Saniona selects preclinical candidate

COPENHAGEN, Denmark—Saniona, a biotech company in the field of ion channels, announced toward the end of 2017 the selection of a preclinical candidate, SAN711, for the treatment of neuropathic pain and chronic itching.

“The selection of SAN711 is a significant milestone for Saniona that further demonstrates the robustness of our unique ion channel platform,” said Jørgen Drejer, CEO of Saniona. “SAN711 has the potential to become a first-line treatment for pain management in patients suffering from untreatable neuropathic pain disorders. We have also established in preclinical studies that SAN711 could be used to treat itching, a severely disabling consequence of certain skin disorders, including atopic dermatitis and psoriasis.”

In May 2016, Saniona announced plans to initiate extended non-GLP preclinical studies on backup compounds for its first-generation GABAA α2/α3 compound AN363. These preclinical studies led to the selection of the GABAA α2/α3 selective compound SAN711, which has demonstrated desirable efficacy and is 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-human clinical trials. Saniona is concurrently working with its development partners to initiate Phase 1 clinical trials in the first half of 2019.

Drejer concluded, “We are enthusiastic about the opportunity to use GABAA α3 subtype specific compounds for chronic pain and itching and are eager to progress SAN711 towards the clinic. In animal models, SAN711 has shown efficacy for neuropathic pain and itching. These models have also shown that SAN711 is well tolerated with no signs of sedation or other undesirable characteristics associated with other non-selective GABA modulators.”

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 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 products 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.