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Cytos issued mixed results from a phase IIa trial of CYT-003-QbG10 for the treatment of atopic dermatitis (AD). This randomized, double-blind and placebo-controlled trial enrolled 36 subjects withmild to moderate AD, as assessed by the Eczema Area Severity Index (EASI). Subjectswere randomized to two treatment groups and received 6 weekly subcutaneous injectionsof either 300 micrograms CYT003-QbG10 or placebo. Two weeks after the last dose,the disease status of the patients was again assessed by the EASI. Treatment wassafe and well tolerated. However, both the CYT003-QbG10 and placebo treatmentgroups showed a similar reduction of the EASI scores as measured over the studyperiod, indicating no treatment effect for CYT003-QbG10 in atopic dermatitis atthe dose level tested in this trial. Based on the results, Cytos is planning toconduct trials testing higher dose levels of CYT-003-QbG10 in order to determinea future path for this compound.
Basilea reported positive results from a phase III re-treatment trial of alitretinoin for severe chronic hand eczema. This trial enrolled 117 subjects who eventually had disease recurrence, and 243 subjects who had incomplete response after the initial treatment trial. The trial was designed to evaluate the safety and efficacy of a second treatment course of alitretinoin (30mg or 10mg) in subjects who achieved clear or almost clear hands after a previous initial treatment course. Subjects who had disease recurrence were randomized in double blind manner to receive another 12 to 24 weeks treatment with either placebo or their previous dose of alitretinoin. Response rates were 80% for the alitretinoin 30 mg group versus 8.3% for placebo and 48% for the 10 mg group versus 10% for placebo. The subjects who had either no or an incomplete response received 30 mg alitretinoin in an open-label fashion for another 12 to 24 weeks. The response rate was 47%. Based on these and other phase III results, Basilea plans to file an NDA before the end of 2007.
Connetics has issued positive results of a phase III trial of Desilux (desonide), their low-potency topical steroid in a foam formulation for the treatment of atopic dermatitis (eczema). Data for the drug achieved statistical superiority to placebo in the portion of patients achieving complete or near complete symptom amelioration on the Investigator's Static Global Assessment with no or minimal erythema and induration (39% vs. 8%; p<0.0001). This randomized, blinded, placebo-controlled study enrolled 581 patients, who received the drug or placebo twice daily for 4 weeks, followed by a 3-week observational follow-up. Based on these results, the company announced plans to submit and NDA for Desilux before the end of 2005.
NUCRYST Pharmaceuticals reported mixed results from a phase IIa trial investigating NPI 32101, a topical cream form of silver Rx nanocrystals for the treatment of atopic dermatitis. Results showed that statistical significance was not met, in the intent-to-treat analysis, in the overall investigator assessment of disease improvement. However, statistical significance was achieved with 1.0% NPI 32101 compared to vehicle using intent-to-treat patients who completed six weeks of treatment method. NPI 32101 was well tolerated with no serious adverse events reported. The double-blind, randomized, placebo-controlled study enrolled 224 subjects with mild to moderate atopic dermatitis at 23 sites across the U.S. Subjects were treated twice daily for a six-week period with one of two concentrations of NPI 32101, 0.5% and 1.0%, in a cream formulation or with the vehicle alone. The study was designed to evaluate the safety and efficacy of topical NPI 32101 in improving the signs and symptoms of atopic dermatitis. The company plans initiate additional phase II studies in order to prepare for the larger phase III trials of NPI 32101.
In a 12-month, double-blind controlled trial involving 251 infants (3-23 months old), a treatment regimen with Elidel (pimecrolimus) Cream 1% was compared to the conventional therapy regimen for the treatment of atopic dermatitis (eczema). Results showed that treatment with Elidel significantly reduced the incidence of flares over 6 and 12-month periods. In addition, 56.9% of subjects treated with Elidel experienced no flares over 12 months, while 28.3% of the control group experienced similar improvement during that time. Since topical corticosteroids were permitted in both treatment groups to treat severe flares, the analysis also compared corticosteroid use between the two groups. 63.7% of the Elidel group versus 34.8% of the control group used no corticosteroids. Elidel, which is currently approved for the treatment of eczema in subjects 2 years old and older, was developed by Novartis.
Phase III trial results suggest that Novartis' Elidel (pimecrolimus) cream 1% is more effective than a conventional treatment in reducing the incidence of disease flares. The 12-month, multicenter, double-blind study included 713 pediatric eczema subjects ages two to 17 years. The trial compared a long-term Elidel treatment regimen with a current conventional therapy regimen. Subjects applied either treatment at the earliest signs or symptoms of the disease. Both groups also used topical corticosteroids to treat any severe flares. At both six and 12 months, results showed that Elidel significantly reduced flare incidence compared to the conventional therapy. Additionally, 57% of subjects treated with Elidel had no flares that required corticosteroid treatment, compared to 32% in the control group.