QP Completes Phase 1 Clinical Trial in Healthy Volunteers

February 1, 2024

QP is pleased to share the completion of its Phase 1 clinical trial to assess the bioequivalence and food effect bioavailability of its investigational product, a Lumacaftor mono-substance tablet (NCT05968612). The trial was conducted with 39 healthy adult volunteers in December 2023, with top-line results expected in Q2 2024. The outcome of this Phase 1 clinical trial is expected to facilitate forthcoming Phase 2 LYRIC-HF clinical trial in heart failure patients.

Classically used in the treatment of cystic fibrosis, QP is exploring a new use for CFTR-corrector therapy compounds as a candidate treatment for brain blood flow deficits in diseases including heart failure and subarachnoid hemorrhage. Paired with preclinical efficacy data and an encouraging safety profile, the Phase 1 results will support the company’s repurposing strategy and the transition to Phase 2 proof-of-concept studies. Dr. Steffen-Sebastian Bolz, Co-Founder and CSO/CMO of QP said, “QP recently made the big leap from preclinical models to its first clinical trial - an impressive milestone for the team - and we look forward to announcing the results of our Phase 1 study in the coming months”.

Phase 1 Trial Design

The Phase 1 single-dose, randomized, open-label, three-way crossover was conducted at a single-centre in Toronto, Canada. Subjects were randomized to one of three treatment sequences to evaluate a single oral dose of QP’s Lumacaftor tablet under fasted and fed conditions, and a single dose of the reference product (lumacaftor/ivacaftor) under fed conditions. Following each dose, blood samples were collected at 17 timepoints over a 72-hour period (pre-dose (0) at 0.25, 0.5, 0.75, 1, 2, 3, 4, 5, 6, 7, 8, 9, 12, 24, 48, and 72).

Other News