Marvel Biosciences Reports MB-204 as Highly Effective at Treating Autism Behaviours in Shank3 Mouse Model

The higher MB-204 dose outperformed Istradefylline on most measured endpoints, with final statistical analyses still pending.

Rhea-AI Summary

Marvel Biosciences (MBCOF) reported preliminary MB-204 results showing improvements in autism-related behaviours in a mouse model associated with Phelan-McDermid syndrome. The Shank3 study compared oral MB-204 doses of 1 mg/kg and 2.5 mg/kg with Istradefylline at 1 mg/kg. Low-dose MB-204 matched or exceeded the comparator on most measured endpoints; the higher dose was superior on most endpoints. MB-204 improved multiple behavioural measures versus untreated Shank3 mice.

Final statistical analyses and additional endpoints remain pending, and further analysis may change individual endpoint interpretations. Marvel views the findings, alongside earlier results in genetically distinct models, as support for evaluating MB-204's potential across neurodevelopmental disorders.

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Positive

• Moderate pointMB-204 at both tested doses improved multiple behavioural endpoints versus untreated Shank3 mice in preliminary results.
• Minor point1 mg/kg MB-204 matched Istradefylline on nose-contact and paw-contact counts and times, grooming counts and same-arm returns.
• Minor point1 mg/kg MB-204 outperformed Istradefylline on mean paw-contact duration, following episodes, spontaneous and alternate-arm returns.
• Minor point2.5 mg/kg MB-204 outperformed Istradefylline on most endpoints, matching grooming counts, rearing episodes and same-arm returns.
• Minor pointPreviously reported Oprm1 results showed restored social interaction and improved repetitive behaviours after oral MB-204.

2 minor points

• Minor pointPreviously reported Rett-model results showed near-reversal of social and behavioural deficits and outperformance of Trofinetide across multiple endpoints.
• Minor pointPreviously reported Fragile X results showed statistically significant behavioural and cognitive improvements, including effects after treatment cessation.

Negative

• Minor point. Forward-looking: it has not happened yet and may not happen.Final statistical analyses and additional endpoints remain pending; further analyses may modify individual endpoint interpretations.
• Minor pointRearing episodes were the only endpoint where Istradefylline was more effective than 1 mg/kg MB-204.

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CALGARY, Alberta, Oct. 08, 2026 (GLOBE NEWSWIRE) -- Marvel Biosciences Corp. (TSXV: MRVL | OTCQB: MBCOF), and its wholly-owned subsidiary, Marvel Biotechnology Inc. (collectively the “Company” or “Marvel”), a drug discovery company developing novel therapeutics for autism spectrum disorder (“ASD”) and related neurodevelopmental disorders, is pleased to announce preliminary results from its preclinical study of MB-204 in the Shank3Δex13-16 mouse model, a model associated with Phelan-McDermid syndrome. The study was conducted in collaboration with Dr. Julie Le Merrer and Dr. Jérôme Becker at the iBraiN Institute in Tours, France, and evaluated MB-204 at oral doses of 1 mg/kg and 2.5 mg/kg compared with Istradefylline at 1 mg/kg, the highest dose tested that did not affect locomotion.   Animals were studied for one to three hours post dosing. Istradefylline is a clinically approved drug for the treatment of Parkinson’s Disease.

Preliminary Results Demonstrate Broad Activity of MB-204

The preliminary results indicate that MB-204 produced improvements across multiple behavioural endpoints associated with repetitive and abnormal behaviours in the Shank3 model. MB-204 continues to demonstrate activity across increasingly diverse genetic models, supported by the emerging Shank3 data, potentially advancing a broader therapeutic opportunity as the company approaches human clinical development.

