Acadia Pharmaceuticals and Saniona Announce Initial Positive Results from ACP-711 (formerly SAN711) Phase 1 Study
Acadia Pharmaceuticals (ACAD) and Saniona have announced positive results from their Phase 1 multiple-ascending-dose (MAD) study of ACP-711 in healthy volunteers. The study demonstrated that ACP-711 was safe and well-tolerated across all dosing cohorts, with no serious adverse events reported.
Key findings include:
- All participants completed the study
- Most adverse events were mild
- No safety laboratory concerns
- No cardiovascular concerns
- No abnormal neurological findings
Given these favorable results and the prioritization of essential tremor as the lead indication, the companies are seeking regulatory approval to evaluate ACP-711 in elderly healthy volunteers and test higher repeated doses. The study has been temporarily paused pending this regulatory approval.
Acadia Pharmaceuticals (ACAD) e Saniona hanno annunciato risultati positivi dal loro studio di Fase 1 a dosi multiple ascendenti (MAD) di ACP-711 su volontari sani. Lo studio ha dimostrato che ACP-711 è stato sicuro e ben tollerato in tutti i gruppi di dosaggio, senza eventi avversi gravi riportati.
I principali risultati includono:
- Tutti i partecipanti hanno completato lo studio
- La maggior parte degli eventi avversi è stata lieve
- Nessuna preoccupazione di laboratorio sulla sicurezza
- Nessuna preoccupazione cardiovascolare
- Nessun riscontro neurologico anomalo
Data la favorevole situazione e la priorità del tremore essenziale come indicazione principale, le aziende stanno cercando l'approvazione regolatoria per valutare ACP-711 in volontari sani anziani e testare dosi ripetute più elevate. Lo studio è stato temporaneamente sospeso in attesa di questa approvazione regolatoria.
Acadia Pharmaceuticals (ACAD) y Saniona han anunciado resultados positivos de su estudio de Fase 1 de dosis múltiples ascendentes (MAD) de ACP-711 en voluntarios sanos. El estudio demostró que ACP-711 fue seguro y bien tolerado en todos los grupos de dosis, sin eventos adversos graves reportados.
Los hallazgos clave incluyen:
- Todos los participantes completaron el estudio
- La mayoría de los eventos adversos fueron leves
- No hubo preocupaciones de laboratorio sobre la seguridad
- No hubo preocupaciones cardiovasculares
- No se encontraron hallazgos neurológicos anormales
Dado estos resultados favorables y la priorización del temblor esencial como indicación principal, las empresas están buscando la aprobación regulatoria para evaluar ACP-711 en voluntarios sanos mayores y probar dosis repetidas más altas. El estudio se ha pausado temporalmente a la espera de esta aprobación regulatoria.
아카디아 제약 (ACAD)와 사니오나는 건강한 자원봉사자를 대상으로 한 ACP-711의 1상 다중 상승 용량 (MAD) 연구에서 긍정적인 결과를 발표했습니다. 이 연구는 ACP-711이 모든 용량 그룹에서 안전하고 잘 견뎌졌으며, 심각한 부작용이 보고되지 않았음을 보여주었습니다.
주요 발견 사항은 다음과 같습니다:
- 모든 참가자가 연구를 완료했습니다
- 대부분의 부작용은 경미했습니다
- 안전성에 대한 실험실 우려 없음
- 심혈관 우려 없음
- 비정상적인 신경학적 발견 없음
이러한 유리한 결과와 필수 떨림을 주요 적응증으로 우선시함에 따라, 회사들은 ACP-711을 건강한 노인 자원봉사자에서 평가하고 더 높은 반복 용량을 시험하기 위해 규제 승인을 요청하고 있습니다. 이 연구는 이 규제 승인을 기다리는 동안 일시적으로 중단되었습니다.
Acadia Pharmaceuticals (ACAD) et Saniona ont annoncé des résultats positifs de leur étude de Phase 1 à doses multiples ascendantes (MAD) de ACP-711 chez des volontaires sains. L'étude a démontré qu'ACP-711 était sûr et bien toléré dans tous les groupes de dosage, sans événements indésirables graves rapportés.
