Emoxypine is one of the most commercialized generic medications in Russia and Ukraine for the treatment of several neurological disorders. Its branded form, sold under the name Mexidol, is currently being tested in a Phase 3 trial (NCT02793687) sponsored by Pharmasoft, a Russian pharmaceutical company, for the treatment of ischemic stroke.
Algernon, a pharmaceutical company focused on repurposing generic medications that are not available in the U.S. or E.U., has been investigating if NP-178 could be used to treat Crohn’s disease (CD) and ulcerative colitis (UC). Of note, drug repurposing refers to the process of testing a medication with established safety in conditions other than those for which it was originally intended.
Findings from the company’s two recent preclinical studies, one focused on UC and the other on CD, have shown that NP-178 had strong clinical activity in diseased animals, leading to significant improvements in disease activity, body weight, stool consistency, colon length, and occult positivity (presence of unseen blood in the stool).
Algernon stated that the clinical activity demonstrated by NP-178 in both studies was identical or even superior to that of 5-aminosalicylic (5-ASA), a current standard of care treatment for IBD. Neither study reported any side effects directly related to the use of NP-178.
Moreover, during the UC study, NP-120 (ifenprodil) — Algernon’s repurposed lead candidate to treat idiopathic pulmonary fibrosis (IPF) — showed potent anti-diarrheal properties. This is an important discovery because Esbriet (pirfenidone), one of two globally approved therapies for IPF, often causes severe diarrhea, which reduces treatment compliance.
“We are currently planning an off-label Phase 2 clinical trial for NP-178 (emoxypine),” Christopher J. Moreau, CEO of Algernon, said in a news release. “Pending the results, the company will begin the process for regulatory approval” with the U.S. Food and Drug Administration.
“We also intend to publish our data in a peer-reviewed journal shortly. Patients around the world are suffering from IBD and we believe new effective treatment options would be welcomed by both physicians and patients,” Moreau added.
Meanwhile, Algernon has filed several patent applications to protect the intellectual property rights of NP-178 and NP-120.