Marvel Announces First of Two Final Data Sets from Rett Syndrome Study: MB-204 Significantly Outperforms Trofinetide
Marvel Biosciences (TSXV: MRVL, OTCQB: MBCOF) has released partial final data from its preclinical Rett syndrome study comparing its lead compound MB-204 with Trofinetide, the only FDA and Health Canada approved treatment for the condition.
The study, conducted with the iBraiN Institute, demonstrated that MB-204 (10 mg/kg oral daily) significantly outperformed Trofinetide (100 mg/kg injected daily) across multiple endpoints in Mecp2 mice over a two-week treatment period:
- MB-204 reversed social behavioral deficiencies in nose and paw touching (p<0.0001 vs control)
- MB-204 reversed impairments in following behaviour (p<0.0001 vs control)
- Both treatments improved social preference behaviour in the three-chamber test
- MB-204 reversed spontaneous alternations and same arm returns in Y-maze test (p<0.0001 vs control)
Analysis of the carry-over effects is ongoing and will be released separately. The company plans to publish and present the data at an upcoming scientific conference.
Marvel Biosciences (TSXV: MRVL, OTCQB: MBCOF) ha rilasciato dati parziali finali dal suo studio preclinico sulla sindrome di Rett, confrontando il suo composto principale MB-204 con Trofinetide, l'unico trattamento approvato dalla FDA e da Health Canada per questa condizione.
Lo studio, condotto con l'Istituto iBraiN, ha dimostrato che MB-204 (10 mg/kg orale giornaliero) ha superato significativamente Trofinetide (100 mg/kg iniettato giornalmente) su più parametri in topi Mecp2 durante un periodo di trattamento di due settimane:
- MB-204 ha invertito le carenze comportamentali sociali nel toccare il naso e la zampa (p<0.0001 vs controllo)
- MB-204 ha invertito i deficit nel comportamento di seguire (p<0.0001 vs controllo)
- Entrambi i trattamenti hanno migliorato il comportamento di preferenza sociale nel test delle tre camere
- MB-204 ha invertito le alternanze spontanee e i ritorni nella stessa braccio nel test Y-maze (p<0.0001 vs controllo)
L'analisi degli effetti residui è in corso e sarà pubblicata separatamente. L'azienda prevede di pubblicare e presentare i dati in una prossima conferenza scientifica.
Marvel Biosciences (TSXV: MRVL, OTCQB: MBCOF) ha publicado datos finales parciales de su estudio preclínico sobre el síndrome de Rett, comparando su compuesto principal MB-204 con Trofinetide, el único tratamiento aprobado por la FDA y Health Canada para esta condición.
El estudio, realizado con el Instituto iBraiN, demostró que MB-204 (10 mg/kg oral diario) superó significativamente a Trofinetide (100 mg/kg inyectado diariamente) en múltiples puntos finales en ratones Mecp2 durante un período de tratamiento de dos semanas:
- MB-204 revirtió las deficiencias de comportamiento social en el contacto con la nariz y la pata (p<0.0001 vs control)
- MB-204 revirtió las deficiencias en el comportamiento de seguimiento (p<0.0001 vs control)
- Ambos tratamientos mejoraron el comportamiento de preferencia social en la prueba de tres cámaras
- MB-204 revirtió las alternancias espontáneas y los retornos al mismo brazo en la prueba Y-maze (p<0.0001 vs control)
El análisis de los efectos de arrastre está en curso y se publicará por separado. La empresa planea publicar y presentar los datos en una próxima conferencia científica.
