Actelion recently announced its commitment to accelerate clinical development efforts concerning immunological disorders following a broad medical, scientific and commercial assessment of a series of its selective S1P1 receptor modulators, discovered in-house. The company believes that this effort will lead to new approaches addressing systemic lupus erythematosus.
A second selective S1P1 receptor modulator will be further tested in a Phase II clinical trial in individuals suffering with systemic lupus erythematosus, while the company will also start a Phase II study for ponesimod to address patients with chronic graft versus host disease.
Jean-Paul Clozel, who is the Actelion’s Chief Executive Officer said in a press release: “Our efforts in the field of immunology have reached the necessary maturity to warrant fully-fledged clinical investigation. We have a thorough understanding of what selective S1P1 receptor modulators can bring to the clinic and have matched our compounds with the appropriate indication. We have carried out extensive groundwork and benefited from Health Authority input to design the optimal clinical program, which balances clinical risk, investment, medical need and commercial opportunity.”
“Our ongoing success in the field of PAH [polycyclic aromatic hydrocarbon] is enabling us to pursue the second element of our strategy and take action now to build an additional specialty franchise in the field of immunology. Our confidence in our portfolio means we can take this step while maintaining our commitment to optimize profitability,” he added.
The company will begin a Phase II, multicenter, prospective, randomized, multinational, placebo-controlled, double-blind, dose-response assessment to clear the biological activity, tolerability and safety of Actelion’s second S1P1 receptor modulator in adults suffering with systemic lupus erythematosus. A total of 64 patients will be enrolled in the study and will receive for a 12 weeks period either 0.5, 1, 2 or 4 mg/day of the second S1P1 receptor modulator. The evaluation is expected to last 20 months and it will be conducted at 20 different sites.
Read More Recent News Concerning Systemic Lupus Erythematosus
Several research teams at the New York University School of Medicine – Langone Medical Center recently presented their latest discoveries on key clinical aspects of Systemic Lupus Erythematosus at the NYU Seminar in Advanced Rheumatology. Researchers presented their preliminary findings on how Hydroxychloroquine, an anti-malarial drug, can be used to prevent congenital heart block in children born from women with systemic lupus erythematosus.