Astralis Reports Phase II Results of Psoraxine Trial
Astralis has reported the results of its 120-patient, 11-site, multidose Phase II clinical trial of Psoraxine, its product for the treatment of psoriasis.
The report presents both Psoriasis Area Severity Index (PASI) and patient biopsy results, respectively the primary and secondary endpoints of the trial. Although the six-injection, 20-week trial of Psoraxine did not demonstrate a statistically significant clinical improvement in PASI scores compared to placebo, the trial again confirmed the safety of the product for human use.
Upon more detailed analysis of both PASI and biopsy results, the company has observed specific data that has led it to conclude that the product is active, although not at the level it expected.
Following analysis of the clinical trial design, manufacturing process and product formulation data, Astralis has identified several factors, including the limited number of injections used and the formulation of the active components of the product, that may have contributed to the unexpected results of the Phase II trial.
Based on these analyses, the company remains committed to the development of Psoraxine, and is embarking on a program to improve the performance of its treatment for psoriasis.