MORRISVILLE, N.C.– Arrivo BioVentures announced today that the company has closed enrollment of a phase 2 clinical study with its most advanced program, SP-624, after having enrolled more than 300 patients with major depressive disorder. Arrivo expects top-line data in early Q4 2022.
The study is a multicenter, double-blind, randomized, placebo-controlled study of the safety and efficacy of SP-624 in the treatment of adults with major depressive disorder. The trial is being conducted across 39 clinical trial sites in the United States with a total of 319 patients enrolled. Patients were randomized to either SP-624 or placebo once daily for four weeks. The primary endpoint is the change from baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) total score. There are also a number of standard measures as secondary endpoints for the study.
SP-624 is a novel, small molecule that selectively activates a novel epigenetic mechanism known to modulate gene expression, metabolism and DNA repair. SP-624 enhances neuroplasticity in the hippocampus and augments neurotransmitter release in the prefrontal cortex in animal studies. Augmented neurotransmitter release is understood to be a key feature of many first line anti-depressants while enhanced neuroplasticity holds the potential to reprogram cell function and produce long-lasting effects.
Arrivo’s portfolio also includes three other promising drug candidates. DLX-105 is single-chain variable fragment the company is delivering topically to directly treat mild to moderate plaque psoriasis. DLX-105 is currently in a small proof-of-concept study with data readout expected in mid-2022. DLX-2323 is a single-chain variable fragment inhibitor of IL-1β. IL-1β is a potent cytokine and an important mediator of acute and chronic inflammation. Finally, Arrivo is developing RABI-767, potentially the first treatment for severe acute pancreatitis. Arrivo has now taken over the lead from its strategic development partner, Lamassu Pharma, LLC, and the drug is entering the clinic in 2022.