PIQUR kicks-off second clinical trial

Founded in 2011 as a spin-off of the University of Basel, Switzerland, PIQUR Therapeutics is a clinical-stage company developing breakthrough targeted oncology and dermatology medicines for the treatment of cancer and genetic diseases. PIQUR’s lead compound bimiralisib focuses on the dual inhibition of the PI3K/mTOR pathway. Both PI3K and mTOR are clinically validated drug targets in oncology and dermato-oncology.

Following approval by an Independent Ethics Committee in the Netherlands, the company has now kicked off the first human tests in healthy subjects with bimiralisib, followed by patients with the Rare Disease “Cutaneous T-Cell Lymphoma”. The study is run at the Center for Human Drug Research (CHDR) in collaboration with the Cutaneous Lymphoma Expert Centre of the Leiden University Medical Center in the Netherlands. The objective of this single-centre, multiple-stage, multiple-cohort, randomized, placebo-controlled, double-blind clinical study, is to characterize the safety, tolerability, pharmacokinetics, and efficacy of bimiralisib in healthy volunteers and patients with early-stage CTCL.

PIQUR expects to complete the treatment of the healthy volunteer cohort of this combined first-on-human / proof-of-concept study by fall 2019. The local tolerability of bimiralisib will be evaluated using multiple assessments, including daily evaluations of the treated lesions with the Scarletred Vision App by Scarletred.

Phase II study with oral application
Oral bimiralisib has already shown encouraging clinical activity and acceptable safety profile in Phase I/IIa studies in solid tumors and lymphomas.

Recent compelling data supported the initiation of a biomarker-driven (NOTCH1 LoF) phase II study in Head and Neck Squamous Cell Carcinoma (HNSCC). This study (PQR309-009) is currently ongoing. 

(Press release)