Clinical Catch-Up: February 10-14
It was a very busy week for clinical trial news. Here’s a look.
Kodiak Sciences announced positive safety, efficacy and durability data from its ongoing Phase Ib trial of KSI-301 in wet age-related macular degeneration (AMD), diabetic macular edema (DME) and retinal vein occlusion (RVO). KSI-301 is an intravitreal anti-VEGF antibody biopolymer conjugate. They describe the data as promising with 420 doses in 130 patients.
vTv Therapeutics announced positive data from Part 2 of the Phase II Simplici-T1 trial of TTP399 in type 1 diabetes. TTP399 is a novel, liver-selective glucokinase activator. The 12-week trial studied the efficacy and safety of 800 mg of TTP399 compared to placebo in 85 people with type 1 diabetes on optimized insulin therapy. It hit its primary objective, demonstrating statistically significant improvements in HbA1c compared to placebo.
Regeneron Pharmaceuticals announced positive two-year results from the Phase III PANORAMA trial of Eylea (aflibercept) in moderately severe to severe non-proliferative diabetic retinopathy (NPDR). The data showed that untreated moderately severe and severe NPDR can lead to vision-threatening events, and Eylea was shown to reduce the likelihood of these events by at least 75% compared to more than half of the patients (58%) in the untreated sham arm developed a VTC or center-involved diabetic macular edema (CI-DME) within two years.
Roche’s Genentech and Eli Lilly’s different drugs failed the same Alzheimer’s clinical trial. DIAN-TU-001 is a Phase II/III trial that tested two therapies compared to placebo, Genentech and Roche’s gantenerumab and Eli Lilly and Company’s solanezumab.
The overall trial was founded in 2010 and funded by Eli Lilly and Company, Roche and Genentech, the National Institutes of Health, and other donors. The trial was sponsored by Washington University School of Medicine in St. Louis. Genentech announced that the gantenerumab arm of the Phase II/III DIAN-TU-001 trial did not meet the primary endpoint in an early-onset, inherited form of Alzheimer’s. This form of Alzheimer’s is known as autosomal dominant AD (ADAD) and makes up less than 1% of cases. Eli Lilly and Company’s solanezumab also failed to meet the primary endpoint. Solanezumab is also an antibody against amyloid.
Oculis reported positive data from a Phase II trial of OCS-01 for diabetic macular edema (DME). OCS-01 is a novel eye drop formulation of dexamethasone, developed using the company’s Soluble NanoParticle technology. The trial met its efficacy endpoints, showing that OCS-01 was more effective than vehicle in reducing central macular thickness and improving visual acuity.
Myovant announced its Phase III LIBERTY open-label extension study of relugolix combination therapy for uterine fibroids was positive. The drug is a combination of relugolix, estradiol and norethindrone acetate. It showed an 87.7% response rate at one year while maintaining bone mineral density. It expects to include the data in its NDA for heavy menstrual bleeding associated with uterine fibroids expected in April 2020.
Alkahest launched a Phase IIb trial of AKST4290 in treatment native wet age-related macular degeneration. AKST4290 is a small molecule CCR3 inhibitor that can be dosed orally. The company dosed the first patient, which will determine the effects of the drug on visual acuity.
Written by: Mark Terry
Published on: Feb 17, 2020
https://www.biospace.com/article/clinical-catch-up-february-10-14/