Avexxin's lead compound AVX001 in a topical formulation has shown Proof-of-Concept in man in an ascending dose Phase I/IIa study encompassing 26 patients suffering from mild-to-moderate psoriasis.
The independent Safety Board concluded that the treatment was safe for the patients at the dose levels employed. Max Tolerated Dose was not identified during the study.
Avexxin AS, a therapeutic company focusing on the discovery and development of novel small molecule therapeutics for patients suffering from chronic inflammatory conditions, announces the completion of a second phase I/IIa study showing Proof-of-Concept in man. The trial is a follow-on study to a first Phase I/IIa study completed in 2014, enrolling 26 patients. Functioning as their own placebo, all patients were subjected to a four-week topical treatment followed by a two-week post-monitoring period.
Originally spun off from basic research conducted at the Norwegian University of Science and Technologies by Professor Berit Johansen, Avexxin has several individual compounds and runs drug discovery and pre-clinical development programs. In addition to topical psoriasis, the company also has systemic programs against rheumatoid arthritis and glomerulonephritis, along with certain difficult-to-treat cancers, such as triple-negative basal-like breast cancer.
Avexxin's compounds all target the group IVα phospholipase A2 (GIVαPLA2) enzyme, which regulates cytokine-induced activation of the pro-inflammatory transcription factor nuclear factor-κB (NF-κB). This target has proven to play an important role in many chronic inflammatory disorders. Based on current data, Avexxin is offering a new and broadly applicable therapeutic paradigm with less adverse effects compared to today's treatments, yet with the same efficiency as today's widely used therapeutics. The therapeutic benefits seen with Avexxin inhibitors come about through a Mode of Action, which is disease modifying rather than symptom focused.
Mikael Oerum, Chairman & CEO: "The company's phase I/IIa trial is the culmination of Avexxin's original therapeutic strategy to target early Proof-of-Concept in man in a chronic inflammatory disorder with a large unmet need. Mild-to-moderate psoriasis counts for almost 90% of all psoriasis patients, and many sufferers shy away from today's treatment options because of the side effects or lack of effect with today's treatment options.
"Throughout our preclinical programs, and as now demonstrated by our clinical data, we generally experience an early effect on the disease. More importantly, judging from preclinical data, our compounds appear to be disease modifying and not only treating symptoms.
"Together, Avexxin's combination of several compounds and their target represents a novel platform for broad therapeutic intervention within chronic inflammatory disorders and certain difficult-to-treat cancers, where the intervention point has shown to play an important role. To exploit the full potential of the platform, Avexxin is looking for companies to take the platform forward to market."
"We have seen effects that reach the levels of statistical significance in patients with Psoriasis along with a clean safety profile," says Peter Damsbo, Chief Medical Officer. "In this double-blinded safety study performed in 26 patients, we were pleased to see a clear effect over placebo leading to reduction in the psoriasis score. More specifically, it was the reduction in thickness of the psoriasis plaques that reached statistical significance, an effect appearing after 1-2 weeks. The placebo adjusted effect continued to increase throughout the treatment period indicating a potentially higher effectiveness could be reached by extending the exposure time."