Spherium Biomed announces positive outcome of Cyclatop’s (SP14019) clinical trial showing that the product is safe and efficacious for the treatment of Atopic Dermatitis in adults and infants
Spherium Biomed presented last Saturday at the EADV Congress in Paris the results of the clinical trial Cyclatop (NCT02865356) to investigate the safety, tolerability, pharmacokinetics and efficacy of SP14019 (Cyclosporine A 5% topical spray) across all group ages, for the treatment of mild to moderate atopic dermatitis.
SP14019 showed excellent safety and acceptability profile, clinically relevant and statistically significant efficacy with respect to placebo and very low systemic exposure to Cyclosporine A.
Luis Ruiz-Avila, Spherium Biomed’s CEO, shared that, “SP14019 represents a unique opportunity to extend the well-established benefits of Cyclosporine A in the indication, both in time (allowing for longer treatments) and in the patient base (broadening the scope of treatment to milder cases and pediatric populations). We are confident these results will allow us to find the right partners to make this product available to patients as soon as possible.”
Cyclatop, or SP14019, is based on a proprietary, high-load formulation of Cyclosporine A compatible with cutaneous spray administration capable of delivering appropriate amounts of Cyclosporine to the target layers in the skin. The key aspect of SP14019 development has been obtaining a high-load, skin penetrating, scalable, stable and regulatory compliant topical formulation of CsA.
ABG IP is proud to have collaborated with Spherium Biomed in the IP protection of Cyclatop and other products in the company’s pipeline.