Invion SLE treatment completes phase 2 with variable results

Invion, Limited announced the completion of a phase 2 trial of its investigational treatment for systemic lupus erythematosus, INV103, with some apparent benefits, particularly with increased dosing, but also variability within the results, according to a press release.

The trial included 28 patients with systemic lupus erythematosus (SLE) randomized to three treatment groups and a placebo group. Patients were monitored for changes to three target cytokines, interleukin- (IL)-1-beta, IL-6 and tumor necrosis factor alpha (TNF-a) in peripheral blood mononuclear cells (PBMCs) at 6 hours after the first and 6 hours after the last dose.

Patients in the first cohort received 10mg INV103 (ala-Cpn10, Invion) through IV twice a week for 4 weeks. No consistent effect was seen in the three target cytokines. Patients in the second cohort received 30mg INV103 twice weekly for 4 weeks and a consistent reduction in the three cytokines was observed. A reduction by 35% was seen with TNF-a, IL-1-beta was reduced by 38.5% and IL-6 was reduced by 42.5%. Six hours after the final dose was administered at week 9, TNF-a was reduced by 62%, IL-1 was down by 66% and IL-6 was 73% lower.

Patients in the third cohort received 100 mg twice weekly for 4 weeks and showed mixed results. One patient had no response but others responded to treatment in a similar manner to the response seen in the second cohort. However, one patient in the placebo group showed a 99% reduction in cytokine production.

The treatment met its safety endpoints, and the Executive Vice President R&D and Chief Medical Officer, Mitchell Glass MD, said in the release that the company plans to move forward with continued testing in larger groups of patients for a longer length of time.

Referenc e: www.inviongroup.com.