February 15, 2024 (Investorideas.com Newswire) Investorideas.com (www.investorideas.com) Life Sciences Stock News Bites- Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) , a clinical-stage life sciences company focused on the research and clinical development of anti-inflammatory and anti-fibrotic therapies for the treatment of heart disease, announces that the United States Food and Drug Administration (“FDA”) has granted Orphan Drug Designation (“ODD”) for the Company’s lead small molecule drug candidate for the treatment of pericarditis, which includes recurrent pericarditis. CardiolRx™ is currently in Phase II clinical trials for recurrent pericarditis and acute myocarditis.

“The FDA’s decision was based on pre-clinical data combined with initial clinical data from the Company’s MAvERIC-Pilot Phase II study,” commented Dr. Andrew Hamer, Cardiol Therapeutics’ Chief Medical Officer and Head of Research & Development. “This designation reinforces the potential of CardiolRx™ to improve the lives of patients suffering with recurrent pericarditis, a debilitating heart disease associated with symptoms that adversely affect quality of life and physical activity.”

The FDA grants ODD to a drug or biological product to prevent, diagnose, or treat a rare disease or conditions that affect fewer than 200,000 people in the United States. ODD provides benefits to sponsors including potential seven-year marketing exclusivity, exemptions from certain FDA fees, and tax credits for qualified clinical trials. Products with ODD may also qualify for accelerated regulatory review via Fast Track, Breakthrough Therapy, or Priority Review designations.

MAvERIC-Pilot (NCT05494788) is a Phase II open-label pilot study investigating the tolerance, safety, and effect of CardiolRx™ administered to patients with recurrent pericarditis. In addition to standard safety assessments, MAvERIC-Pilot is designed to evaluate improvement in objective measures of this rare disease. The primary efficacy endpoint is the change, from baseline to eight weeks, in patient-reported pericarditis pain using an 11-point numeric rating scale (“NRS”). The NRS is a validated clinical tool employed across multiple conditions with acute and chronic pain, including previous studies of recurrent pericarditis. Secondary endpoints include the NRS score after 26 weeks of treatment, and changes in circulating levels of C-reactive protein, a commonly used clinical marker of inflammation. Importantly, the study will assess freedom from pericarditis recurrence.

Recurrent pericarditis refers to inflammation of the pericardium (the membrane or sac that surrounds the heart) that follows an initial episode (frequently resulting from a viral infection). Patients may have multiple recurrences. Symptoms include debilitating chest pain, shortness of breath, and fatigue, resulting in physical limitations, reduced quality of life, emergency department visits, and hospitalizations. Significant accumulation of pericardial fluid and scarring can progress to life-threatening constriction of the heart. The only FDA-approved therapy for recurrent pericarditis, launched in 2021, is costly and is primarily used as a third-line intervention. On an annual basis, the number of patients in the United States having experienced at least one recurrence is estimated at 38,000. Approximately 60% of patients with multiple recurrences (>1) still suffer for longer than 2 years, and one third are still impacted at 5 years. Hospitalization due to recurrent pericarditis is often associated with a 6-8-day length of stay and cost per stay is estimated to range between $20,000 and $30,000 in the United States.

Read the company’s full news and disclaimer here:

https://www.cardiolrx.com/cardiol-therapeutics-granted-orphan-drug-designation-for-its-lead-drug-candidate-for-the-treatment-of-pericarditis/

Research  more biotech stocks with Investorideas.com stock directory

https://www.investorideas.com/BIS/Stock_List.asp

About Investorideas.com – Big Investing Ideas

Investorideas.com is the go-to platform for big investing ideas. From breaking stock news to top-rated investing podcasts, we cover it all. Our original branded content includes podcasts such as Exploring Mining, Cleantech, Crypto Corner, Cannabis News, and the AI Eye. We also create free investor stock directories for sectors including mining, crypto, renewable energy, gaming, biotech, tech , sports and more. Public companies within the sectors we cover can use our news publishing and content creation services to help tell their story to interested investors. Paid content is always disclosed.

Disclaimer/Disclosure: Investorideas.com is a digital publisher of third party sourced news, articles and equity research as well as creates original content, including video, interviews and articles. Original content created by investorideas is protected by copyright laws other than syndication rights. Our site does not make recommendations for purchases or sale of stocks, services or products. Nothing on our sites should be construed as an offer or solicitation to buy or sell products or securities. All investing involves risk and possible losses. This site is currently compensated for news publication and distribution, social media and marketing, content creation and more. Disclosure is posted for each compensated news release, content published /created if required but otherwise the news was not compensated for and was published for the sole interest of our readers and followers. Contact management and IR of each company directly regarding specific questions. More disclaimer info: More disclaimer and disclosure info https://www.investorideas.com/About/Disclaimer.asp  Learn more about publishing your news release and our other news services on the Investorideas.com newswire https://www.investorideas.com/News-Upload/ and tickertagstocknews.com Global investors must adhere to regulations of each country. Please read Investorideas.com privacy policy: https://www.investorideas.com/About/Private_Policy.asp

Follow us on Twitter @investorideas and @stocknewsbites

Follow us on Facebook https://www.facebook.com/Investorideas

Follow us on YouTube https://www.youtube.com/c/Investorideas

Sign up for free stock news alerts at Investorideas.com

https://www.investorideas.com/Resources/Newsletter.asp

Contact Investorideas.com

800 665 0411

Life Sciences Stock News Bite

Buy a biotech guest post on Investorideas.com

Leave A Reply