Algernon Pharmaceuticals announced its plans to conduct a new in vivo animal study comparing its lead anti-fibrotic NP-251 compound with clinically relevant doses of both Esbriet (pirfenidone) and Ofev (nintedanib), two approved medicines for the treatment of idiopathic pulmonary fibrosis (IPF).
IPF is a chronic lung disease characterized by a progressive and irreversible decline in lung function due to fibrosis — the thickening and stiffening of tissue.
Fibrosis is also a major underlying condition in other serious diseases, such as chronic kidney disease (CKD; fibrosis affecting the kidneys), and nonalcoholic steatohepatitis (NASH; fibrosis affecting the liver). Several Algernon compounds have shown successful anti-fibrotic activity in these diseases.
Based on these observations in CKD and NASH, Algernon decided to expand its research program to another fibrotic disease, IPF. The company screened a number of its lead compounds in animal models of IPF, and NP-251 showed the most promise out of eight compounds tested during the early research phase.
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Based on positive preliminary data, the company plans to assess NP-251’s potential therapeutic effects in a new in vivo animal study. The candidate will be compared with two IPF therapies approved by the U.S. Food and Drug Administration (FDA): Esbriet (marketed by Genentech), and Ofev (marketed by Boehringer Ingelheim).
“A successful IPF in vivo study for NP-251 would mean that Algernon could begin planning an additional Phase 2 study for its fourth major global disease,” Christopher J. Moreau, CEO of Algernon Pharmaceuticals, said in a press release. Algernon’s targeted diseases include NASH, CKD, inflammatory bowel disease, and now IPF.
“A potential new treatment for IPF could also mean an orphan drug designation, which could help expedite its availability to patients. We look forward to updating the market on our progress shortly,” Moreau added.
The Orphan Drug Designation program “provides orphan status to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug,” according to FDA criteria.
This designation provides incentives to the treatment’s developer, such as an extended period of exclusivity during which the producer has sole marketing rights.
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