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Saniona initiates Phase 2a study

Drejer Saniona

Saniona, a biotech company in the field of ion channels, has announced that the University of Pennsylvania Treatment Research Center (TRC) has initiated recruitment of patients in a Phase 2a study for their compound, NS2359, for treatment of cocaine addiction.

Today there are no approved drugs to treat cocaine addiction. The trial comprises a total of up to 80 patients.

“We are very excited about the initiation of this important Phase 2a study. TRC is world class within clinical trials on drug addiction. The two principal investigators are recognized leaders in addiction research. Dr. Berrettini is an internationally-recognized expert in the genetics of addiction and Dr. Kampman is a highly respected top researcher in conducting clinical studies of cocaine addiction. TRC has secured funding for initiation of this trial which demonstrates their commitment and belief in the concept” says Jørgen Drejer, CEO of Saniona.

“Cocaine addiction is a significant public health problem, responsible for substantial medical, psychiatric, and economic costs. There are no medications proven efficacious for the treatment of cocaine addiction. The development of an effective pharmacotherapy for cocaine-addicted patients has the potential to significantly impact the public health by addressing the needs of hundreds of thousands of Americans,” says Kyle M. Kampman, MD, Medical Director of the TRC.

“We are eagerly looking forward to test NS2359 for treatment of cocaine addiction. The scientific rational is clear and supported by preclinical and clinical evidence. We believe that NS2359 may be able to reduce cocaine craving and blunt the euphoric effects of cocaine without causing euphoria itself. Therefore, NS2359 represents a very promising candidate, which would be the first approved drug to treat cocaine addiction,” says Dr. Wade Berrettini, principal investigator at University of Pennsylvania.

The study is conducted by TRC at the University of Pennsylvania’s treatment facility at the PENN / VA Center for the Studies of Addiction (CSA). The primary objective of the Phase 2a study is to examine whether NS2359 leads to abstinence from cocaine during the last 2 weeks of treatment. The secondary objective is to investigate whether NS2359 provides a reduction in craving for more cocaine, a reduction in withdrawal symptoms, a reduction in alcohol consumptions and smoking and whether NS2359 provides improved cognitive ability. The double blind, placebo controlled study comprises a total of up to 80 patients, where half of the patients will receive NS2359 and half of the patients will receive matching placebo for a total of 8 weeks.  All patients will be offered weekly individual therapy sessions in relation to the trial.

On May 31 the company obtained the remaining portfolio from NeuroSearch and the company was approved for listing on Nasdaq First North Premier on Mat 16.