CRDL - Hope on the Horizon: Results from MAvERIC-Pilot Show Heartfelt Progress for Patients
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In a phenomenal yearmarked by over +180% gains in its stock price, Cardiol TherapeuticsInc. (NASDAQ: CRDL) (TSX: CRDL) added another feather to its caplast week with the announcement of its Phase II MAvERIC-Pilot studytopline results.
The Canadian biotechnology company has captured investors’attention this year with significant milestones achieved, includingthe advancement of two simultaneous Phase II clinical trials, grantingof Orphan Drug Designation by the US FDA for its flagship drugCardiolRx™, and most recently, the announcement of positive toplineresults from their MAvERIC-Pilot study. These achievements furthersolidify Cardiol Therapeutics' position as a formidable player inthe biotech landscape, offering renewed hope to patients sufferingfrom debilitating rare heart conditions.
Last week, Cardiol Therapeutics (NASDAQ:CRDL) (TSX: CRDL) reported 8-week clinical data from its Phase IIopen-label MAvERIC-Pilot study investigating the impact ofCardiolRx™ administered to patients with symptomatic recurrentpericarditis. The study enrolled 27 adult patients with symptomaticrecurrent pericarditis at eight clinical sites across the UnitedStates, including the prominent Mayo Clinic, Cleveland Clinic, andMassachusetts General Hospital. Each patient had a high burden ofdisease, as reflected by both a patient-reported pain score averaging5.8 out of 10 at baseline and the number of previous episodes ofpericarditis (9 patients, or 33%, had 2 previous episodes, 9 patients,or 33%, had 3 such episodes, 4 patients, or 15%, had 4 episodes, and 5patients, or 19%, had more than 4 episodes).
The primary endpoint ofthe Phase II study is the change in patient-reported pericarditis painat eight weeks, as measured by an 11-point numeric rating scale (NRS)that has been validated and applied in several clinical trials. NRS iscommonly used to assess pain severity by using a scale from 0 to 10,where zero is "no pain" and 10 is "the worst painimaginable.". Secondary endpoints include the NRS score after 26weeks of treatment and changes in circulating levels of C-reactiveprotein (CRP). CRP is a commonly used marker of inflammation inpatients with cardiovascular disease.
MAvERIC-Pilot topline data revealedseveral key findings:
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Efficacy in Pain Reduction: Patientstreated with CardiolRx™ experienced a significant reduction in thesubjectively perceived pain of the pericarditis. The mean pain scoredropped from 5.8 at baseline to 2.1 (64%) after eight-weeks oftreatment, marking a decrease of 3.7 points on the 11-pointNRS.
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Reduction in Inflammation: Among patients with elevatedbaseline CRP (?1 mg/dL), 80% achieved normalization of CRP levels(?0.5 mg/dL) at the end of the eight-week treatment period. Theaverage CRP levels were reduced from 5.7 mg/dL to 0.3 mg/dL,indicating a substantial reduction in inflammation.
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PatientContinuation and Safety: A significantly high percentage ofpatients (89%) have continued into the extension phase of the study,an 18-week treatment period, suggesting that CardiolRx™ iswell-tolerated. The study also confirmed that CardiolRx™ was foundto be safe and well tolerated, with no significant adverseeffects.
David Elsley, President & CEO of Cardiol Therapeutics,expressed optimism about the potential of CardiolRx™ as anon-immunosuppressive therapeutic option for pericarditis. Mr. Elsleyhighlighted the drug’s comparable efficacy to existing biologictherapies used in third-line treatment of recurrentpericarditis:
“ We are delighted to share the exceptional primaryendpoint data from the MAvERIC-Pilot study, which demonstrated thatoral administration of our small molecule CardiolRx™ led to markedreductions in pericarditis pain and inflammation, and remarkably,these reductions are comparable in magnitude to biologic therapycommonly used in third-line treatment of recurrent pericarditis. Basedon the clinically meaningful impact of CardiolRx™ on the key symptomof this debilitating disease, we now anticipate that the totality ofthe MAvERIC-Pilot data will support advancing to a Phase III trial ofCardiolRx™ designed to meet our objective of providing an accessibleand non-immunosuppressive therapeutic option for thousands ofpericarditis patients. ”
Recurrent pericarditis, a persistent inflammationof the pericardium – the protective membrane surrounding the heart– often resurfaces following an initial episode, frequently linkedto viral infections. This condition is marked by intense chest pain,shortness of breath, and debilitating fatigue, which results insignificant physical limitations and a diminished quality of life forpatients. With an estimated 38,000 patients in the U.S. experiencingat least one recurrence annually, and many suffering for years, theneed for effective treatments is critical. Approximately 60% ofpatients with multiple recurrences (>1) still suffer for longerthan two years, and one third are still impacted at five years.Moreover, the progressive accumulation of pericardial fluid andsubsequent scarring can escalate to a life-threatening constriction ofthe heart, highlighting an urgent need for advancements in medicaltreatment and patient care protocols.
The only FDA-approved therapy for recurrentpericarditis, launched in 2021, is costly and primarily used as athird-line intervention. However, CardiolRx™’s tolerability andside effect profile is expected to be much more favourable than thecurrent treatment – which has risks typical of immunosuppressants.The economic burden is notable, with frequent emergency room visitsand hospitalizations driving up healthcare costs. Hospitalization dueto recurrent pericarditis is often associated with a 6-8-day length ofstay, and the cost per stay is estimated to range between $20,000 and$30,000 in the United States.
Buildingon the impressive topline results from the MAvERIC-Pilot study,Cardiol Therapeutics is poised to provide patients with an accessibleand non-immunosuppressive treatment option for recurrent pericarditis,potentially surpassing existing therapies. These encouraging outcomesset the stage for a forthcoming Phase III trial, aiming to furthervalidate the efficacy and safety of CardiolRx™, as CardiolTherapeutics progresses towards commercialization.
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