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Psoraxine Trial in Psoriasis Fails To Meet Primary Endpoint

FAIRFIELD, N.J., March 14 /PRNewswire-FirstCall/ -- Astralis Ltd. (BULLETIN BOARD: ASTR) today announced that the Phase II study of its novel immuno-stimulatory product for the treatment of Psoriasis did not meet the primary study endpoint upon completion of the treatment phase of the study. In the study, Psoraxine was found to be safe and well tolerated.

The Phase II randomized, double-blind, placebo-controlled study involved 120 patients with moderate to severe psoriasis who received intramuscular injections of Psoraxine. The primary endpoint of the study was a specified level of improvement of symptoms as measured in accordance with the Psoriasis Area and Severity Index (PASI), a measurement scale that ranks the severity of symptoms of patients suffering from psoriasis. Initial analysis of the preliminary data showed no statistically significant clinical improvement compared to placebo following six injections over twelve weeks of treatment.

"We are currently analyzing the data to understand why this study differs from the long-term improvement of the more than 2700 patients who were treated previously in Venezuela," said Jose O'Daly, M.D., Ph.D., Chief Scientific Officer and Chairman of the Board of Astralis. "We are committed to understanding whether a different approach, including evaluating a longer course of therapy and/or modifications to the formulation may yield an outcome that is more consistent with the results we have seen with patients treated in Venezuela."

CEO, James Sharpe noted that, "Although we are disappointed by our preliminary results, we remain committed to Psoraxine and its future clinical development. We also remain committed to the use of our technology platform in other dermatological diseases, as well as in other therapeutic areas including arthritis."

Further details about the trial will be available when all data analyses are complete.

Source: Astralis Ltd.

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