– 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 Trial –
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, and nausea.
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.
Forward-Looking Statements
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 Form
10-Q, and other reports as filed from time to time with
the Securities and Exchange Commission. We undertake no
obligation to 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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version on businesswire.com: http://www.businesswire.com/news/home/20180105005163/en/
KalVista Pharmaceuticals, Inc.Leah Monteiro,
857-999-0808Director, Corporate Communications & Investor
Relationsleah.monteiro@kalvista.com
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