Saniona announces that FDA has approved the IND for NS2359 in cocaine addiction

Saniona, a leading biotech company within ion-channel research, announces today that the US Food and Drug Administration, FDA, has accepted the University of Pennsylvania Treatment Research Center’s (TRC) Investigational New Drug Application (IND) for NS2359. TRC is currently applying for public funding with the aim of conducting a Phase 2 clinical trial for NS2359 for treatment of cocaine addiction.

Saniona informed on June 4, 2015, that it has granted TRC rights to perform a phase 2 clinical trial for cocaine addiction and that TRC has filed an IND based on drug substance from Saniona and a cross-reference to Saniona’s existing IND comprising a significant package of preclinical and clinical data.

FDA has now informed that they have completed the review of TRC’s submission and concluded that the clinical trial may be initiated. This means that TRC’s IND now is open for Phase 2 in cocaine addiction.

TRC has manufactured drug product (clinical materials to be used in the trial) based on drug substance from Saniona. In addition to this, TRC has performed stability studies on the drug product and developed the protocol for the Phase 2 clinical trial which makes part of their IND submission. TRC is currently seeking public funding in order to perform a clinical proof-of-concept study for NS2359. The objective is to demonstrate efficacy in preventing relapse in cocaine abstinent patients.

“We are very impressed about the commitment and professional approach of TRC, which has led to the approval of the IND within a very short time. TRC is now seeking public grants to support the trial. This is a lengthy process where the time line is subject to official application schedules and outside the control of TRC. Therefore, it is not possible to provide a time schedule for the potential initiation of this trial,” says Jørgen Drejer, CEO of Saniona.

For more information please contact

Thomas Feldthus, EVP and CFO, Saniona, Mobile: +45 2210 9957, E-mail: tf@saniona.com

About Saniona

Saniona is a research and development company focused on drugs for diseases of the central nervous system, autoimmune diseases, metabolic diseases and treatment of pain. The company has a significant portfolio of potential drug candidates at pre-clinical and clinical stage. The research is focused on ion channels, which makes up a unique protein class that enables and controls the passage of charged ions across cell membranes. Saniona has ongoing collaboration agreements with major pharmaceutical companies including Pfizer Inc., as well as Saniona’s Boston based spinout Ataxion Inc., which is financed by Atlas Venture Inc. and Biogen Idec Inc. Saniona is based in Copenhagen, Denmark, where it has a research center of high international standard and 18 employees. Saniona is listed at AktieTorget since April 2014 and has about 2,000 shareholders. The company’s share is traded under the ticker SANION. Read more at www.saniona.com.