Atlantic Healthcare has initiated the rolling submission of New Drug Application (NDA) with the US Food and Drug Administration (FDA) and filed its non-clinical data package for alicaforsen to treat pouchitis.
Pouchitis is a rare inflammatory bowel disease (IBD) with limited treatment options.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
The FDA and European Medicines Agency (EMA) previously awarded Orphan Drug designation to Alicaforsen enema.
It has also received FDA fast-track designation, which recognises the unmet medical need for this disease.
Atlantic Healthcare CEO Toby Wilson Waterworth said: “The filing of the non-clinical data package initiates the regulatory process for obtaining marketing approval for alicaforsen in the treatment of pouchitis.
“This is a significant milestone in our corporate development.
US Tariffs are shifting - will you react or anticipate?
Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis.
By GlobalData“As an anti-sense therapy, alicaforsen enema has the potential to be first to market in a new class of drugs for the treatment of IBD.
“Alicaforsen also has the potential to treat multiple inflammatory diseases of the GI tract and elsewhere. Atlantic Healthcare is currently exploring additional formulations to extend the use of alicaforsen into other IBD indications.”
The Phase III trial, in which the enema formulation is currently underway in patients with active, chronic pouchitis, agreed with the US, Canadian and European regulatory agencies.
The company is also preparing to start a pivotal Phase IIIstudy for active distal ulcerative colitis (UC).
The Phase II trials involved 377 patients and showed that Alicaforsen enema reduced inflammation and promoted mucosal healing with good tolerability and a durable effect.
Alicaforsen enema is an anti-sense oligonucleotide that interacts with mRNA for ICAM-1, a cell-surface protein involved in the inflammatory response of both the adaptive and innate components of the immune system.
Atlantic Healthcare also claimed that alicaforsen can also interact with TLR-9, an intracellular receptor also involved in inflammatory responses.
