Clinical Trials

Date: 2017-12-04

Type of information: Initiation of development program

phase:

Announcement: initiation of development program

Company: Saniona (Denmark)

Product: SAN711

Action mechanism:

GABA receptor modulator. SAN711 is a first-in-class pain and itch-relieving compound, which has the potential of being a first-line treatment option for pain management in patients suffering from untreatable neuropathic pain or itching disorders, either as standalone treatment or as an add-on medication to existing suboptimal therapies. SAN711 acts on the receptors for GABA, the main inhibitory signaling mediator in the nervous system. SAN711 works selectively on receptors containing the GABA-alpha3 proteins without efficacy on the main GABA-A receptors in the brain including the so-called alpha1 protein. This is important, since the sedative and hypnotic adverse effects of current marketed product acting on the receptors of GABA, such as Valium®, are due to its action on the alpha1 containing receptors, whereas the pain killing and anti-itch effects rely on its effects on alpha 3 containing receptors. This means that SAN711 may regulate the body's own pain and itch regulating system in the spinal cord without promoting unwanted side effects through activation of other GABA systems in the brain. The preclinical studies with the compound have confirmed efficacy in animal models of neuropathic pain and itching without the sedative effect.

Disease: neuropathic pain, chronic itching

Therapeutic area:

Country:

Trial details:

Latest news:

• On December 4, 2017, Saniona announced the selection of a preclinical candidate, SAN711, for the treatment of neuropathic pain and chronic itching. The nomination is consistent with Saniona's strategy to progress innovative products from its internal research pipeline towards clinical development prior to partnering.
In May 2016 Saniona announced plans to initiate extended non GLP preclinical studies on backup compounds for its first generation GABAA a2/a3 compound AN363. These preclinical studies led to the selection of the GABAA a2/a3 selective compound SAN711, which has demonstrated desirable efficacy and devoid of undesirable effects observed with its predecessor AN363.
Preclinical development of SAN711 will encompass scale-up of the manufacturing process, GMP production and various toxicology studies, which will form the basis for a regulatory application to initiate first-in-man clinical trials. Saniona is concurrently working with its development partners to initiate Phase 1 clinical trials in the first half of 2019.