BELLUS Health announced the initiation of healthy subjects dosing in a Phase I clinical study for BLU-5937, its lead drug candidate for the treatment of chronic cough. The main objectives of the Phase I clinical study are to assess the safety, tolerability (including taste perception) and pharmacokinetic profile of BLU-5937 in healthy subjects. This is a randomized, double-blind, placebo-controlled study of orally administered BLU-5937 in up to 90 healthy adult subjects. The study will be divided in two parts. Part 1: A single-ascending dose (“SAD”) study will be conducted in up to 60 healthy subjects. Subjects will be randomized into up to 6 cohorts of 10 subjects (8 BLU-5937: 2 placebo). Part 2: A multiple-ascending dose (“MAD”) study will be conducted in up to 30 healthy subjects. Subjects will be randomized into up to 3 cohorts of 10 subjects (8 BLU-5937: 2 placebo). Each subject will receive daily oral administrations of the assigned treatment for seven consecutive days. The dose regimen for the MAD study will be established based on the SAD study results.
Eisai and Biogen announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease. The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography). The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score (ADCOMS) and on reduction of amyloid accumulated in the brain as measured using amyloid-PET (positron emission tomography). The study is a placebo-controlled, double-blind, parallel-group, randomized study in 856 patients with mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild Alzheimer’s dementia. Patients were randomized to five dose regimens, 2.5 mg/kg biweekly, 5 mg/kg monthly, 5 mg/kg biweekly, 10 mg/kg monthly and 10 mg/kg biweekly, or placebo. BAN2401 demonstrated an acceptable tolerability profile through 18 months of study drug administration. The most common treatment emergent adverse events were infusion-related reactions and Amyloid Related Imaging Abnormalities (ARIA).
Seattle Genetics announced that results of a Phase Ib clinical trial of tucatinib in combination with standard of care agents for the treatment of patients with advanced HER2-positive (HER2+) metastatic breast cancer. Results demonstrated that tucatinib in combination with trastuzumab (Herceptin) and capecitabine (Xeloda) were generally well-tolerated and had encouraging clinical activity in heavily pre-treated patients with advanced HER2+ breast cancer, including those with brain metastases (ONT-380-005/triplet study). This Phase Ib, open-label dose escalation and expansion cohort study of tucatinib in combination with T-DM1 enrolled 57 patients with HER2+ breast cancer. The Phase Ib triplet study was an open-label dose-escalation and expansion cohort study of tucatinib in combination with capecitabine and/or trastuzumab in patients with HER2+ metastatic breast cancer, including those with or without brain metastases. The study results of tucatinib and T-DM1 showed ORR was 47 percent (n=34/50) and the combination of tucatinib and T-DM1 was well-tolerated and the majority of adverse events were grade 1. The objective of the study was to assess the safety, tolerability, pharmacokinetics and antitumor activity, and to determine the recommended Phase II dose of tucatinib in combination with these agents.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced topline results from the Phase III PHOENIX trial evaluating the investigational use of IMBRUVICA (ibrutinib) in the treatment of newly diagnosed non-Germinal Center B cell (non-GCB) subtype of diffuse large B-cell lymphoma (DLBCL), an aggressive form of non-Hodgkin lymphoma (NHL). The study compared IMBRUVICA plus rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) versus R-CHOP, the current standard of care in DLBCL. The primary endpoint was event-free survival, defined as the time interval from randomization to the date of disease progression, relapse from complete response as assessed by the investigator, initiation of systemic anti-lymphoma therapy for either positron emission tomography-positive or biopsy-proven residual disease upon completion of at least six cycles of R-CHOP therapy, or death, whichever occurred first. The clinical trial did not meet the primary endpoint of event-free survival in patients with non-GCB subtype of DLBCL, including activated B cell-like (ABC) subtype of DLBCL. PHOENIX (NCT01855750) is a randomized, double-blind, placebo-controlled, multicenter, Phase III study comparing the efficacy and safety of ibrutinib in combination with R-CHOP versus placebo in combination with R-CHOP in patients with newly diagnosed non-GCB subtype of DLBCL, including ABC subtype of DLBCL. In the study, patients were randomized in a 1:1 ratio to receive either placebo plus R-CHOP or 560 mg ibrutinib plus R-CHOP stratified by Revised International Prognostic Index, geographic region, and number of pre-specified treatment cycles (six vs. eight cycles).