– Data Expected for Phase 2 Clinical Trial of KVD001 in Diabetic
Macular Edema Patients in the Second Half of 2019 –
– Second Oral Hereditary Angioedema Candidate Begins Phase 1 Clinical
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 5, 2018--
KalVista Pharmaceuticals, Inc. (NASDAQ:KALV), a clinical stage
pharmaceutical company focused on the discovery, development, and
commercialization of small molecule protease inhibitors, today announced
the initiation of two clinical trials: a Phase 2 proof-of-concept
clinical trial evaluating the safety, tolerability, and efficacy of
KVD001 as a treatment for diabetic macular edema (DME), as well as a
Phase 1 trial for KVD 900, the second candidate in the oral hereditary
angioedema (HAE) portfolio. Both trials commenced in December 2017, in
line with KalVista’s previously stated 2017 objectives.
“After working diligently with Merck since the announcement of our
collaboration in October, we are delighted to have begun a Phase 2
clinical trial of KVD001 in diabetic macular edema patients,” said
Andrew Crockett, Chief Executive Officer of KalVista. “We are
particularly hopeful that plasma kallikrein inhibition may offer
benefits in patients for whom anti-VEGF therapy doesn’t achieve a
sufficient response. In addition, 2018 will be an exciting year for our
hereditary angioedema portfolio, with our second oral plasma kallikrein
inhibitor candidate in a Phase 1 clinical trial and an anticipated
regulatory filing for a third candidate before year-end.”
KVD001 is a small molecule plasma kallikrein inhibitor administered by
intravitreal injection for the potential treatment of DME. The Phase 2
trial will consist of approximately 123 patients in the United States
who have discontinued treatment with anti-VEGF therapy, and who still
have significant edema and reduced visual acuity. This sham-controlled,
double-masked clinical trial will evaluate two dose levels of KVD001.
Four intravitreal injections, or sham, will be administered over three
months with a three month follow up period. Efficacy endpoints include
best corrected visual acuity (BCVA), central subfield thickness (CST),
and the diabetic retinopathy severity scale (DRSS). The safety and
tolerability of monthly dosing of KVD001 will also be assessed. Top-line
results are expected in the second half of 2019.
KVD900 is the second clinical candidate from a portfolio of oral plasma
kallikrein inhibitors for potential treatment of HAE. KalVista’s
strategy is to develop and evaluate multiple oral molecules in pursuit
of a best-in-class therapy for HAE patients. This portfolio approach may
also lead to development of multiple molecules to address unmet need in
both prophylactic and on-demand market segments. The Phase 1 trial of
KVD900 is actively screening healthy volunteers to evaluate the safety,
tolerability and exposure of the drug candidate, and a plasma-based
assay will be used to assess the pharmacodynamic effect of KVD900.
KalVista expects to provide an update on the status and progress of the
HAE portfolio, including KVD900, in mid-2018, with a goal to advance at
least one additional candidate to the clinic before the end of 2018.
About Diabetic Macular Edema (DME)
Diabetic macular edema (DME) is a sight-threatening disease caused by
disruption of the blood/retinal barrier leading to the accumulation of
fluid in the macula and vision loss. DME affects an estimated 16% of
diabetic patients within their lifetime, according to a 2012 study
published in Diabetes Care. Approximately 900,000 patients in the United
States alone have active DME and are at serious risk of vision loss,
according to a 2013 study.
About Hereditary Angioedema (HAE)
Hereditary angioedema (HAE) is a rare and potentially life-threatening
genetic condition that occurs in approximately 1 in 50,000 people. HAE
patients are susceptible to sudden and prolonged attacks of edema, which
often occur in the hands, feet, face, gastrointestinal tract, and
airway. Attacks can result in severe swelling and pain, airway blockage,
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on
the discovery, development, and commercialization of small molecule
protease inhibitors for diseases with significant unmet need. The
initial focus is on inhibitors of plasma kallikrein, which is an
important component of the body’s inflammatory response and which, in
excess, can lead to increased vascular permeability, edema, and
inflammation. KalVista has developed a proprietary portfolio of novel,
small molecule plasma kallikrein inhibitors initially targeting
hereditary angioedema (HAE) and diabetic macular edema (DME). The
Company has created a structurally diverse portfolio of oral plasma
kallikrein inhibitors from which it plans to select multiple drug
candidates to advance into clinical trials for HAE. KalVista’s most
advanced program, an intravitreally administered plasma kallikrein
inhibitor known as KVD001, has successfully completed its first-in-human
study in patients with DME and began a Phase 2 clinical trial in 2017.
For more information, please visit www.kalvista.com.
This press release contains "forward-looking" statements within the
meaning of the safe harbor provisions of the U.S. Private Securities
Litigation Reform Act of 1995. Forward-looking statements can be
identified by words such as: "anticipate," "intend," "plan," "goal,"
"seek," "believe," "project," "estimate," "expect," "strategy,"
"future," "likely," "may," "should," "will" and similar references to
future periods. These statements are subject to numerous risks and
uncertainties that could cause actual results to differ materially from
what we expect. Examples of forward-looking statements include, among
others, available funding and future clinical trial timing and results.
Further information on potential risk factors that could affect our
business and its financial results are detailed in the annual report on
Form 10-K filed on July 27, 2017, our most recent Quarterly Report on
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publicly update any forward-looking statement, whether written or oral,
that may be made from time to time, whether as a result of new
information, future developments or otherwise.
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Source: KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc.
Leah Monteiro, 857-999-0808
Corporate Communications & Investor Relations