Saniona initiates extended preclinical research studies on backup compound to AN363; AN363 is put on hold

Saniona, a leading biotech company in the field of ion channels, today announces that it plans to initiate extended non GLP preclinical studies on a backup compound to AN363. Saniona will at the same time put the ongoing investigations on the AN363 compound on hold.

“We remain highly enthusiastic about the concept of using GABAA α2, α3 subtype specific compounds for chronic pain. The toxicology finding with AN363 at high doses in rats has not been reported in animal or human studies with other compounds with a similar pharmacology profile including the close analogue AN721. We therefore have good reasons to believe that the unexplained findings with AN363 is not a class effect,” says Jørgen Drejer, CEO of Saniona.

Saniona has finalized the preclinical toxicology studies for AN363. In September 2015, Saniona announced that it has decided to further investigate one of the specific findings in rats, which occurred at higher doses. This finding was not observed in dogs even at the maximum dose.

Although the data supports that AN363 could be given safely to humans in single doses, Saniona is concerned about using AN363 in multiple doses for chronic pain in humans without having a clear understanding of the observed finding in rats. During the last seven months, Saniona has performed a number of additional investigations together with international recognised experts in the field without coming to any firm explanation of the findings. Rather than continuing this expensive and time consuming process without any guarantee for success, Saniona has concluded that a more constructive path forward is to focus on another compound from the broad preclinical program. Saniona has now decided to initiate extended non GLP preclinical studies on a backup compound to AN363 with the aim to bring this compound forward towards clinical development. As a consequence, AN363 development is put on hold.

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 Upsher-Smith Laboratories, Inc., Productos Medix, S.A de S.V and Saniona’s Boston based spinout Ataxion Inc., which is financed by Atlas Venture Inc. and Biogen Inc. Saniona is based in Copenhagen, Denmark, where it has a research center of high international standard. Saniona is listed at AktieTorget since April 2014 and has about 3,000 shareholders. The company’s share is traded under the ticker SANION. Read more at www.saniona.com.

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