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Be the first with the news that moves the market- Algernon Pharmaceuticals (AGN) has been granted Orphan Drug Designation (ODD) for Ifenprodil as a treatment for Idiopathic Pulmonary Fibrosis (IPF)
- NP-120 is the company’s lead clinical candidate being developed for the treatment of IPF and chronic cough
- The company recently concluded a Phase 2a study of Ifenprodil in patients with IPF with improvements in patient-reported cough severity and quality of life observed
- Algernon is a Canadian clinical-stage drug development company investigating multiple drugs for unmet global medical needs
- Algernon Pharmaceuticals Inc. (AGN) is up 17.97 per cent on the day, trading at C$3.02 per share at 10 am ET
Algernon Pharmaceuticals (AGN) has been granted Orphan Drug Designation (ODD) for Ifenprodil to treat Idiopathic Pulmonary Fibrosis (IPF).
Ifenprodil is the sole active ingredient in NP-120, an NMDA receptor antagonist and the company’s lead clinical candidate being developed for the treatment of IPF and chronic cough.
The company recently concluded a Phase 2a study of Ifenprodil in patients with IPF. The trial met its co-primary IPF endpoint, with patients receiving Ifenprodil experiencing no worsening of their lung function, and significant improvements were seen in the frequency of their IPF-associated cough as well.
Improvements in patient-reported measures of cough severity and quality of life were observed. Ifenprodil was also confirmed to be safe and well-tolerated in the study.
Supporting the development and evaluation of new treatments for rare diseases through ODD is a priority for the U.S. FDA. The designation is available only for rare diseases, defined by the U.S. FDA as those which affect fewer than 200,000 patients in the United States. ODD qualifies sponsors for incentives, including tax credits for qualified clinical trials and an exemption from user fees.
Christopher J. Moreau, CEO of Algernon, commented on the news.
“We appreciate the U.S. FDA’s decision to grant ODD status to Ifenprodil for IPF, a disease for which prognosis remains dismal, with 50% mortality expected within 3-4 years. This regulatory milestone comes at an important time in the development of Ifenprodil as a potential new therapy for IPF as we plan the next steps for our clinical program.”
IPF is a type of chronic lung condition characterized by a progressive and irreversible decline in lung function and scarring (fibrosis) of the lungs.
Algernon is a Canadian clinical-stage drug development company investigating multiple drugs for unmet global medical needs. Algernon has active research programs for IPF with chronic cough, chronic kidney disease, and a psychedelic program investigating a proprietary form of DMT for stroke.
Algernon Pharmaceuticals Inc. (AGN) is up 17.97 per cent on the day, trading at C$3.02 per share at 10 am ET.
