Kala Pharmaceuticals Announces Update to KPI-121 0.25% Development Plan
– Expects to submit NDA for KPI-121 0.25% in the second half of 2018 –
– Expects to initiate Phase 3 STRIDE 3 trial in the third quarter of 2018 –
The Company announced that it plans to submit a New Drug Application
(NDA) to the
In addition, based upon the recommendation of the
The Company has conducted a comprehensive analysis of data generated in its previous three clinical trials and believes it has identified key factors that contributed to the differences observed in the results from STRIDE 2 compared to those of STRIDE 1 and Phase 2. The Company has integrated these factors into the trial design of STRIDE 3, which the Company believes will improve the probability of success for the trial.
Kala remains committed to developing KPI-121 0.25% for the millions of patients suffering from dry eye disease for whom there is currently no product approved for the temporary relief of signs and symptoms of the disease.
Kala also continues to prepare for the potential approval and launch of
INVELTYSTM, which, if approved, is expected to be the first
twice-daily ocular corticosteroid indicated for the treatment of
post-operative ocular inflammation and pain. The
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 and can involve tear film instability, inflammation, discomfort, visual disturbance and ocular surface damage. KPI-121 0.25% utilizes Kala's mucus-penetrating particle (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 has completed one Phase 2 and two Phase 3 clinical trials of KPI-121 0.25%. 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 the 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 which could benefit from temporary relief of dry eye signs and symptoms.
KPI-121 0.25% achieved statistical significance for the primary sign endpoint of conjunctival hyperemia at Day 15 in the ITT population in both Phase 3 trials. KPI-121 0.25% also achieved statistical significance for the primary symptom endpoint of ocular discomfort severity at Day 15 in the ITT population in STRIDE 1 with a trend towards a treatment effect in STRIDE 2. Statistical significance was achieved for the second primary symptom endpoint of ocular discomfort severity at Day 15 in patients with a more severe baseline discomfort in STRIDE 1 with a strong trend towards a treatment effect observed for the same endpoint in STRIDE 2. Positive treatment effects were also observed for the symptom endpoint of ocular discomfort severity in the ITT population at Day 8 in both trials, which was a key pre-specified secondary endpoint.
KPI-121 0.25% was well-tolerated in both Phase 3 trials with elevation in intra-ocular pressure, a known side effect with topical corticosteroids, similar to placebo.
Additionally, a positive treatment effect was observed for the primary symptom endpoint of ocular discomfort at day 15 (p<0.0001) when pooling the data from STRIDE 1 and STRIDE 2.
Furthermore, the effect on ocular discomfort on each of the days between days 8 and 14 in STRIDE 1 and STRIDE 2 using the analysis that was pre-specified for day 15. P-values of less than 0.002 were observed for all days during that time period in STRIDE 1, and p-values less than 0.05 were observed on 6 of the 7 days during that time period in STRIDE 2.
INVELTYS™ (KPI-121 1%) is a twice-a-day corticosteroid for the treatment
of inflammation and pain following ocular surgery. INVELTYS utilizes
Kala's proprietary mucus-penetrating particle (MPP) technology to
enhance penetration into target tissues of the eye. In preclinical
studies, MPP increased delivery of a corticosteroid into ocular tissues
more than three-fold by facilitating penetration through the tear film
mucus. Two Phase 3 clinical trials have been successfully completed for
INVELTYS and statistical significance was achieved for both primary
efficacy endpoints in both trials. In each of these trials, INVELTYS was
well tolerated with no treatment-related serious adverse events
observed. Kala believes INVELTYS has a favorable treatment profile
compared to the standard of care for the treatment of inflammation and
pain following ocular surgery, due to its twice-a-day dosing regimen and
rapid onset of relief. The NDA for INVELTYS was accepted for review by
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. Kala’s product candidates are INVELTYS™ (KPI-121 1%)
for the treatment of inflammation and pain following ocular surgery, for
which an NDA has been accepted for review by the
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 Company's product candidates, including INVELTYS (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 Company's strategy, future operations, future financial position,
future revenue, projected costs, prospects, plans and objectives of
management, are forward-looking statements. The words "anticipate,"
"believe," "estimate," "expect," "intend," "may," "plan," "predict,"
"project," "target," "potential," "will," "would," "could," "should,"
"continue" and similar expressions are intended to identify
forward-looking statements, although not all forward-looking statements
contain these identifying words. The Company may not actually achieve
the plans, intentions or expectations disclosed in its forward-looking
statements, 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 the
Company’s Phase 3 clinical trials of KPI-121 0.25% will warrant
submission and filing of an NDA on the timeline expected, or at all;
whether any additional clinical trials will be initiated or required for
KPI-121 0.25% prior to submission or filing of an NDA, or at all, and
whether any such NDA will be approved; the Company’s ability to initiate
and complete clinical trials on the timeline expected, or at all;
whether the results of clinical trials will be positive and/or replicate
the results from earlier clinical development and/or preclinical
studies; that post-hoc analyses are normally given less weight by
regulatory authorities than pre-specified analyses; whether the
Company’s NDA for INVELTYS will be approved by its PDUFA date, or at
all; uncertainties inherent in the availability and timing of data from
ongoing clinical trials; uncertainties related to the Company’s ability
to obtain regulatory approvals to conduct trials or to market products;
the Company’s ability to build a sales force and prepare for commercial
launch on the timeline expected, or at all; whether the Company's cash
resources will be sufficient to fund the Company's foreseeable and
unforeseeable operating expenses and capital expenditure requirements
for the Company's expected timeline; other matters that could affect the
availability or commercial potential of the Company's product
candidates; and other important factors, any of which could cause the
Company's actual results to differ from those contained in the
forward-looking statements, discussed in the "Risk Factors" section of
the Company's most recently filed Quarterly Report on Form 10-Q and
other filings the Company makes with the
For Kala Pharmaceuticals, Inc.
Stephen Rutman, 212-362-1200