Marvel Biosciences (TSXV: MRVL, OTCQB: MBCOF)는 자폐증의 한 형태인 레트 증후군에 대한 전임상 연구의 부분 최종 데이터를 발표했습니다. 이 연구에서는 주 성분인 MB-204와 FDA 및 캐나다 보건부에서 승인한 유일한 치료제인 Trofinetide를 비교했습니다.
iBraiN 연구소와 함께 진행된 이 연구는 MB-204 (10 mg/kg 경구 복용)가 Trofinetide (100 mg/kg 주사)보다 여러 평가 지표에서 두 주간의 치료 기간 동안 유의미하게 우수하다는 것을 보여주었습니다:
- MB-204는 코와 발을 만지는 사회적 행동 결핍을 역전시켰습니다 (p<0.0001 대 조절군)
- MB-204는 추적 행동의 결함을 역전시켰습니다 (p<0.0001 대 조절군)
- 두 치료 모두 세 개의 방 테스트에서 사회적 선호 행동을 개선했습니다
- MB-204는 Y-미로 테스트에서 자발적 교대 및 동일한 팔로의 복귀를 역전시켰습니다 (p<0.0001 대 조절군)
잔여 효과 분석이 진행 중이며 별도로 발표될 예정입니다. 회사는 데이터의 출판 및 발표를 예정된 과학 회의에서 할 계획입니다.
Marvel Biosciences (TSXV : MRVL, OTCQB : MBCOF) a publié des données finales partielles de son étude préclinique sur le syndrome de Rett, comparant son composé principal MB-204 avec Trofinetide, le seul traitement approuvé par la FDA et Santé Canada pour cette condition.
L'étude, réalisée avec l'Institut iBraiN, a montré que MB-204 (10 mg/kg par voie orale chaque jour) surpasse significativement Trofinetide (100 mg/kg injecté chaque jour) sur plusieurs critères chez des souris Mecp2 pendant une période de traitement de deux semaines :
- MB-204 a inversé les déficits de comportement social dans le test de contact du nez et de la patte (p<0.0001 vs contrôle)
- MB-204 a inversé les déficits dans le comportement de suivi (p<0.0001 vs contrôle)
- Les deux traitements ont amélioré le comportement de préférence sociale dans le test des trois chambres
- MB-204 a inversé les alternances spontanées et les retours au même bras dans le test Y-maze (p<0.0001 vs contrôle)
L'analyse des effets résiduels est en cours et sera publiée séparément. L'entreprise prévoit de publier et de présenter les données lors d'une prochaine conférence scientifique.
Marvel Biosciences (TSXV: MRVL, OTCQB: MBCOF) hat teilweise endgültige Daten aus seiner präklinischen Studie zum Rett-Syndrom veröffentlicht, in der die Hauptverbindung MB-204 mit Trofinetide verglichen wurde, dem einzigen von der FDA und Health Canada zugelassenen Behandlungsmittel für diese Erkrankung.
Die Studie, die in Zusammenarbeit mit dem iBraiN-Institut durchgeführt wurde, zeigte, dass MB-204 (10 mg/kg oral täglich) Trofinetide (100 mg/kg täglich injiziert) in mehreren Endpunkten bei Mecp2-Mäusen über einen zweiwöchigen Behandlungszeitraum signifikant übertraf:
- MB-204 kehrte soziale Verhaltensdefizite im Nasen- und Pfotenberühren um (p<0.0001 vs Kontrolle)
- MB-204 kehrte Beeinträchtigungen im Verhaltensfolgen um (p<0.0001 vs Kontrolle)
- Beide Behandlungen verbesserten das soziale Präferenzverhalten im Dreikammer-Test
- MB-204 kehrte spontane Alternationen und Rückkehr zum selben Arm im Y-Maze-Test um (p<0.0001 vs Kontrolle)
Die Analyse der Nachwirkungen ist noch im Gange und wird separat veröffentlicht. Das Unternehmen plant, die Daten auf einer bevorstehenden wissenschaftlichen Konferenz zu veröffentlichen und zu präsentieren.
- MB-204 demonstrated superior efficacy compared to FDA-approved Trofinetide across multiple endpoints
- MB-204 is administered orally once daily vs. Trofinetide's injectable administration
- Lower dosage requirement for MB-204 (10mg/kg) compared to Trofinetide (100mg/kg)
- Statistically significant improvements in multiple behavioral metrics (p<0.0001)
- Study results are preclinical (animal testing phase) - still far from market approval
- Complete data set not yet available
- Carry-over effects analysis still pending
Calgary, Alberta--(Newsfile Corp. - March 13, 2025) - Marvel Biosciences Corp. (TSXV: MRVL) (OTCQB: MBCOF) and its wholly owned subsidiary, Marvel Biotechnology Inc. (collectively the "Company" or "Marvel"), is pleased to share part of the final data from its preclinical Rett syndrome study conducted in collaboration with the iBraiN Institute.
