Impact of CardiolRxTM on Recurrent Pericarditis (MAvERIC-Pilot)
Summary
Patients with recurrent pericarditis who are refractory or intolerant to current therapeutic management options or who require long-term administration of corticosteroids to control their disease are particularly challenging to manage. The pathogenesis of pericarditis involves the activation of the inflammasome. CardiolRxTM (a pure cannabidiol \[CBD\] solution) is known to have anti-inflammatory properties, including modulation of inflammasome signaling. This pilot study is to assess the tolerance and safety of CardiolRxTM during the resolution of pericarditis symptoms, assess improvement in objective measures of disease, and during the extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids while taking CardiolRxTM.
Timeline
- Start
- 2023-01-09
- Primary completion
- 2024-06-15
- Completion
- 2024-09-06
Outcome
Met primary endpoint
release “primary endpoint data from the MAvERIC-Pilot study, demonstrating that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain” cardiolrx.com ↗
release “positive primary endpoint data from the MAvERIC-Pilot study” cardiolrx.com ↗
release “The Company previously announced positive topline data from MAvERIC-Pilot investigating CardiolRx™ for recurrent pericarditis which showed a substantial reduction in the primary efficacy endpoint” cardiolrx.com ↗
Publications
- Background Adler Y, Charron P, Imazio M, Badano L, Baron-Esquivias G, Bogaert J, Brucato A, Gueret P, Klingel K, Lionis C, Maisch B, Mayosi B, Pavie A, Ristic AD, Sabate Tenas M, Seferovic P, Swedberg K, Tomkowski W; ESC Scientific Document Group. 2015 ESC Guidelines for the diagnosis and management of pericardial diseases: The Task Force for the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology (ESC)Endorsed by: The European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2015 Nov 7;36(42):2921-2964. doi: 10.1093/eurheartj/ehv318. Epub 2015 Aug 29. No abstract available.
- Background Klein AL, Imazio M, Cremer P, Brucato A, Abbate A, Fang F, Insalaco A, LeWinter M, Lewis BS, Lin D, Luis SA, Nicholls SJ, Pano A, Wheeler A, Paolini JF; RHAPSODY Investigators. Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis. N Engl J Med. 2021 Jan 7;384(1):31-41. doi: 10.1056/NEJMoa2027892. Epub 2020 Nov 16.
- Luis SA, Klein AL, Cremer PC, Abbate A, Salik JR, Thomas GK, Haider SW, Hagerty TE, Lin D, Waggoner TE, Nicholls SJ, Kirwan BA, Narine KAD, Parker AB, Hamer A. Efficacy and Safety of Pharmaceutically Manufactured Cannabidiol in Recurrent Pericarditis: A Phase II Clinical Trial. J Am Heart Assoc. 2026 Jul 10:e047605. doi: 10.1161/JAHA.125.047605. Online ahead of print.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cannabidiol | Other / unclassified | 10 mg/kg | Oral |