Les principales conclusions incluent:
- Tous les participants ont terminé l'étude
- La plupart des événements indésirables étaient légers
- Aucune préoccupation de laboratoire concernant la sécurité
- Aucune préoccupation cardiovasculaire
- Aucune constatation neurologique anormale
Étant donné ces résultats favorables et la priorité du tremblement essentiel en tant qu'indication principale, les entreprises recherchent une approbation réglementaire pour évaluer ACP-711 chez des volontaires sains âgés et tester des doses répétées plus élevées. L'étude a été temporairement suspendue en attendant cette approbation réglementaire.
Acadia Pharmaceuticals (ACAD) und Saniona haben positive Ergebnisse aus ihrer Phase-1-Studie mit mehrfach steigenden Dosen (MAD) von ACP-711 bei gesunden Probanden bekannt gegeben. Die Studie zeigte, dass ACP-711 in allen Dosierungsgruppen sicher und gut verträglich war, ohne dass schwerwiegende unerwünschte Ereignisse berichtet wurden.
Wichtige Erkenntnisse sind:
- Alle Teilnehmer haben die Studie abgeschlossen
- Die meisten unerwünschten Ereignisse waren mild
- Keine Sicherheitsbedenken im Labor
- Keine kardiovaskulären Bedenken
- Keine abnormalen neurologischen Befunde
Angesichts dieser positiven Ergebnisse und der Priorisierung des essentiellen Tremors als Hauptindikation streben die Unternehmen eine behördliche Genehmigung an, um ACP-711 bei gesunden älteren Probanden zu bewerten und höhere wiederholte Dosen zu testen. Die Studie wurde vorübergehend ausgesetzt, bis diese behördliche Genehmigung vorliegt.
- Phase 1 trial met safety endpoints
- No serious adverse events reported
- All participants completed the study
- Clear pathway to Phase 2 for essential tremor indication
- Temporary trial pause pending regulatory approval
- Additional regulatory approval needed for dose escalation
Insights
Acadia Pharmaceuticals and Saniona have reported positive Phase 1 safety results for ACP-711 in their clinical development program. The multiple-ascending-dose study demonstrated the drug was safe and well-tolerated with no serious adverse events and mostly mild side effects.
This announcement represents a critical early milestone in the ACP-711 development program, which has now been designated for essential tremor as its lead indication. Essential tremor affects approximately 7 million Americans, with effective treatment options currently available.
The favorable safety profile has prompted the companies to seek regulatory approval for expanding the study to include elderly subjects and higher doses - both important steps in neurological drug development. The temporary study pause is a standard procedure when amending clinical protocols.
For context, Phase 1 studies primarily evaluate safety rather than efficacy. While these results reduce early clinical risk, ACP-711 still faces significant development hurdles, including demonstrating efficacy in Phase 2 trials before advancing to pivotal studies.
This collaboration highlights Acadia's focus on neuroscience and neuro-rare diseases alongside Saniona's expertise in ion channel modulation. Ion channels represent promising drug targets for neurological disorders like essential tremor where abnormal neuronal signaling drives symptoms.
The successful Phase 1 results for ACP-711 represent a de-risking event in Acadia and Saniona's joint development program, albeit at an early stage. While positive safety data is necessary, it's only the first hurdle in CNS drug development, where failure rates remain among the highest across therapeutic areas.
The selection of essential tremor as the lead indication creates a clear development pathway. This strategic choice targets a condition with substantial unmet need where current treatments (primarily off-label beta-blockers and anti-seizure medications) offer suboptimal efficacy and tolerability.
The decision to extend testing to elderly populations is particularly relevant for essential tremor, which affects approximately 4% of adults over 40 and increases in prevalence with age. Establishing safety in older subjects will be critical for the target demographic.
For Saniona, this partnership represents significant validation of their ion channel platform technology. As the smaller partner, positive advancement of this asset carries proportionally greater impact on their pipeline value.
For Acadia, ACP-711 complements their commercial CNS portfolio and aligns with their strategy of building depth in neuroscience. The company continues leveraging its commercial infrastructure and regulatory expertise in neurological disorders following previous FDA approvals.
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
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
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.
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Acadia Investor and Media Contacts:
Acadia Pharmaceuticals Inc.
Al Kildani
(858) 261-2872
ir@acadia-pharm.com
Acadia Pharmaceuticals Inc.
Deb Kazenelson
(818) 395-3043
media@acadia-pharm.com
Saniona AB (publ)
Thomas Feldthus
+45 2210 9957
Thomas.feldthus@saniona.com
Source: Acadia Pharmaceuticals Inc.
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