ACP-711 / Saniona, Acadia Pharma - LARVOL DELTA

Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 (formerly SAN711) Phase 1 Study (Businesswire) - "Acadia Pharmaceuticals Inc...and Saniona...today announced the successful completion of the two originally planned cohorts in their Phase 1 multiple-ascending-dose MAD study (EUCT: 2024-514514-12-00) of ACP-711, formerly SAN711, in healthy volunteers. In the study, ACP-711 was safe and generally well tolerated across all dosing cohorts. There were no serious adverse events, and all participants completed the study. Most adverse events were mild. No safety laboratory concerns, cardiovascular concerns, or abnormal neurological findings were observed."

Trial completion date • Migraine • Pain

Selective activation of alpha 3-containing GABA-A receptors blocks absence seizures and increases sleep spindles (Neuroscience 2023) - "In this study, we investigated the effects of SAN711, a selective PAM at alpha 3-containing GABA-ARs, on spontaneous absence seizures in male GAERS rats and sleep spindles in male Wistar rats...These effects might be mediated by alpha 3-containing GABA-ARs in the NRT and/or cortical layer 6 neurons. These results demonstrate for the first time that direct activation of alpha 3-containing GABA-ARs controls spontaneous absence seizures and spindles of natural sleep."

Absence Seizure Disorder • CNS Disorders • Epilepsy

Saniona reports positive top line results from the SAN711 Phase 1 Clinical Trial (GlobeNewswire) - P1 | N=80 | NCT04971135 | Sponsor: Saniona | "Saniona...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..."

P1 data • CNS Disorders • Neuralgia • Pain

Saniona Announces Refocused Strategy on Ion Channel R&D and Restructuring of Board of Directors and Executive Management Team (GlobeNewswire) - "Saniona...today announced that it will refocus its strategy on ion channel research and development (R&D) and, as a result, further streamline its operations....SAN711 positioned for partnering: Over the past two years....The most compelling data obtained thus far indicate substantial potential value for SAN711 in migraine, trigeminal neuralgia and neuropathic pain. As these are larger, non-rare indications, Saniona has decided to actively explore opportunities to out-license SAN711 and generate non-dilutive income."

Licensing / partnership • CNS Disorders • Neuralgia • Pain

Saniona Initiates Positron Emission Tomography (PET) Stage of SAN711 Phase 1 Clinical Trial (GlobeNewswire) - "Saniona...today announced that it has initiated the positron emission tomography (PET) stage of its Phase 1 clinical trial of SAN711....The ongoing Phase 1 trial is placebo-controlled, and the data remain blinded. Saniona continues to expect data from the trial by the end of the first half of 2022."

P1 data • Trial status • CNS Disorders • Neuralgia • Pain

Saniona Initiates Multiple Ascending Dose Stage of SAN711 Phase 1 Clinical Trial (GlobeNewswire) - "Saniona...today provided an update on progress in its Phase 1 clinical trial of SAN711. The company reported that it has now also initiated the multiple ascending dose stage of the trial. The study is placebo-controlled, and the data remain blinded. Saniona continues to expect data from the trial by the end of the first half of 2022."

P1 data • Trial status • CNS Disorders • Neuralgia • Pain

The imidazodiazepine, KRM-II-81: An example of a newly emerging generation of GABAkines for neurological and psychiatric disorders. (PubMed, Pharmacol Biochem Behav) - "Recently, however, there has been a resurgence of efforts to bring GABAkines to patients, the FDA approval of the neuroactive steroid brexanolone for post-partum depression in 2019 being the first. Other neuroactive steroids are in various stages of clinical development (ganaxolone, zuranolone, LYT-300, Sage-324, PRAX 114, and ETX-155). These GABAkines and non-steroid compounds (GRX-917, a TSPO binding site ligand), darigabat (CVL-865), an α2/3/5-preferring GABAkine, SAN711, an α3-preferring GABAkine, and the α2/3-preferring GABAkine, KRM-II-81, bring new therapeutic promise to this highly utilized medicinal target in neurology and psychiatry...KRM-II-81 also produces anxiolytic- and antidepressant-like effects in rodent models. Other key features of the pharmacology of this compound are its low sedation rate, lack of tolerance development, and the ability to prevent the development of seizure sensitization."

Journal • Review • Anesthesia • CNS Disorders • Depression • Epilepsy • Mental Retardation • Neuralgia • Pain • Postpartum Depression • Psychiatry • Vascular Neurology

First-in-human Study of SAN711 in Healthy Participants (clinicaltrials.gov) - P1; N=80; Recruiting; Sponsor: Saniona

Clinical • New P1 trial

"BioStock: Sanionas CMO om den nya kliniska studien med SAN711 https://t.co/nryJU6UkZt" (@CisionNews)

Saniona Initiates Phase 1 Clinical Trial of SAN711 (GlobeNewswire) - "Saniona...announced that it has dosed the first patient in a Phase 1 clinical trial of SAN711...SAN711 is a first-in-class positive allosteric modulator of GABA-A α3 receptors and may be applicable in the treatment of rare neuropathic disorders. Data from the trial are expected in the first half of 2022....The Phase 1 clinical trial will be conducted in approximately 80 healthy volunteers. The primary objective of the study is to determine the tolerability and the maximum tolerated dose of SAN711, which will be evaluated through single ascending dose and multiple ascending dose phases of the study."

Trial status • CNS Disorders • Neuralgia • Pain

[VIRTUAL] SAN711, a selective GABAA 3 receptor positive allosteric modulator as a novel treatment for trigeminal neuralgia (EAN 2021) - "Carbamazepine (30mg/kg, po), the 1st line treatment for trigeminal neuralgia, was used as a reference standard All rats developed ES-induced mechanical and thermal allodynia. These data support the continued development of SAN711 as a novel treatment for trigeminal neuralgia and other facial neuropathic pain disorders"

Neuralgia • Pain • Peripheral Neuropathic Pain

Saniona to Present Preclinical Data on SAN711 at the 7th Congress of the European Academy of Neurology (GlobeNewswire) - "Saniona...today announced it will present preclinical data on SAN711 in a model of facial neuropathic pain at the 7th Congress of the European Academy of Neurology (EAN), which is being held virtually June 19 - 22, 2021...will give an ePresentation titled, 'SAN711, a Selective GABAA α3 Receptor Positive Allosteric Modulator as a Novel Treatment for Trigeminal Neuralgia'...Saniona expects to begin a Phase 1 study of SAN711 in healthy volunteers in mid-2021, with data expected in early 2022."

New P1 trial • P1 data • Preclinical • Neuralgia • Pain