The study evaluated MB-204, Marvel's lead compound (10 mg/kg oral once daily), in comparison to Trofinetide (100 mg/kg injected once daily), the only FDA and Health Canada approved treatment for Rett syndrome. Mecp2 mice were treated for approximately two weeks with either compound, and multiple endpoints were assessed while on drug treatment. Analysis of the carry-over effect of MB-204 and Trofinetide is ongoing and will be released separately.
Key Data Highlights:
- MB-204 reversed social behavioural deficiencies as measured by the number and duration of nose touching and the number and duration of paw touching (p<0.0001 vs control). Trofinetide showed no improvement and MB-204 was significantly better than Trofinetide on the same endpoints (p<0.0001).
- MB-204 also reversed impairments in following behaviour (p<0.0001 vs control). Trofinetide showed no improvement and MB-204 was significantly better than Trofinetide on the same endpoint (p<0.001).
- Both MB-204 and Trofinetide reversed social preference behaviour measured by the three-chamber test (both p<0.0001 vs control). The three-chamber test is one of the most commonly used methods for evaluating social behavior in mouse models of autism spectrum disorder.
- MB-204 reversed the percentage of spontaneous alternations (%SPA) and the percentage of same arm returns (%SAR) in the Y-maze test (p<0.0001 vs control). Trofinetide showed no improvement and MB-204 was significantly better than Trofinetide on the same endpoints (p<0.0001). SPA typically measures spatial working memory and repetitive behaviours. SAR also reflects repetitive behaviour which often occurs in autism and obsessive-compulsive disorders models.
"We are very grateful to our collaborators for this excellent data, which clearly suggests MB-204 could be a very promising treatment for Rett Syndrome," said Chief Science Officer Dr. Mark Williams. "We also look forward to the remainder of the data, where we see how long the effect of MB-204 lasts after treatment has stopped."
The Company and its collaborators intend to publish and present the data at an upcoming scientific conference.
About Marvel Biosciences Corp.
Marvel Biosciences Corp., and its wholly owned subsidiary, Marvel Biotechnology Inc., is a Calgary-based pre-clinical stage pharmaceutical development biotechnology company. The Company is developing MB-204, a novel fluorinated derivative of the approved anti-Parkinson's drug Istradefylline, the only clinically approved adenosine A2a antagonist. A significant and growing body of scientific evidence suggests drugs that block the adenosine A2a receptor, such as MB-204, could be useful in treating other neurological diseases such as autism, depression and Alzheimer's Disease. The Company is actively investigating its potential in addressing other neurodevelopmental disorders, such as Rett Syndrome and Fragile X Syndrome, to expand its therapeutic reach.
Contact Information:
Marvel Biosciences Corp.
J. Roderick (Rod) Matheson, Chief Executive Officer or
Dr. Mark Williams, President and Chief Science Officer
Tel: 403 770 2469
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSXV) accepts responsibility for the adequacy or accuracy of this press release. All information contained in this news release with respect to the Company and its subsidiary, (collectively, the "Parties") were supplied by Marvel, respectively, for inclusion herein and each parties' directors and officers have relied on each other for any information concerning such Party.
This news release may contain forward-looking statements and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of the Company are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those anticipated in such statements. Important factors that could cause actual results to differ materially from the expectations of the Company and include other risks detailed from time to time in the filings made by the Company under securities regulations.
The reader is cautioned that assumptions used in the preparation of any forward-looking information may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company. As a result, the Company cannot guarantee that the above events on the terms will occur and within the time disclosed herein or at all. The reader is cautioned not to place undue reliance on any forward-looking information. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company will update or revise publicly any of the included forward-looking statements as expressly required by Canadian securities law.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/244351
FAQ
How does Marvel's MB-204 compare to Trofinetide in treating Rett syndrome symptoms?
What dosage of MB-204 was used in Marvel's Rett syndrome study (MBCOF)?
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