jobynimble
3 months ago
Cardiol Therapeutics (NASDAQ:CRDL) is a Canadian biotech drug developer focused on developing their novel ultrapure cannabidiol formulation, CardiolRx™, for rare inflammatory heart diseases, specifically recurrent pericarditis and acute myocarditis.
Pericarditis is characterized as inflammation of the pericardium, layers of tissue that surround the heart, that affects about 165,000 people in the U.S. annually and has no first-line FDA-approved treatment. Among those treated for acute pericarditis, 15% to 30% may experience recurrent pericarditis.
Currently, anti-inflammatory drugs such as colchicine are prescribed for pericarditis treatment in cases of chronic or recurrent pericarditis. If the patient with pericarditis disease does not respond to anti-inflammatory medications, corticosteroids such as prednisone are prescribed.
More recently, Kiniksa Pharmaceuticalsโ ARCALYST® (rilonacept) became the first and only FDA-approved treatment indicated for the treatment of recurrent pericarditis and the reduction in risk of recurrence in adults and children 12 years and older.
ARCALYST is a weekly subcutaneous injection, whereas CardiolRx™ is an oral drug taken twice daily which is a major advantage as the idea of weekly injections could not be as appealing to patients.
Cardiol Therapeuticsโ (NASDAQ:CRDL) pre-clinical models showed that by inhibiting activation of the NLRP3 inflammasome pathway, cannabidiol may help resolve the symptoms of pericarditis.
This approach has already demonstrated incredible potential, as the company was granted Orphan Drug Designation (ODD) by the U.S. FDA for the treatment of pericarditis, which includes recurrent pericarditis.
Cardiol Therapeutics followed this major achievement with completing enrollment in its Phase 2, open-label MAvERIC-Pilot study investigating the tolerance, safety, and effect of CardiolRx™ in patients with recurrent pericarditis. The primary endpoint of the trial is the change in patient-reported pericarditis pain using an 11-point numeric rating scale (NRS) from baseline to week 8 with topline results expected in early June.
Not only that, Cardiol Therapeutics recently presented its concurrent Phase II ARCHER trial design at the annual congress of the Heart Failure Association of the European Society of Cardiology. This demonstrated the high level of interest from the cardiology community in novel approaches to treat acute myocarditis, for which there are currently no therapies approved by European and US regulatory authorities.
The ARCHER trial is expected to enroll 100 patients at pre-eminent cardiovascular research centers in the United States, Canada, France, Brazil, and Israel. Patient recruitment has been accelerating due in large part to the growing global awareness of myocarditis, and ARCHER has already exceeded 85% of target enrollment.
Cardiol Therapeutics (NASDAQ:CRDL) expects that results from the ARCHER trial will assist in furthering its understanding of the therapeutic potential of CardiolRx™ and will complement the more advanced MAvERIC-Pilot Phase II study in patients with recurrent pericarditis.
Just to put the opportunity here in context, Future Market Insights expects that the worldwide pericarditis treatment market is likely to be worth $ 6 billion by 2032. ARCALYSTโs sales further reaffirm this considering that the drugโs 2023 net revenue grew 90% year-over-year to $233.1 million.
Several analysts have maintained their positive outlook on the company and have high hopes that the June data will further prove CardiolRx™ efficacy in treating recurrent pericarditis. In fact, Joe Gantoss of Chimera Research Group notes, โI wonโt be surprised to see the price breaking out the 3-year high at $4.96 if the recurrent-pericarditis data show a clear success and open the path to move to the next stage with Phase-3 trial,โ while analysts at H.C Wainwright & Co. issued a $9 price target for the stock.