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Saniona reports positive top line results from the SAN711 Phase 1 Clinical Trial

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PRESS RELEASE

June 30, 2022

Saniona (OMX: SANION), a clinical stage biopharmaceutical company, today announced that it has successfully completed its Phase 1 clinical trial of SAN711, which is positioned for the treatment of neuropathic pain disorders. Data from the trial demonstrated that SAN711 was safe and well tolerated across all dosing cohorts with a favorable absorption and distribution profile. There were no serious adverse events, and all subjects completed the study. Long term dosing with SAN711 at a well tolerated dose of 0.8 mg twice a day resulted in 24-hour receptor occupancy ranging between 50% and 72% assessed to lead to desired pharmacological effects. The results of this Phase 1 clinical trial open the path for continued clinical development of SAN711.

The Phase 1 clinical trial was conducted in 66 healthy volunteers. The primary objective of the study was to determine the safety and tolerability of SAN711, which was evaluated through single ascending dose and multiple ascending dose phases of the study. The secondary objective was to measure binding to target receptors, which was assessed during a positron emission tomography (PET) evaluation phase of the study. The clinical trial was conducted in the United Kingdom (U.K.) under the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA).

“We are highly encouraged to see that our predictions from preclinical studies are reproduced so nicely in human volunteers”, said Karin Sandager Nielsen, CSO. “As expected SAN711 was very well absorbed, distributed, and tolerated in humans. SAN711 shows clear differentiation in its side effect profile compared to classical, non-selective GABA modulators of the benzodiazepine type such as valium which is dose limited by sedation. Importantly, we have in this study demonstrated that we can safely exceed human exposure levels of SAN711 beyond what is needed to show strong efficacy in our preclinical pain models”.

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