global assessment and symptom‐based EoE activity index from baseline to week 8.
The present data support the continued development of APT‐1011 for the treatment of EoE.