Relative high and frequent dose (150 mg TIW), but data are comparable to other anti-TNF. No antibody? What is t 1/2. Cmax?
Does IMNX (AMGN) has IPR on this molecule/target?
Miljenko
Serono Announces Positive Results For Onercept in Psoriasis and Psoriatic Arthritis In Phase II Trials
Sunday June 22, 8:30 am ET
Phase III in Psoriasis to Be Initiated Later This Year
GENEVA, June 22 /PRNewswire-FirstCall/ -- Serono S.A. (virt-x: SEO and NYSE: SRA) Serono today announced positive Phase II results for onercept (r-hTBP-1) in both psoriasis and psoriatic arthritis. Onercept is a recombinant, unmodified, fully human soluble type I TNF receptor (p55), which acts as an anti TNF agent. The data were presented at the 9th International Psoriasis Symposium in New York.
In a multi-center double-blind placebo-controlled study for psoriasis, patients treated with onercept at a dose of 150mg, subcutaneously, three times a week for a period of 12 weeks, showed a significant improvement in their Psoriasis Area and Severity Index (PASI) score. PASI is the globally accepted measure of treatment efficacy in this indication.
After 12 weeks of therapy, 54% (23/43) of patients receiving onercept 150mg demonstrated 75 percent or greater PASI score improvement (PASI 75) versus 12% (5/43) of patients on placebo (p<0.001). In addition, 74% (32/43) achieved 50 percent or greater PASI score improvement (PASI 50), versus 26% (11/43) in the placebo group (p<0.001). In the study, patients treated with onercept showed significant improvement in PASI after two weeks of treatment compared with placebo (p<0.05). Side effects for onercept-treated patients were similar to those observed in the placebo group. Injection site reactions were more frequent in the onercept group.
Over the 12-week treatment period patients treated with onercept 150mg experienced a significant improvement in quality of life, based on the standard measurements of Short Form 36 (SF-36) and Dermatology Life Quality Index (DLQI).
In an earlier multi-center double-blind placebo-controlled study of onercept in psoriatic arthritis, doses of 50mg and 100mg were given subcutaneously three times a week for a period of 12 weeks. The improvement in the psoriatic arthritis response criteria (PsARC) was more favorable at the 100mg dose. After 12 weeks of treatment at 100mg, 86% (36/42) of patients on onercept met the PsARC primary endpoint compared with 45% (19/42) on placebo (p<0.001). The secondary endpoint of ACR20 was achieved by 67% (28/42) of onercept patients compared to 31% (13/42) on placebo (p=0.001). Side effects for onercept-treated patients were similar to those observed in the placebo group. Injection site reactions were more frequent in the onercept groups.
"Onercept's efficacy and safety data from these studies are very encouraging for people with psoriasis and psoriatic arthritis," said Franck Latrille, Serono's Senior Executive Vice President Global Product Development. "As a result of these positive data we plan to initiate Phase III with onercept in psoriasis later this year."
Additional Study Details
Onercept in Psoriasis
In the 12-week, multicenter double-blind placebo controlled study for psoriasis, 130 patients were treated with either placebo (n=43), 150mg three times a week (n=43) or 100mg seven times a week (n=44). The study included patients with moderate-to-severe psoriasis, which was defined as a baseline PASI of 12 or more and body surface involvement of 10% or more. The primary endpoint was the percentage of patients achieving a PASI 75 response at week 12. Onercept was generally well-tolerated. The most common adverse events (occurring in more than 5% of patients) in patients receiving onercept at 150mg tiw were comparable to those observed in the placebo group. Injection site reactions were more frequent in onercept treated patients. One serious adverse event (hemorrhage in an ovarian cyst) was reported. Rate of infections was similar between the placebo and onercept groups. In addition to the significant improvement in PASI, a Clear or Almost Clear rating in the Physician Global Assessment was achieved in 52% of patients treated with onercept 150 mg three times a week compared to 12% in patients treated with placebo (p<0.001). Patients on onercept also had a mean percentage improvement in SF-36 of 29% compared to 7% in placebo (p<0.05) and a mean percentage improvement in DLQI of 30% against 2% in placebo (p<0.001).
Onercept in Psoriatic Arthritis
The 12-week, multicenter double-blind placebo controlled trial for psoriatic arthritis included 126 patients divided between placebo (n=42), onercept at 50mg three times a week (n=42), and onercept at 100mg three times a week (n=42). At baseline, patients were required to have a PASI of 8 or more, a body surface involvement of 5% or more, and at least three active joints. The primary articular endpoint was the percentage of patients achieving a PsARC response at the end of the 12-week treatment period. Onercept was generally well-tolerated. The most common adverse events (occurring in more than 5% of patients) in patients receiving onercept were comparable to those observed in the placebo group. Injection site reactions were more frequent in the onercept-treated groups. Two serious adverse events (hypokalemia and angle closure glaucoma) were reported at the 50mg dose. Rate of infections was similar between the placebo and onercept groups |
