Tesofensine/Metoprolol Tartrate

SAN DIEGO & COPENHAGEN, Denmark--(BUSINESS WIRE)--Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) and Saniona (OMX: SANION) 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. Given the favorable safety and tolerability profile and the prioritization of essential tremor as the lead indication, Acadia Pharmaceuticals and Saniona are seeking regulatory approval to evaluate ACP-711 in elderly healthy volunteers and to test higher repeated doses. To enable this extension, the study has been temporarily paused until regulatory approval. About Acadia Pharmaceuticals Acadia is advancing breakthroughs in neuroscience to elevate life. Since our founding we have been working at the forefront of healthcare to bring vital solutions to people who need them most. We developed and commercialized the first and only FDA-approved drug to treat hallucinations and delusions associated with Parkinson’s disease psychosis and the first and only approved drug in the United States and Canada for the treatment of Rett syndrome. Our clinical-stage development efforts are focused on Prader-Willi syndrome, Alzheimer’s disease psychosis and multiple other programs targeting neuroscience and neuro-rare diseases. For more information, visit us at Acadia.com and follow us on LinkedIn and X. About Saniona Saniona (OMX: SANION) is a clinical-stage biopharmaceutical company leading the way in ion channel modulation for the treatment of neurological disorders. Saniona’s internal pipeline includes SAN2219, targeting acute repetitive seizures; SAN2355, addressing refractory focal onset seizures; and SAN2465, positioned for major depressive disorders. Saniona has two strategic development collaborations. ACP-711 (formerly SAN711) is being prepared for Phase 2 for essential tremor in collaboration with Acadia Pharmaceuticals and tesofensine is out licensed for obesity to Medix, which has submitted a market authorization application (MAA) in Mexico. In addition, Saniona oversees two clinical programs poised for collaboration. Tesomet™ is ready for Phase 2b, targeting rare eating disorders, while SAN903 is ready for Phase 1 for inflammatory bowel disease. Saniona partners include Acadia Pharmaceuticals, Boehringer Ingelheim GmbH, Productos Medix S.A. de S.V., AstronauTx Limited, and Cephagenix ApS. Saniona is based in Copenhagen and listed on Nasdaq Stockholm Main Market. For more information, visit www.saniona.com. Acadia’s Forward-Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and can be identified by terms such as “intends,” “may,” “will,” “should,” “can,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions (including the negative thereof) intended to identify forward-looking statements. Forward-looking statements contained in this press release, include, but are not limited to, statements about: (i) our clinical development plans related to ACP-711 and (ii) the safety profile of ACP-711. Forward-looking statements are subject to known and unknown risks, uncertainties, assumptions, and other factors that may cause our actual results, performance or achievements to differ materially and adversely from those anticipated or implied by our forward-looking statements. Given the risks and uncertainties, you should not place undue reliance on these forward-looking statements. For a discussion of these and other risks, uncertainties, assumptions, and other factors that may cause our actual results, performance or achievements to differ, please refer to our quarterly report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 27, 2025, as well as our subsequent filings with the Securities and Exchange Commission from time to time. The forward-looking statements contained herein are made as of the date hereof, and we undertake no obligation to update them after this date, except as required by law. Saniona’s Forward-Looking Statement This press release contains certain forward-looking information that reflects Saniona’s current views of future events and financial and operational performance. Words such as “intends”, “anticipates”, “expects”, “can”, “plans”, “estimates” and similar expressions regarding indications or forecasts of future developments or trends, and which are not based on historical facts, constitute forward-looking information. Forward-looking information is inherently associated with both known and unknown risks and uncertainties because it is dependent on future events and circumstances. Forward-looking information is not a guarantee of future results or developments and actual results may differ materially from results referred to in forward-looking information. Forward looking information in the report is only applicable on the date of issue of the report. Saniona does not commit to publishing updates or revision of any forward-looking statements as a result of new information, future events or similar circumstances other than those required by applicable legislation.

Saniona (OMX: SANION), a clinical-stage biopharmaceutical company, today announces that it has dosed the first subjects with SAN711 in a Phase 1 multiple ascending dose (MAD)/biomarker study. This marks a significant milestone that put the foundation for launching a clinical proof-of-concept study in children with absence seizures, scheduled for 2025. Topline data from the Phase 1 study is anticipated by the end of 2024. This Phase 1 MAD/biomarker study will investigate three critical aspects to inform future clinical trials: the effect of food intake on SAN711 dosing, the safety and tolerability as well as the potential benefits of higher doses using clinically relevant pharmacodynamic biomarkers. These insights will refine the dosing strategy for future patient studies as the Phase 1 MAD/biomarker study will assess the safety, tolerability, and pharmacokinetics of SAN711 in higher doses than those used in the previous Phase 1 study, while gathering data on food interactions and the drug's pharmacodynamic effects on EEG during both awake and sleep states in healthy volunteers. Saniona’s earlier Phase 1 study demonstrated excellent tolerability and indicated potential therapeutic benefit at relevant clinical plasma concentrations. The current study builds on these findings by exploring whether higher doses can offer even greater potential without compromising safety. Additionally, preclinical data suggests that SAN711 selective pharmacology modulates certain brain circuits, which can be detected via EEG measurements during both awake and sleep states. This not only serves as a functional biomarker of SAN711’s activity in the brain but may also indicate potential benefits for patients in future studies. The study is being conducted in collaboration with Evotec at the Clinical Research Centre (CRC) of the University Hospital in Verona, Italy. Both Evotec and CRC bring extensive expertise in neurological and psychiatric clinical research, which will support the successful execution of the study. About SanionaSaniona (OMX: SANION) is a clinical-stage biopharmaceutical company leading the way in ion channel modulation for the treatment of epilepsy and other neurological disorders. Saniona’s epilepsy pipeline features SAN711, a Phase 2-ready candidate drug targeting absence seizures, SAN2219 for acute repetitive seizures, and SAN2355, addressing refractory focal onset seizures. Beyond epilepsy, Saniona oversees four clinical programs poised for collaboration. Tesofensine, Saniona’s most advanced candidate, is progressing towards regulatory approval for obesity in Mexico through a partnership with Medix. Tesomet™ is ready for Phase 2b, targeting rare eating disorders, while SAN903 is ready for Phase 1 for inflammatory bowel disease and SAN2465 is set for preclinical development for major depressive disorder. Saniona has esteemed partners, including Boehringer Ingelheim GmbH, Productos Medix, S.A de S.V, AstronauTx Limited, and Cephagenix ApS. Saniona is based in Copenhagen and listed on Nasdaq Stockholm Main Market.For more information, please visit www.saniona.com.