Kala Pharmaceuticals, Inc. Announces Topline Results for Two Phase 3 Trials
January 05, 2018 at 07:00 am
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Kala Pharmaceuticals, Inc. announced topline results from its two Phase 3 clinical trials, STRIDE 1 and STRIDE 2 (STRIDE - Short Term Relief In Dry Eye), evaluating the safety and efficacy of KPI-121 0.25% versus placebo in patients with dry eye disease. In the STRIDE 1 trial, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia change from baseline to day 15 in the ITT population (p<0.0001) and the primary symptom endpoint of ocular discomfort severity change from baseline to day 15 in the ITT population (p<0.0001). Statistical significance was also achieved for a second pre-specified primary symptom endpoint of ocular discomfort severity change from baseline to day 15 in patients with more severe baseline ocular discomfort (p=0.0008). Statistical significance was not achieved for a second pre-specified primary sign endpoint, inferior corneal staining change from baseline to day 15 (p=0.1128). A positive treatment effect for ocular discomfort was also observed in the ITT population at day 8 (p=0.0011). KPI-121 was well tolerated in this trial with the most common adverse event in STRIDE 1 being instillation site pain, which was observed in 6.1% of patients in both the KPI-121 treatment group and the placebo group. The only other adverse event reported by greater than 1% of patients was eye irritation, which was reported in 1.1% of patients on KPI-121 vs. 1.5% of patients on placebo. Elevations in IOP, a known side effect with topical corticosteroid dministration, were similar between the two groups with 0.4% in the KPI-121 group experiencing an increase in IOP of 5 mm of mercury (mmHg) or greater resulting in an IOP of 21 mmHg or greater compared to 0.4% in the placebo group. In the STRIDE 2 trial, statistical significance was achieved for the primary sign endpoint of conjunctival hyperemia change from baseline to day 15 in the ITT population (p<0.0001). Statistical significance was not achieved for the primary symptom endpoint of ocular discomfort severity change from baseline to day 15 in the ITT population (p=0.1298), although a positive treatment effect was observed at day 8 (p=0.0408), a key secondary endpoint. A trend towards a positive treatment effect was observed for ocular discomfort severity change from baseline to day 15 in the patients with more severe baseline ocular discomfort (p=0.0799), which was a key secondary endpoint in this trial. KPI-121 was well tolerated in this trial with instillation pain being the most common adverse event In STRIDE 2 as reported by 5.7% of patients in the KPI-121 treatment group vs. 4.4% in the placebo group. The only other adverse event reported by greater than 1% of patients was blurred vision, which was reported in 0.2% of patients on KPI-121 vs. 1.3% of patients on placebo. Elevations in IOP were similar between the two groups with 1.1% in the KPI-121 group experiencing an increase in IOP of 5 mmHg or greater resulting in an IOP of 21 mmHg or greater compared to none in the placebo group.
KALA BIO, Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in the research, development and commercialization of therapies for rare and severe diseases of the eye. The Companyâs biologics-based investigational therapies utilize its proprietary mesenchymal stem cell secretome (MSC-S) platform. The Companyâs product candidate, KPI-012, is a human MSC-S, which contains numerous human-derived bio factors, such as growth factors, protease inhibitors, matrix proteins and neurotrophic factors that can potentially correct the impaired corneal healing that is an underlying etiology of multiple severe ocular diseases. Its KPI-012 is used for the treatment of persistent corneal epithelial defect (PCED), a rare disease of impaired corneal healing. The Company is also engaged in the development of KPI-012 for the treatment of Limbal Stem Cell Deficiency and other rare corneal diseases.
KALA BIO, INC. 
