Supernus Announces Promising Data from Open-Label Phase 2a Study of SPN-820 in Adults with Major Depressive Disorder
Supernus Pharmaceuticals (Nasdaq: SUPN) announced promising data from its open-label Phase 2a study of SPN-820 in adults with major depressive disorder. The study demonstrated a rapid and substantial decrease in depressive symptoms, with clinically meaningful improvements observed in both HAM-D6 and MADRS scores. Key findings include:
- Improvement of -6.1 at two hours and -9.6 at Day 10 on HAM-D6 total score
- Improvement of -16.6 at four hours and -22.9 at Day 10 on MADRS total score
- 80% decrease in suicidal ideation
- Well-tolerated with few adverse events
SPN-820, a novel intracellular modulator of mTORC1, shows potential as a treatment option for depression. Supernus expects to complete enrollment in the Phase 2b randomized double-blind placebo-controlled study in November, with topline results anticipated in the first half of 2025.
Supernus Pharmaceuticals (Nasdaq: SUPN) ha annunciato dati promettenti dal suo studio open-label di Fase 2a su SPN-820 in adulti con disturbo depressivo maggiore. Lo studio ha dimostrato una riduzione rapida e significativa dei sintomi depressivi, con miglioramenti clinicamente significativi osservati sia nei punteggi HAM-D6 che MADRS. I principali risultati includono:
- Miglioramento di -6.1 a due ore e -9.6 al giorno 10 nel punteggio totale HAM-D6
- Miglioramento di -16.6 a quattro ore e -22.9 al giorno 10 nel punteggio totale MADRS
- Riduzione dell'80% dell'ideazione suicidaria
- Ben tollerato con pochi eventi avversi
SPN-820, un nuovo modulatore intracellulare dell'mTORC1, mostra potenziale come opzione terapeutica per la depressione. Supernus prevede di completare l'arruolamento nello studio randomizzato, in doppio cieco e controllato con placebo di Fase 2b a novembre, con risultati preliminari attesi nella prima metà del 2025.
Supernus Pharmaceuticals (Nasdaq: SUPN) anunció datos prometedores de su estudio abierto de Fase 2a de SPN-820 en adultos con trastorno depresivo mayor. El estudio demostró una reducción rápida y significativa de los síntomas depresivos, con mejoras clínicamente significativas observadas en las puntuaciones de HAM-D6 y MADRS. Los hallazgos clave incluyen:
- Mejora de -6.1 a las dos horas y -9.6 en el Día 10 en la puntuación total de HAM-D6
- Mejora de -16.6 a las cuatro horas y -22.9 en el Día 10 en la puntuación total de MADRS
- Reducción del 80% en la ideación suicida
- Bien tolerado con pocos eventos adversos
SPN-820, un novedoso modulador intracelular de mTORC1, muestra potencial como opción de tratamiento para la depresión. Supernus espera completar la inclusión en el estudio aleatorizado, doble ciego y controlado con placebo de Fase 2b en noviembre, con resultados preliminares anticipados en la primera mitad de 2025.
슈퍼너스 제약(Supernus Pharmaceuticals, Nasdaq: SUPN)은 주요 우울장애를 앓고 있는 성인을 대상으로 한 SPN-820의 오픈 라벨 2a 임상 시험에서 유망한 데이터를 발표했습니다. 이 연구는 우울 증상의 빠르고 상당한 감소를 보여주었으며, HAM-D6 및 MADRS 점수에서 임상적으로 의미 있는 개선이 관찰되었습니다. 주요 결과는 다음과 같습니다:
- HAM-D6 총점에서 2시간에 -6.1, 10일에 -9.6 개선
- MADRS 총점에서 4시간에 -16.6, 10일에 -22.9 개선
- 자살 생각 80% 감소
- 몇 가지 부작용을 동반한 잘 견딤
SPN-820은 mTORC1의 새로운 세포 내 조절제로서 우울증 치료 옵션으로서의 가능성을 보여줍니다. 슈퍼너스는 11월에 이중맹검, 위약대조, 무작위화된 2b 단계 연구에 대한 등록을 완료할 것으로 예상하며, 2025년 첫 반기 내에 결과를 기대하고 있습니다.
Supernus Pharmaceuticals (Nasdaq: SUPN) a annoncé des données prometteuses provenant de son étude ouverte de Phase 2a sur SPN-820 chez des adultes atteints de troubles dépressifs majeurs. L'étude a montré une diminution rapide et substantielle des symptômes dépressifs, avec des améliorations cliniquement significatives observées dans les scores HAM-D6 et MADRS. Les principales conclusions incluent :
- Amélioration de -6.1 à deux heures et -9.6 au jour 10 dans le score total HAM-D6
- Amélioration de -16.6 à quatre heures et -22.9 au jour 10 dans le score total MADRS
- Diminution de 80% des idées suicidaires
- Bien toléré avec peu d'événements indésirables
SPN-820, un nouveau modulateur intracellulaire de l'mTORC1, montre un potentiel en tant qu'option de traitement pour la dépression. Supernus prévoit de terminer le recrutement dans l'étude multicentrique randomisée en double aveugle contrôlée par placebo de Phase 2b en novembre, avec des résultats préliminaires attendus dans la première moitié de 2025.
