Isotechnika says data show long-term safety and efficacy for psoriasis drug ISA247

By E. Janene Geiss

Philadelphia, Dec. 8 - Isotechnika Inc. announced Thursday that nine-month interim safety and efficacy data for its lead immunosuppressive drug, ISA247, for psoriasis suggest that the drug has long-term safety.

The conclusion was based on its 24-week phase 3 psoriasis trial and 12-week extension.

The goals of the extension trial are to demonstrate continued therapeutic benefit to psoriasis patients and to gather longer term safety and efficacy data, officials said in a news release.

To date, 254 patients have completed 12 weeks of the extension trial for a total 36 weeks of treatment. The data indicates that there are no clinically or statistically significant changes in serum creatinine or glomerular filtration rate over the duration of the trial period, officials said.

Patients completing the 24-week Canadian phase 3 Spirit trial were given the opportunity to continue therapy for an additional 36 weeks or to discontinue therapy. Ninety percent of patients chose to enroll in the extension trial, officials said.

Those patients who chose to enroll in the extension trial were moved from the 0.2 mg/kg (low dose) or 0.4 mg/kg (high dose) twice daily dose groups into the 0.3 mg/kg twice daily (mid-dose group). Patients who started the Spirit trial in the 0.3 mg/kg twice daily dose group remained on the same dosage regimen for the duration of the extension trial, officials said.

As anticipated, the company said the improvement in PASI scores remained fairly stable for those patients previously in the mid-dose group of the Spirit trial. Patients previously in the low-dose group have seen an improvement in mean percent change in PASI scores from 42% to 66% after 12 weeks on the mid dose, officials said.

Patients previously in the high-dose group have seen a slight change in PASI scores from 70% to 61%, officials said.

"Our optimism regarding the efficacy of ISA247 and lack of renal or any other toxicity seen after 24 weeks of therapy is confirmed in the extension study data to date," Gilles Lauzon, director of the division of dermatology at the University of Alberta, said in the release.

Isotechnika is an Edmonton, Alta., biopharmaceutical company focused on the development of immunosuppressive therapeutics that are safer that treatments currently available.

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