Therapy Areas: Central Nervous System
Saniona announces continuation of cocaine addiction study with NS2359 by UPenn Treatment Research Centre at higher dose
24 January 2019 -

Saniona AB (STO:SANION), a biotechnology company, announced on Wednesday that the University of Pennsylvania Treatment Research Centre (TRC) plans to continue the ongoing phase 2a study for NS2359 in cocaine addiction at a higher dose.

Reportedly, TRC's decision is based on an interim analysis of the blinded data for the first 50 patients enrolled.

According to Saniona, while the blinded interim analysis was not aimed at detecting statistically significant differences between the treatment groups (placebo versus NS2359), the investigators concluded that there was sufficient support to warrant continuation of the study at a higher dose.

Now, since the study will be continued, the results and data remain blinded. In general, NS2359 appeared to be well tolerated and data from other studies supports the use of higher doses to exploit the full potential of the drug in this indication.

Both Saniona and the TRC believe there is good scientific rationale, supported by preclinical and clinical evidence, for NS2359 to combat cocaine addiction and alcohol abuse, which are significant public health problems and potentially important commercial opportunities for Saniona. Therefore, the company is pleased that TRC plans to continue this investigator-initiated study.

This phase 2a study is funded by non-dilutive grants and conducted by TRC at the University of Pennsylvania's treatment facility at the PENN / VA Centre for the Studies of Addiction (CSA). Saniona has provided NS2359 drug substance for the trial.

This double blind, placebo-controlled study comprises a total of up to 80 patients, where half of the patients receives NS2359 and half of the patients receive matching placebo for a total of eight weeks. TRC has performed an interim analysis following the completion of 50 patients. The study is supported by grants from the Dana Foundation and the Groff Foundation.

Saniona is a research and development company focused on drugs for diseases of the central nervous system and eating disorders. The company has four programmes in clinical development.

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