Supernus Pharmaceuticals (Nasdaq: SUPN) hat vielversprechende Daten aus seiner offenen Phase-2a-Studie zu SPN-820 bei Erwachsenen mit majorer depressiver Störung veröffentlicht. Die Studie zeigte eine schnelle und erhebliche Verringerung der depressiven Symptome, wobei klinisch signifikante Verbesserungen in den HAM-D6- und MADRS-Werten beobachtet wurden. Zu den Schlüsselergebnissen gehören:
- Verbesserung um -6,1 nach zwei Stunden und -9,6 am Tag 10 im Gesamtwert von HAM-D6
- Verbesserung um -16,6 nach vier Stunden und -22,9 am Tag 10 im Gesamtwert von MADRS
- 80% Rückgang der Suizidgedanken
- Gut verträglich mit wenigen unerwünschten Ereignissen
SPN-820, ein neuartiger intrazellulärer Modulator von mTORC1, zeigt Potenzial als Behandlungsoption für Depressionen. Supernus erwartet, die Rekrutierung in der randomisierten, doppelblinden, placebokontrollierten Phase-2b-Studie im November abzuschließen, wobei die vorläufigen Ergebnisse in der ersten Hälfte von 2025 erwartet werden.
- Rapid and substantial decrease in depressive symptoms observed
- Clinically meaningful improvements in HAM-D6 and MADRS scores
- 80% reduction in suicidal ideation
- SPN-820 well-tolerated with few adverse events
- Low discontinuation rate of 2.5% due to adverse events
- Phase 2b study enrollment expected to complete in November 2024
- Most common adverse events included headache, nausea, somnolence, and dizziness
- Additional adverse events such as cognitive disorder, dry mouth, fatigue, nasal decongestion, and paresthesia oral were observed
Insights
The Phase 2a study results for SPN-820 are promising for Supernus Pharmaceuticals. The rapid and substantial decrease in depressive symptoms, as measured by HAM-D6 and MADRS scales, is particularly noteworthy. A
The drug's novel mechanism as an mTORC1 modulator sets it apart from current antidepressants. If these results are replicated in larger trials, SPN-820 could potentially address the unmet need for faster-acting antidepressants with a different side effect profile compared to existing options.
However, it's important to note that this was an open-label study without a placebo control, which limits the interpretation of efficacy. The upcoming Phase 2b randomized, double-blind, placebo-controlled study will be important in validating these findings and determining the true clinical potential of SPN-820.
The rapid onset of action observed with SPN-820 is particularly intriguing from a clinical perspective. Current antidepressants typically take weeks to show significant effects, leaving patients vulnerable during this period. A treatment that can provide substantial symptom relief within hours to days could be transformative for acute management of depression.
The tolerability profile appears favorable, with a low discontinuation rate due to adverse events. However, the cognitive disorder side effect warrants further investigation, as cognitive function is important for overall functioning in depression patients.
The reduction in suicidal ideation is a standout finding, as this is a critical aspect of depression management. If confirmed in larger studies, this could position SPN-820 as a valuable option for patients at high risk of suicidal behavior.
While these results are encouraging, we must remain cautious until we see results from the placebo-controlled Phase 2b study, which will provide more definitive evidence of efficacy and safety.
Phase 2a study demonstrated rapid and substantial decrease in depressive symptoms
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
Company to host webcast today at 4:30 p.m. ET to discuss the topline data
Topline results from Phase 2b randomized double-blind placebo-controlled study of SPN-820 in adults with treatment-resistant depression expected first-half 2025
ROCKVILLE, Md., Oct. 17, 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, today announced data from its exploratory open-label Phase 2a clinical study of SPN-820 in adults with major depressive disorder. The study examined the safety and tolerability of SPN-820 2400 mg given once every 3 days as an adjunctive treatment to the current baseline antidepressant therapy, as well as assessed the rapid onset of improvement in depressive symptoms. The analysis is based on 40 enrolled subjects, of which 38 completed the 10-day treatment period.
Summary of the Data
- 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) total score.
- Clinically meaningful improvement of –16.6 at four hours and –22.9 at Day 10 on the Montgomery Åsberg Depression Rating Scale (MADRS) total score.
- Suicidal ideation decreased by
80% (12.5% with suicidal ideation at baseline decreased to2.6% with suicidal ideation at Day 10). - SPN-820 was well-tolerated with few adverse events (AEs) and had acceptable tolerability with a discontinuation rate of
2.5% due to AEs. - Most common AEs related to the drug included headache, nausea, somnolence, and dizziness. Additional AEs such as cognitive disorder, dry mouth, fatigue, nasal decongestion, and paresthesia oral were observed.
“These Phase 2a data underscore our belief that SPN-820 has the potential as a novel treatment option for patients with depression, with the opportunity to decrease symptoms quickly and without certain burdensome side effects,” said Jack Khattar, President and CEO of Supernus. “We expect to complete enrollment in the Phase 2b randomized double-blind placebo-controlled study of SPN-820 in adults with treatment-resistant depression in November of this year, with topline results expected in the first half of 2025.”
Webcast Details
Supernus will host a conference call and webcast today, October 17, 2024, at 4:30 p.m. ET to discuss these topline results. A live webcast with presentation slides will be available via this webcast link or in the Events & Presentations section of the Company’s Investor Relations website at www.supernus.com/Investors. Following management’s prepared remarks and discussion of the interim trial results, the call will open for questions.
Participants may also pre-register any time before the call here. Once registration is completed, participants will be provided a dial-in number with a personalized conference code to access the call. Please dial in 15 minutes prior to the start time.
Following the live call, a replay will be available on the Company's Investor Relations website at www.supernus.com/Investors. The webcast will be available on the Company’s website for 60 days following the live call.
About SPN-820
SPN-820 is a first-in-class, orally active small molecule that increases the brain mechanistic target of rapamycin complex 1 (mTORC1) mediated synaptic function intracellularly. 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 potential 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 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 Westwicke
(443) 213-0505
peter.vozzo@westwicke.com
FAQ
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