Kala Pharmaceuticals Announces Topline Results for Two Phase 3 Trials (STRIDE 1 and STRIDE 2) of KPI-121 0.25% in Dry Eye Disease
- Statistical significance achieved for the primary sign endpoint, conjunctival hyperemia at Day 15 in the ITT population, in STRIDE 1 (p<0.0001)
- Statistical significance achieved for the primary sign endpoint, conjunctival hyperemia at Day 15 in the ITT population, in STRIDE 2 (p<0.0001)
- Statistical significance achieved for the primary symptom endpoint, ocular discomfort severity at Day 15 in the ITT population, in STRIDE 1 (p<0.0001)
- Ocular discomfort severity at Day 15 in the ITT population showed improvement but did not reach statistical significance in STRIDE 2 (p=0.1298)
- Statistical significance for ocular discomfort severity at Day 15 in patients with more severe baseline discomfort was achieved in STRIDE 1 (p=0.0008), with a trend towards a treatment effect (p=0.0799) in STRIDE 2
- Positive treatment effects observed for ocular discomfort severity in the ITT population at Day 8, a key secondary endpoint in both STRIDE 1 (p=0.0011) and STRIDE 2 (p=0.0408)
- KPI-121 0.25% was well-tolerated with elevations in IOP similar to placebo
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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 administration, 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.
“We are pleased with the positive topline results of STRIDE 1, in which
KPI-121 demonstrated statistically significant improvements in primary
sign and symptom endpoints and are encouraged with the results in STRIDE
2, which showed statistical significance for the primary sign endpoint.
Although we did not achieve statistical significance for the primary
symptom endpoint in STRIDE 2, we did observe a strong trend towards a
positive treatment effect in symptoms in more symptomatic patients, for
which we achieved statistical significance in STRIDE 1,” said
The two Phase 3 clinical trials were each multicenter, randomized, double-masked, placebo controlled, parallel-arm studies comparing KPI-121 to placebo each dosed four times a day (QID) for 14 days. Subjects who met initial screening and inclusion/exclusion criteria underwent a 2-week run-in period with placebo dosed in each eye QID for 14 days. Subjects who continued to meet inclusion and exclusion criteria after the run-in were randomized to either KPI-121 or placebo. A total of 918 patients were randomized in STRIDE 1 and 909 patients were randomized in STRIDE 2. Ocular discomfort severity was graded daily by the patient over the entire course of the trial using a visual analog grading scale recorded in a patient diary.
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About Dry Eye Disease
Dry eye disease is a chronic, episodic, multifactorial disease affecting
the tears and ocular surface that can result in tear film instability,
inflammation, discomfort, visual disturbance and ocular surface damage.
Dry eye disease is estimated to affect approximately 33 million people
in
About KPI-121 0.25%
Kala is developing KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease utilizing a two-week course of therapy administered four times a day. Dry eye disease is a chronic, episodic, multifactorial disease affecting the tears and ocular surface that can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage. KPI-121 0.25% utilizes Kala’s MPP technology to enhance penetration of loteprednol etabonate (LE) into target tissue of the eye. In preclinical studies, MPP technology increased delivery of LE into ocular tissues more than three-fold compared to current LE products by facilitating penetration through the tear film mucus. Kala believes that KPI-121 0.25%’s broad mechanism of action, rapid onset of relief of both signs and symptoms, favorable tolerability and safety profile and potential to be complementary to existing therapies, could result in a favorable profile for the management of dry eye flares and other dry eye associated conditions that would benefit from temporary relief of dry eye signs and symptoms.
About Kala Pharmaceuticals, Inc.
Kala is a biopharmaceutical company focused on the development and commercialization of therapeutics using its proprietary mucus-penetrating particle (MPP) technology, with an initial focus on the treatment of eye diseases. Kala has applied the MPP technology to a corticosteroid designed for ocular applications, resulting in two lead product candidates. The product candidates are INVELTYSTM (KPI-121 1%) for the treatment of inflammation and pain following ocular surgery, for which we have submitted a NDA, and KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease.
Forward Looking Statements
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995, that
involve substantial risks and uncertainties including statements
regarding the development and regulatory status of the company's product
candidates, including INVELTYSTM (KPI-121 1%) for the
treatment of inflammation and pain following ocular surgery and KPI-121
0.25% for the temporary relief of the signs and symptoms of dry eye
disease. All statements, other than statements of historical facts,
contained in this press release, including statements regarding the
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are forward-looking statements. The words “anticipate,” “believe,”
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and you should not place undue reliance on such forward-looking
statements. Actual results or events could differ materially from the
plans, intentions and expectations disclosed in the forward-looking
statements as a result of various risks and uncertainties including, but
not limited to: whether the data from our Phase 3 clinical trials of
KPI-121 0.25% will warrant submission of an NDA on the timeline
expected, or at all, whether any additional clinical trials will be
required prior to submission of an NDA and whether any such NDA will be
approved; that topline data is based on preliminary analysis of key
efficacy and safety data, and such data could change following a more
comprehensive review and may not accurately reflect the complete results
of our clinical trials; whether our NDA for INVELTYS will be approved by
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timing of data from ongoing clinical trials; expectations for regulatory
approvals to conduct trials or to market products; whether the Company’s
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unforeseeable operating expenses and capital expenditure requirements;
the risk that our audited financial results for the year ended
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