Key Data Highlights

• Low-dose MB-204 (1 mg/kg) matched or exceeded Istradefylline across the majority of measured endpoints: performance was matched on the number and time of nose contacts, number and time of paw contacts, the number of grooming episodes and number of same arm returns (SARs) in the Y-maze test of repetitive behaviour.
• Low dose of MB-204 demonstrated superior performance to Istradefylline on the mean duration of paw contacts, number of following episodes and the number of spontaneous and alternate arm returns (AARs) in the Y-maze. Only the number of rearing episodes was Istradefylline more effective than low dose MB-204.
• High-dose MB-204 (2.5 mg/kg) was superior to Istradefylline across the majority of measured endpoints: performance was matched only in the number of grooming episodes, rearing episodes and SARs. On all other endpoints as per above, MB-204 was superior to Istradefylline.
• All treatments showed demonstrable improvement in multiple behavioural endpoints over untreated Shank3 animals except for the number of following episodes and AARs in the Istradefylline treated animals.
• The study also provides a direct head-to-head comparison between MB-204 and its parent compound, Istradefylline, supporting the Company's objective of demonstrating differentiated activity for its proprietary fluorinated derivative.
• Final statistical analyses and additional endpoints remain pending.
  
  

* The Company cautions that these are preliminary preclinical findings and that additional analyses may modify the interpretation of individual endpoints.

“This is the third model where MB-204 has had a profound effect on socialization and repetitive behaviours,” said Drs. Le Merrer and Becker, “which are the key hallmarks of autism. MB-204 nearly reversed all the social deficits and repetitive behaviours in the Shank3 model as we previously saw in the Oprm1 mouse model and Rett syndrome models. This study also confirms the superiority of MB-204 over the parental drug Istradefylline in a head-to-head study. Together with the recent Fragile X results, the data suggests MB-204 may be a pan-spectrum treatment for autism. We look forward to presenting the data in upcoming conferences and publishing the data on MB-204 for the wider scientific community to review.”

Expanding Evidence Across Genetically Distinct Neurodevelopmental Models

The Shank3 findings add to a growing body of preclinical evidence generated for MB-204 across genetically distinct models of neurodevelopmental disorders.

Marvel has previously reported positive preclinical results in:

• Oprm1: an autism model in which MB-204 demonstrated restoration of social interaction and improvements in repetitive behaviours following oral administration. 
• Mecp2/Rett syndrome: MB-204 demonstrated near-reversal of social and behavioural deficits and outperformed Trofinetide across multiple endpoints in the Company's disclosed preclinical study. 
• Fragile X (Fmr1): MB-204 produced statistically significant improvements in behavioural and cognitive function, including a carry-over effect after treatment cessation. 
• Shank3: representing another genetically distinct model associated with autism and Phelan-McDermid syndrome.
  
  

The Company believes that the emergence of consistent behavioural activity across models associated with different underlying genetic causes may be important in evaluating the potential breadth of MB-204's mechanism and therapeutic application.

“The Shank3 results are particularly encouraging because they add another genetically distinct model to the growing body of evidence supporting MB-204,” said Dr. Mark Williams, President and Chief Science Officer of Marvel Biosciences. “Together with our previously reported Oprm1, Mecp2 and Fragile X results, these findings continue to support our hypothesis that targeting the adenosine A2A receptor may address behavioural and social deficits across multiple neurodevelopmental disorders. We look forward to completing the statistical analysis and presenting the full dataset to the scientific community.”

About Marvel Biosciences Corp.

Marvel Biosciences Corp. (TSXV:MRVL | OTCQB:MBCOF), 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
Email: rod@marvelbiosciences.com
Dr. Mark Williams, President and Chief Science Officer
Email: mark@marvelbiosciences.com
Tel: 403 770 2469

Website: www.marvelbiotechnology.com    |   Twitter/X   |   LinkedIn

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.

FAQ

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What did Marvel Biosciences report about MB-204 in the Shank3 mouse study?

Preliminary results showed MB-204 matched or exceeded Istradefylline on most measured behavioural endpoints at 1 mg/kg and was superior on most endpoints at 2.5 mg/kg. The study used a Shank3 mouse model associated with Phelan-McDermid syndrome, and final statistical analyses remain pending.

How was Marvel Biosciences' MB-204 Shank3 study conducted?

The study evaluated mice one to three hours after dosing, in collaboration with Dr. Julie Le Merrer and Dr. Jérôme Becker at the iBraiN Institute in Tours, France. Istradefylline was tested at 1 mg/kg, the highest tested dose that did not affect locomotion.