Cardiol Therapeutics Inc. (Nasdaq: CRDL) (TSX: CRDL) is a life sciences company focused on anti-inflammatory and anti-fibrotic therapies for the treatment of poorly served heart diseases. Cardiol recently wrapped up a successful Phase 2 trial, testing its lead drug candidate that the FDA has granted Orphan Drug Designation, CardiolRx™, for its impact on recurrent pericarditis.
Based on the positive results from the trial, the company is moving forward with two advanced trials that will run concurrently. One is a Phase 2/3 trial, and the other a Phase 3 study. Should those go well, Cardiol anticipates filing for commercial approval from the United States Food and Drug Administration (FDA).
Cardiol is currently conducting a Phase 2 trial to study the effects of CardiolRx™ on acute myocarditis, another indication that would qualify for the Orphan Drug Designation. Meanwhile, the company is conducting research and development to enable an Investigational New Drug filing for CRD-38 in the treatment of heart failure. Heart failure is one of the most prevalent and deadly diseases in the world.
Cardiol’s CEO, David Elsley, recently did an interview with The Deep Dive, an investor channel focused on Canadian public companies. The interview covers Cardiol’s research and development program thoroughly. Here we’ll look at a few interesting discussions from the interview. You can see the full interview by following this link.
Pericarditis Market
Pericarditis is the inflammation of the membrane that surrounds the heart and is usually the result of a viral infection. In the US, anywhere from 160,000 to 200,000 people suffer from pericarditis annually. As many as 38,000 Americans suffer from recurrent pericarditis each year, in which the disease continues to come back time and again. These people have symptoms recurring for as long as five to six years, and the symptoms are not fun. Shortness of breath, severe chest pain, fatigue, and depression are common, and severe cases can require hospitalization.
Anti-inflammatories and steroids are used to treat the symptoms but offer their own negative side effects. If those don’t curb the disease, there is one treatment on the market that costs up to $270,000/year and creates troublesome side effects. Suffice to say there is room for another FDA-approved treatment that can improve or replace current treatments without side effects and for less money. That’s what Cardiol believes it has with CardiolRx™.
Phase 2 Trial Results
Last week, Cardiol presented its findings from the Phase 2 recurrent pericarditis trial at the American Heart Association Scientific Sessions 2024. Participants were taking CardiolRx™ alongside their prescribed medications (colchicine, NSAIDs, and corticosteroids) for the first 8 weeks, and were weaned off these medications in the extension period for CardiolRx™ to be evaluated on its own.
With CardiolRx™ administered, their symptoms changed significantly for the better. On a pain scale of 0-10, with 10 being the highest, patients reported a reduction from an average of 5.8 at the beginning of the trial to an average of 1.5 at week 26. Remember, they were weaned off the other drugs following the eight-week mark, at which point they reported pain scores averaging 2.1.
CardiolRx™ acted quickly to reduce the pain, with the median time to achieve a pericarditis pain score of 2 or less taking just five days. Recurrences were reduced, on average, from 5.8 episodes per year to 0.9 episodes per year for patients in the full 26-week program. 71% of those patients experienced no recurrence at all during the study period, including the extended period, in which they had been taken off their prescribed medications and CardiolRx™ was their only treatment.
Drug Development Timeline
Cardiol’s recurrent pericarditis and acute myocarditis programs are both on a fast track in terms of their development timelines due to both being orphan indications, affecting less than 200,000 patients annually in the US. The FDA works with companies to speed drug development for rare diseases like these, significantly shortening the timeline and associated costs of the clinical trial program while also offering market exclusivity upon approval.
Cardiol is entering the final phases of clinical development of CardiolRx™ for the treatment of recurrent pericarditis, and could be ready for a final approval submission in as early as 15 months.
The Upshot
The company behind the only FDA-approved treatment for recurrent pericarditis, Kiniksa Pharmaceuticals, currently trades with a market capitalization of approximately $1.5 billion with only the one FDA approved drug in its arsenal. This is the type of opportunity that lies in front of Cardiol, currently valued around $130 million. And Cardiol has the Phase 2 acute myocarditis program nearing data readout in Q1 2025 as another catalyst for investors to be excited about.
Of course, there is no guarantee of success for any company developing pharmaceuticals, but the results so far are very promising. Check out the full interview, and put Cardiol Therapeutics on your radar if it’s not already there.
