Algernon Pharmaceuticals has announced its plans to launch its first Phase 2 clinical trial evaluating one of two repurposed compounds — NP-120 for the treatment of idiopathic pulmonary fibrosis (IPF) or NP-178 for inflammatory bowel disease (IBD) — in the second quarter of 2020.
This follows the recently announced conclusion of the Canadian company’s funding process, which raised approximately CDN $2.1 million (US $1.6 million). The new funding will allow the launch of the first Phase 2 study, in addition to the planning of other Phase 2 trials and the financing of further research.
A Vancouver-based clinical-stage pharmaceutical company, Algernon is focused on repurposing safe, approved medications that are not available in the U.S. or European Union to treat conditions other than those for which they were originally developed.
The company currently is focused on the development of four approved medications that it has identified as potential repurposed therapies for IPF, inflammatory bowel disease, non-alcoholic steatohepatitis, and chronic kidney disease.
NP-120, Algernon’s lead candidate for treating IPF, is the company’s name for ifenprodil, an oral small molecule originally developed by Sanofi to treat blood circulation disorders. It was sold under the brand name Cerocral in France and Japan. While it is no longer available in France, generic versions of the medication are still sold in Japan.
Previous preclinical studies showed that NP-120 prevented lung tissue scarring, or fibrosis, in a mouse model of IPF to a greater extent than two globally approved IPF therapies — Boehringer Ingelheim’s Ofev (nintedanib), and Genentech’s Esbriet (pirfenidone).
Mice receiving NP-120 had 56% less scar tissue than untreated mice. In comparison, mice treated with Ofev had a 51% reduction in the amount of scar tissue, while those given Esbriet had 44% less scar tissue.
Since NP-120 already has an established safety profile, Algernon plans to move the therapy directly to a Phase 2 clinical trial to evaluate its effectiveness in people with IPF. The company is currently conducting further studies on NP-120’s mechanism of action to identify biomarkers of its effects, which will be used in this future Phase 2 study.
Algernon announced that its first Phase 2 study — which will evaluate NP-120 or NP-178 — is in its final planning stages, and is expected to start in the second quarter of 2020.
According to a press release, the company plans to provide more information on the trial soon, including the compound and disease being studied, who will conduct the study and where, and the trial’s estimated end date. In addition, the company will provide information on whether it will synthesize the compound or use the current compound source. Algernon also will announce when the first patient is enrolled, and any new additions to its medical advisory board.
In the event that Algernon goes forward with a Phase 2 trial on NP-120, it will submit the therapy for orphan drug designation by the U.S. Food and Drug Administration (FDA). That designation would accelerate NP-120’s clinical development and review, and ensure marketing exclusivity for seven years upon regulatory approval.
Before submitting an investigational new drug (IND) application for NP-120, the company plans to request a pre-IND meeting with the FDA, which may help accelerate the approval process. Moreover, if the company decides to synthesize NP-120 instead of using the already available compound, it may be able to use the data from the planned Phase 2 study as part of a future FDA new drug application.
Algernon is set to present data at the 12th Annual LD Micro Main Event Conference, which will be held Dec. 10-12 in Los Angeles.