Contineum announces topline data from PIPE-791 trial

Contineum (CTNM) announced topline data from its PIPE-791 Phase 1b positron emission tomography trial. The trial met its primary objectives by demonstrating PIPE-791, the company’s novel, brain penetrant, small molecule antagonist of the lysophosphatidic acid 1 receptor, achieved high brain receptor occupancy in healthy volunteers and progressive multiple sclerosis patients with a clear pharmacokinetic correlation between drug exposure and receptor engagement. PIPE-791 also demonstrated a safety and tolerability profile consistent with the company’s previous clinical studies. Based on these data, the company believes its planned doses for its future Phase 2 proof-of-concept clinical trials in idiopathic pulmonary fibrosis and PrMS will exceed 90% target coverage at trough with once daily dosing. A PK relationship between PIPE-791 exposure and LPA1 brain RO was confirmed in healthy volunteers and PrMS patients. Plasma EC50 values 37 ng/mL at 24 hours and 12 ng/mL at 168 hours post-dose demonstrate sustained target engagement in healthy volunteers. The company believes its planned doses for its future Phase 2 proof-of-concept clinical trials will exceed 90% target coverage at trough with once daily dosing. Although direct measurement of LPA1 RO in the lungs of healthy volunteers was not feasible in the company’s Phase 1b PET trial, likely due to low receptor expression in healthy volunteers combined with technical challenges associated with lung PET imaging, the company’s earlier preclinical studies have demonstrated a strong correlation between brain and lung RO.