Supernus Presents Promising Data from Open-Label Phase 2a Study of SPN-820 Data in Major Depressive Disorder at Psych Congress 2024
Supernus Pharmaceuticals (SUPN) presented promising Phase 2a study results for SPN-820 in treating Major Depressive Disorder at Psych Congress 2024. The study, involving 40 participants, demonstrated significant improvements in depressive symptoms. Key findings include a rapid MADRS response rate reaching 84.2% by Day 10, an 80% decrease in suicidal ideation, and clinically meaningful improvements in HAM-D6 and MADRS scores. The drug was well-tolerated with mostly mild to moderate side effects, showing potential as a first-in-class, oral treatment for depression with rapid-acting properties.
Supernus Pharmaceuticals (SUPN) ha presentato risultati promettenti dello studio di Fase 2a per SPN-820 nel trattamento del Disturbo Depressivo Maggiore al Psych Congress 2024. Lo studio, che ha coinvolto 40 partecipanti, ha dimostrato significativi miglioramenti nei sintomi depressivi. Tra i risultati principali, si segnala un tasso di risposta MADRS rapido che ha raggiunto l'84,2% entro il decimo giorno, una diminuzione dell'80% del pensiero suicidario e miglioramenti clinicamente significativi nei punteggi HAM-D6 e MADRS. Il farmaco è stato ben tollerato, presentando per lo più effetti collaterali lievi o moderati, mostrando potenziale come trattamento orale di prima classe per la depressione con proprietà ad azione rapida.
Supernus Pharmaceuticals (SUPN) presentó resultados prometedores del estudio de Fase 2a para SPN-820 en el tratamiento del Trastorno Depresivo Mayor en el Psych Congress 2024. El estudio, que involucró a 40 participantes, demostró mejoras significativas en los síntomas depresivos. Los hallazgos clave incluyen una rápida tasa de respuesta MADRS del 84.2% para el día 10, una disminución del 80% en la ideación suicida y mejoras clínicamente significativas en los puntajes de HAM-D6 y MADRS. El fármaco fue bien tolerado, con efectos secundarios mayormente leves a moderados, mostrando potencial como un tratamiento oral de primera clase para la depresión con propiedades de acción rápida.
Supernus Pharmaceuticals (SUPN)는 Psych Congress 2024에서 SPN-820의 주요 우울 장애 치료를 위한 2a 단계 연구 결과를 발표했습니다. 40명의 참가자가 포함된 이번 연구는 우울증 증상의 유의미한 개선을 보여주었습니다. 주요 발견으로는 10일 차에 MADRS 반응률이 84.2%에 이르렀고, 자살 사상은 80% 감소했으며 HAM-D6 및 MADRS 점수에서 임상적으로 의미 있는 개선이 있었습니다. 이 약물은 대부분 경증에서 중등도의 부작용을 동반하며 잘 견디는 것으로 나타났으며, 신속하게 작용하는 특성을 가진 1세대 경구 우울증 치료제로서의 잠재성을 보여주었습니다.
Supernus Pharmaceuticals (SUPN) a présenté des résultats prometteurs d'une étude de Phase 2a pour SPN-820 dans le traitement du Trouble Dépressif Majeur lors du Psych Congress 2024. L'étude, impliquant 40 participants, a montré des améliorations significatives des symptômes dépressifs. Les résultats clés comprennent un taux de réponse MADRS rapide atteignant 84,2 % au jour 10, une diminution de 80 % des idées suicidaires et des améliorations cliniquement significatives des scores HAM-D6 et MADRS. Le médicament a été bien toléré, avec principalement des effets secondaires légers à modérés, montrant un potentiel en tant que traitement oral de première classe pour la dépression avec des propriétés à action rapide.
Supernus Pharmaceuticals (SUPN) hat vielversprechende Ergebnisse aus der Phase 2a-Studie zu SPN-820 zur Behandlung der Major Depression beim Psych Congress 2024 vorgestellt. Die Studie, an der 40 Teilnehmer teilnahmen, zeigte signifikante Verbesserungen der depressiven Symptome. Zu den wichtigsten Ergebnissen gehören eine schnelle MADRS-Reaktionsrate von 84,2% bis Tag 10, eine Reduktion der Suizidgedanken um 80% und klinisch bedeutende Verbesserungen der HAM-D6- und MADRS-Werte. Das Medikament wurde gut vertragen, mit überwiegend milden bis moderaten Nebenwirkungen und zeigt Potenzial als erste orale Behandlung der Depression mit schnell einsetzenden Eigenschaften.
- Rapid MADRS response rate of 84.2% and remission rate of 63.2% by Day 10
- 80% reduction in suicidal ideation (from 12.5% to 2.6%)
- Significant clinical improvements in HAM-D6 (-9.6) and MADRS (-22.9) scores
- Low discontinuation rate due to adverse events (2.5%)
- Well-tolerated safety profile with no severe or serious adverse events
- Relatively small study size of 40 participants
- Short study duration of only 10 days
Insights
The Phase 2a trial results for SPN-820 show remarkable promise in treating Major Depressive Disorder. Key findings include rapid onset of action with significant improvements in depression scores:
- HAM-D6 score improvements of
-6.1% at 2 hours and-9.6% at Day 10 - MADRS score improvements of
-16.6% at 4 hours and-22.9% at Day 10 - Impressive
84.2% response rate and63.2% remission rate by Day 10
The
Participants in the Phase 2a study experienced rapid and meaningful decreases in depressive symptoms
Suicidal ideation decreased by
SPN-820 was well-tolerated with few adverse events
SPN-820 is a novel, first-in-class intracellular modulator of mTORC1 for the treatment of depression
ROCKVILLE, Md., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, announced data in a poster presentation at Psych Congress 2024 with new data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder (MDD). The study examined the safety and tolerability of 2400 mg of SPN-820 given once every three days as an adjunctive treatment to the current baseline antidepressant therapy and assessed the rapid onset of improvement in depressive symptoms. The study included 40 enrolled subjects, of which 38 completed the 10-day treatment period.
