Galderma announced positive results from OSCAR, a Phase IV trial, multicenter, randomized, investigator-blinded, vehicle-controlled, intra-individual comparison study (right/left half-face). The purpose of OSCAR was to evaluate the efficacy of Epiduo Forte (adapalene and benzoyl peroxide) Gel, 0.3 percent/2.5 percent in the treatment of moderate-to-severe acne and to understand if, by decreasing active acne lesions, Epiduo Forte Gel could thereby decrease the risk of atrophic (depressed) acne scars. Results demonstrated Epiduo Forte Gel significantly decreased acne lesions, as measured over a period of 24 weeks vs. vehicle (P < .0001), with acne lesion reduction as early as week one. Subjects received 24 weeks of treatment with Epiduo Forte Gel or vehicle (half-face) and full-face skin care. At 24 weeks, based on satisfactory investigator-assessed efficacy and subject agreement, subjects could be treated with once-daily Epiduo Forte Gel on the full face for up to 24 additional weeks with two additional visits at weeks 36 and 48. According to a patient satisfaction survey, overall, 90.1 percent were satisfied to very satisfied with Epiduo Forte Gel vs. 59 percent with vehicle.
Allergan announced positive results from ACHIEVE II (UBR-MD-02), the second of two pivotal Phase III clinical trials evaluating the efficacy, safety and tolerability of orally administered ubrogepant 25 mg and ubrogepant 50 mg compared to placebo in a single migraine attack in adults. The ACHIEVE II study included 1,686 U.S. adult patients randomized (1:1:1) to placebo, ubrogepant 25 mg and 50 mg respectively, to treat a single migraine attack of moderate-to-severe headache intensity. In the modified ITT (mITT) population of 1,355 patients, 18 to 75 years of age with a history of migraine, both doses showed a statistically significant greater percentage of ubrogepant patients achieving pain freedom at two hours after the initial dose as compared to placebo patients (25 mg vs placebo, p=0.0285, 50 mg vs placebo, p=0.0129). The ACHIEVE II trial is a Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the efficacy, safety and tolerability of two doses of ubrogepant (25 mg and 50 mg) compared to placebo for the treatment of a single migraine attack.
Rigel Pharmaceuticals announced positive results from the Fostamatinib in Thrombocytopenia (FIT) Phase III clinical program of TAVALISSE (fostamatinib disodium hexahydrate) for the treatment of adults with chronic immune thrombocytopenia (ITP). FIT-1 and FIT-2 were randomized, double-blind, placebo-controlled Phase III trials evaluating TAVALISSE, an oral spleen tyrosine kinase (SYK) inhibitor, in comparison with placebo in a total of 150 adult patients with persistent or (predominantly) chronic ITP. The studies were designed in accordance with FDA guidance and the efficacy endpoints were based on an objective laboratory assessment of platelet count. Patients who completed the 24-week study treatment in either FIT-1 or FIT-2 could enroll in the long-term, open-label extension study (FIT-3). These Phase III studies were the first to evaluate second- or third-line treatment for ITP in the current era of widespread use of TPO-RA and rituximab.
Galapagos and MorphoSys announced that the first patient has been screened in IGUANA, a Phase II study with MOR106, an investigational antibody directed against IL-17C, in atopic dermatitis patients. At least 180 patients with moderate-to-severe atopic dermatitis (AD) are planned to be treated over a 12- week period with one of three different doses of MOR106 (1, 3 or 10 mg/kg) or placebo using two different dosing regimens in this Phase II trial in multiple centers across Europe. The placebo-controlled, double-blind study will evaluate the efficacy, safety and pharmacokinetics (PK) of MOR106. Dosing at two- or four-week intervals will be evaluated over the 12-week treatment period, followed by a 16-week observation period. The primary objective will be assessed by the percentage change from baseline in Eczema Area and Severity Index (EASI) score at week 12.