Cardiol Therapeutics Inc. (CRDL:TSX; CRDL:NASDAQ) is set to advance its CardiolRx into Phase III trials for recurrent pericarditis following positive Phase II data from the MAvERIC trial. The announcement follows a research note by Leede Financial Inc., highlighting the sustained efficacy and safety profile of CardiolRx.
The MAvERIC trial evaluated CardiolRx in patients with recurrent pericarditis, demonstrating significant and sustained pain relief. According to Leede Financial Inc. analyst Dr. Douglas Loe, patients treated with CardiolRx experienced a notable reduction in pain, with average pain scores on the eleven-point numerical rating scale (NRS) decreasing from 5.8 at enrollment to 1.5 at the six-month analysis.
Favorable Comparison to Existing Treatments
Dr. Loe's analysis emphasized CardiolRx's competitive performance against existing treatments. "MAvERIC eight-week NRS data actually compares favorably to rilonacept's NRS data at the equivalent timepoint in RHAPSODY," Loe stated. He also noted that CardiolRx effectively normalizes circulating CRP levels, a key marker of inflammation, although the effect was not as rapid as that observed with rilonacept in the RHAPSODY trial.
Advancing to Phase III Trials
Based on these promising results, Cardiol Therapeutics is moving forward with two Phase II/III trials. One of these trials, MAvERIC-2, will specifically enroll 110 patients who have previously been treated with rilonacept but discontinued the medication. This targeted approach aims to address a significant unmet need in patients who have not responded adequately to existing therapies.
Upcoming Milestones
In addition to the recurrent pericarditis program, Cardiol Therapeutics anticipates several key milestones in the near future. New Phase II testing in recurrent pericarditis is expected to commence "in a month or two," and Phase II data from the 100-patient ARCHER trial in acute myocarditis is expected by FQ225.
Investment Perspective
Leede Financial maintained a Speculative Buy rating on Cardiol Therapeutics with a target price of CA$11.00. This valuation is based on a combination of NPV analysis (using a 25% discount rate) and multiples of projected EBITDA/EPS for F2028. The analyst's target price represents a potential return of approximately 333% from the share price at the time of the report (CA$2.54).
CardiolRx's Potential
The sustained efficacy and favorable safety profile of CardiolRx in the MAvERIC trial support its potential as a valuable treatment option for patients with recurrent pericarditis. The upcoming Phase II/III trials will further evaluate its efficacy and safety, potentially paving the way for regulatory approval and commercialization.