In the Phase 2a study, SPN-820 demonstrated a clinically meaningful improvement of -6.1 at two hours and -9.6 at Day 10 on the Hamilton Depression Rating Scale-6 items (HAM-D6), as well as a clinically meaningful improvement of -16.6 at four hours and -22.9 at Day 10 on the Montgomery Åsberg Depression Rating Scale (MADRS).
New data from the Phase 2a study presented at Psych Congress 2024 demonstrate a rapid MADRS response rate (≥
Suicidal ideation decreased by
“The data shared at the Psych Congress suggest the promise of SPN-820 as a potential first-in-class, novel treatment option for patients with depression, in which it demonstrated rapid acting antidepressant properties, a favorable tolerability profile and convenient, oral at home administration,” said Jonathan Rubin, M.D., Chief Medical Officer and Senior Vice President, Research & Development, Supernus Pharmaceuticals. “By decreasing symptoms safely and effectively without certain burdensome side effects, with a majority of patients reaching a remission threshold in just 10 days, SPN-820 exhibited meaningful improvements on the main depression rating scales, and we remain very excited about its potential to make a difference in the lives of those suffering from depression.”
About SPN-820
SPN-820 is a first-in-class, orally active small molecule that modulates the brain mechanistic target of rapamycin complex 1 (mTORC1), increasing synaptic function via an intracellular mechanism. SPN-820 is being developed to provide a rapid-onset antidepressant response via oral administration for adult patients with depression. The compound has a novel mechanism of action that enhances synaptic activity and cellular metabolism in the brain and has demonstrated a rapid onset of action (signal at two hours) in early clinical studies. SPN-820 is expected to provide rapid antidepressant efficacy without dissociative side effects. A Phase 2b clinical study of SPN-820 in approximately 227 adult patients with treatment-resistant depression is ongoing.
About the SPN-820 Phase 2a Clinical Study
The study is a Phase 2a open-label study in 40 subjects with major depressive disorder (MDD). The primary objective of the study is to assess efficacy in MDD, as well as onset of efficacy and safety.
About Supernus Pharmaceuticals, Inc.
Supernus Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases.
Our diverse neuroscience portfolio includes approved treatments for epilepsy, migraine, ADHD, hypomobility in Parkinson’s disease (PD), cervical dystonia, chronic sialorrhea, and dyskinesia in PD patients receiving levodopa-based therapy. We are developing a broad range of novel, first in class CNS product candidates including new potential treatments for hypomobility in PD, epilepsy, depression, and other CNS disorders.
For more information, please visit www.supernus.com.
Forward Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements do not convey historical information but relate to predicted or potential future events that are based upon management's current expectations. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In addition to the factors mentioned in this press release, such risks and uncertainties include, but are not limited to, the Company’s reporting on preliminary and exploratory open label clinical study on SPN-820, the Company’s ability to sustain and increase its profitability; the Company’s ability to raise sufficient capital to fully implement its corporate strategy; the implementation of the Company’s corporate strategy; the Company’s future financial performance and projected expenditures; the Company’s ability to increase the number of prescriptions written for each of its products and the products of its subsidiaries; the Company’s ability to increase net revenue; the Company’s ability to commercialize its products and the products of its subsidiaries; the Company’s ability to enter into future collaborations with pharmaceutical companies and academic institutions or to obtain funding from government agencies; the Company’s ability to conduct and progress product research and development activities, including the timing and progress of the Company’s clinical trials, and projected expenditures; the Company’s ability to receive, and the timing of any receipt of, regulatory approvals to develop and commercialize the Company’s product candidates including SPN-820; the Company’s ability to protect its intellectual property and the intellectual property of its subsidiaries and operate its business without infringing upon the intellectual property rights of others; the Company’s expectations regarding federal, state and foreign regulatory requirements; the therapeutic benefits, effectiveness and safety of the Company’s product candidates including SPN-820; the accuracy of the Company’s estimates of the size and characteristics of the markets that may be addressed by its product candidates; the Company’s ability to increase its manufacturing capabilities for its products and product candidates including SPN-820; the Company’s projected markets and growth in markets; the Company’s product formulations and patient needs and potential funding sources; the Company’s staffing needs; and other risk factors set forth from time to time in the Company’s filings with the Securities and Exchange Commission made pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.
CONTACTS:
Jack A. Khattar, President and CEO
Timothy C. Dec, Senior Vice President and CFO
Supernus Pharmaceuticals, Inc.
(301) 838-2591
Or
INVESTOR CONTACT:
Peter Vozzo
ICR Healthcare
(443) 213-0505
Peter.Vozzo@westwicke.com
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