Medivir AB (publ) said the phase 2 trial of its remetinostat gel demonstrated efficacy and safety in patients with a type of skin cancer.
According to data from the study, the drug was generally well tolerated and reduced severity of the symptoms in patients with mycosis fungoides type early-stage cutaneous T-cell lymphoma.
The drug was tested for the reductions of skin lesions and itching as a result of the disease. The primary endpoint of the study was the proportion of patients with either a complete or partial confirmed response to therapy.
Based on the results, 40% of the patients that received the 1%-dosage of the treatment twice a day displayed confirmed response, with 25% achieving confirmed in the 0.5% twice daily arm and 20% in the 1% once daily arm.
The secondary objective of the trial was a reduction in the severity of pruritus or itching: 80% of the patients in the 1% twice daily, 50% in the 0.5% twice daily and 37.5% in the 1% once daily arm achieved clinically significant reduction in pruritus.
"Given the chronic nature of this cancer and the limited availability of safe, effective and convenient treatments, patients with early-stage CTCL are in need of new treatment options that effectively control the symptoms of the disease and that are safe to use over long periods for time. The results of the phase 2 study support the progression of remetinostat into a pivotal clinical program," Medivir Chief Medical Officer John Öhd said in a statement.