Algernon Pharmaceuticals Inc., a Canadian clinical-stage pharmaceutical development company, announced today that it has received a notice of allowance from the European Patent Office (EPO) for its lead chronic kidney disease (CKD) drug candidate, NP-251 (Repirinast).
The patent (application 19827430.0) covers the use of Repirinast, either alone or in combination with telmisartan, for the treatment or prevention of renal fibrosis or kidney disease. This European patent protection will extend through 2038, not including any potential term adjustments or extensions that could provide additional market exclusivity.
"This is our first patent issued by the EPO and marks another key milestone for the Company," said Christopher J. Moreau, CEO of Algernon Pharmaceuticals.
Strategic Patent Portfolio Expansion
The European patent adds to Algernon's growing intellectual property portfolio for Repirinast, with similar patents already allowed in the United States, Japan, and China. A patent application remains pending in Canada.
This systematic approach to global patent protection aligns with Algernon's broader intellectual property strategy for its repurposed drug program, which includes filing patent applications covering methods of use, dosing regimens, formulations, and novel salt forms.
Promising Preclinical Data
Repirinast has shown significant promise in preclinical studies as a treatment for chronic kidney disease. In a unilateral ureteral obstruction (UUO) mouse model, the compound reduced fibrosis by 51% with statistical significance. Importantly, it demonstrated an additive benefit when used in combination with telmisartan, a widely prescribed angiotensin II receptor blocker used to treat hypertension and kidney disease.
Mechanism of Action
The drug's effectiveness in kidney disease appears to stem from its ability to prevent mast cell degranulation. Mast cells, which are recruited to sites of cellular damage, release proinflammatory chemical mediators when they degranulate. This process can trigger a self-propagating cascade of tissue damage.
NP-251 binds to receptors on mast cells and prevents their degranulation, potentially blocking this inflammatory cascade and helping to prevent fibrosis not only in the kidneys but potentially in other organs as well.
Drug Repurposing Background
Repirinast was originally developed by Mitsubishi Tanabe Pharma and marketed in Japan under the brand name Romet™ for asthma treatment. The drug had a 25-year history of clinical use in Japan before Mitsubishi discontinued its manufacturing and sales in 2013.
To support its development program, Algernon has contracted with Zhejiang Ausun Pharmaceutical in China to manufacture a cGMP-compliant supply of Repirinast.
Chronic Kidney Disease: A Global Health Burden
Chronic kidney disease affects approximately 10% of the global population and is characterized by the progressive loss of kidney function over time. Renal fibrosis, the scarring of kidney tissue, is a hallmark of CKD progression and a major contributor to kidney failure.
Current treatment options for CKD are limited and primarily focus on managing symptoms and slowing disease progression rather than addressing the underlying fibrotic processes. The development of antifibrotic therapies like Repirinast represents a potentially significant advance in CKD management.
Company Pipeline
Beyond its CKD program, Algernon Pharmaceuticals is investigating multiple drug candidates for unmet global medical needs. The company is also advancing a psychedelic research program through its private subsidiary, Algernon NeuroScience, which is investigating a proprietary form of DMT for stroke and traumatic brain injury treatment.
As Algernon continues to build its patent portfolio and advance its development programs, the company is positioning itself to address significant unmet needs in kidney disease treatment, potentially offering new options for patients with limited therapeutic alternatives.
