Wednesday, 26 June 2019

Saniona announces succesful completion of preclinical development of SAN711

19 February 2019 | News

SAN711 has the potential to become a novel treatment of severe and untreatable itching conditions caused by renal failure and liver diseases as well as rare neuropathic itching diseases such as Brachioradial pruritus.

Image Credit: Flickr

Image Credit: Flickr

Saniona, a biotech company focused on CNS and eating disorders has announced the successful completion of preclinical development of SAN711, for the treatment of chronic itching and neuropathic pain. Preparations for Phase 1 clinical trials are underway and scheduled to start during summer 2019.

“Preclinical data for SAN711 are very compelling and we believe it has the potential to become a first-line treatment in patients suffering from severe untreatable itching conditions and neuropathic pain disorders. There is a significant unmet medical need and a significant commercial opportunity in rare itching disorders for which we may potentially pursue accelerated development, for example in Brachioradial pruritus,” said Jørgen Drejer, CEO of Saniona.

SAN711 is a selective GABAA α3 modulator (PAM) which has demonstrated strong efficacy in rodent itching and pain models. The company has completed a comprehensive preclinical package, including full toxicology and GMP validation. The clinical candidate now is ready for filing for clinical testing. SAN711 comes from Saniona’s advanced ion channel platform. Phase 1 clinical testing is scheduled to start over the summer 2019, either internally or together with a potential partner.

SAN711 has the potential to become a novel treatment of severe and untreatable itching conditions caused by renal failure and liver diseases as well as rare neuropathic itching diseases such as Brachioradial pruritus. Many chronic itching conditions are not related to skin reactions but are a result of chronic changes in sensory modulation in the spinal cord, mediated by GABAA α3 receptors, which SAN711 targets. SAN711 has proven to be effective in relevant itching models and recent peer-reviewed literaturei in the field provides a strong scientific rationale for developing SAN711 for itching.

SAN711 also has the potential to become a novel and revolutionizing non-narcotic treatment concept for chronic pain conditions such as neuropathic pain, which has proven to be notoriously difficult to manage. It is estimated that 40-60% of patients do not respond to existing drugs and that the responders only achieve partial pain relief.

Narcotic analgesics such as morphine are effective for acute treatment of neuropathic pain, but patients need higher and higher doses to maintain pain relief due to tolerance development. In addition, the abuse potential of narcotic analgesics has proven to be a major problem for treatment of chronic neuropathic pain. As opposed to morphine, the effect of SAN711 is maintained after chronic treatment in neuropathic pain models. Moreover, SAN711 appears to be very well tolerated without abuse liability and other side effects such as drowsiness, dizziness and somnolence seen with strong analgesic.

Saniona is a research and development company focused on drugs for diseases of the central nervous system and eating disorders. The company has four programs in clinical development. Saniona intends to develop and commercialize treatments for orphan indications such as Prader-Willi syndrome and hypothalamic obesity on its own. The research is focused on ion channels and the company has a broad portfolio of research programs. Saniona has partnerships with Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V and Cadent Therapeutics. Saniona is based in Copenhagen, Denmark, and the company’s shares are listed at Nasdaq Stockholm Small Cap.

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