Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical
company focused on the discovery, development and commercialization
of precision medicines for kidney diseases, today announced that
the first patient with IgA nephropathy (IgAN) has been enrolled in
the BEYOND study, a pivotal phase 3 clinical trial evaluating the
safety and efficacy of zigakibart (BION-1301), a potentially
disease-modifying anti-APRIL monoclonal antibody.
“Initiation of the phase 3 BEYOND study is an important step
towards our goal of providing an innovative treatment option for
patients with IgAN, a disease with high unmet need and limited
treatment options,” said Eric Dobmeier, president and chief
executive officer of Chinook Therapeutics. “The data from our
ongoing phase 1/2 trial of zigakibart supports our belief that
binding and neutralizing APRIL in patients with IgAN plays a key
role in depleting pathogenic galactose deficient-IgA1, reducing
proteinuria and preserving kidney function for IgAN patients.”
“I am pleased to see Chinook enroll the first patient in the
phase 3 BEYOND study of zigakibart in IgAN and look forward to the
study’s continued enrollment,” said Vlado Perkovic, MBBS, PhD,
FASN, FRACP, dean of medicine and health and Scientia professor at
University of New South Wales and co-chair of the BEYOND study
steering committee. “IgAN is the most common primary glomerular
disease worldwide with limited treatment options currently
available, causing many patients to progress to end-stage kidney
disease, requiring dialysis or kidney transplant. With the
potential to be disease-modifying based on the encouraging results
observed in the phase 1/2 study, I believe zigakibart could be an
important new therapeutic treatment option for patients with
IgAN.”
About the BEYOND StudyThe BEYOND study (see
www.clinicaltrials.gov, identifier NCT05852938) is a global,
randomized, multicenter, double-blind, placebo-controlled phase 3
clinical trial comparing the safety and efficacy of zigakibart
versus placebo in patients with IgAN at risk of progressive loss of
kidney function. Approximately 272 patients with biopsy-proven IgAN
and eGFR ≥ 30 mL/min/1.73m2 will be randomized to receive 600 mg of
zigakibart or a matched placebo subcutaneously every two weeks for
104 weeks. An additional exploratory cohort, not included in the
primary analysis, will be comprised of approximately 20 subjects
(10 subjects per arm) with biopsy-confirmed IgAN and eGFR of ≥ 20
to < 30 mL/min/1.73 m2.
The primary efficacy endpoint of the BEYOND study is to evaluate
the effect of zigakibart versus placebo on proteinuria as measured
by change in urine protein to creatinine ratio (UPCR) from baseline
to 40 weeks. Secondary and exploratory objectives include
evaluating change in eGFR from baseline to week 104; composite
clinical outcome of 30% or 40% reduction in eGFR, eGFR < 15
mL/min/1.73m2 or dialysis, kidney transplantation or all-cause
mortality; safety and tolerability; impact of zigakibart on disease
biomarkers and health-related quality of life, as well as analysis
of zigakibart pharmacokinetics and immunogenicity.
About Chinook Therapeutics, Inc.Chinook
Therapeutics, Inc. is a clinical-stage biopharmaceutical company
developing precision medicines for kidney diseases. Chinook’s
product candidates are being investigated in rare, severe chronic
kidney disorders with opportunities for well-defined clinical
pathways. Chinook’s lead program is atrasentan, a phase 3
endothelin receptor antagonist for the treatment of IgA nephropathy
and proteinuric glomerular diseases. Zigakibart (BION-1301), an
anti-APRIL monoclonal antibody, is being evaluated in a phase 3
trial for IgA nephropathy. CHK-336, an oral small molecule LDHA
inhibitor for the treatment of hyperoxalurias, is in phase 1
development. In addition, Chinook’s research and discovery efforts
are focused on building a pipeline of precision medicines for rare,
severe chronic kidney diseases with defined genetic and molecular
drivers. Chinook is leveraging insights from kidney single cell RNA
sequencing and large CKD patient cohorts that have been
comprehensively panomically phenotyped, with retained biosamples
and prospective clinical follow-up, to discover and develop
therapeutic candidates with mechanisms of action targeted against
key kidney disease pathways. To learn more, visit
www.chinooktx.com.
Forward-Looking Statements In addition to
historical information, this communication contains forward-looking
statements within the meaning of applicable securities law,
including statements regarding the advancement of its product
candidates and product pipeline, and the clinical development of
its product candidates, including expectations regarding the
results of clinical trials. In addition, when used in this
communication, the words “will,” “expects,” “could,” “would,”
“may,” “anticipates,” “intends,” “plans,” “believes,” “seeks,”
“targets,” “estimates,” “looks for,” “looks to,” “continues” and
similar expressions, as well as statements regarding our focus for
the future, are generally intended to identify forward-looking
statements. Each of the forward-looking statements we make in this
communication involves risks and uncertainties that could cause
actual results to differ materially from these forward-looking
statements. Factors that might cause or contribute to such
differences include, but are not limited to: expected revenues,
cost savings, synergies and other benefits from the proposed merger
might not be realized within the expected time frames or at all and
costs or difficulties relating to integration matters, including
but not limited to employee retention, might be greater than
expected; the requisite regulatory approvals and clearances for the
proposed transaction may be delayed or may not be obtained (or may
result in the imposition of conditions that could adversely affect
the combined company or the expected benefits of the proposed
merger); the requisite approval of Chinook stockholders may be
delayed or may not be obtained, the other closing conditions to the
proposed merger may be delayed or may not be obtained, or the
merger agreement may be terminated; business disruption may occur
following or in connection with the proposed merger; Novartis or
Chinook’s businesses may experience disruptions due to
transaction-related uncertainty or other factors making it more
difficult to maintain relationships with employees, other business
partners or governmental entities; the milestones for the proposed
contingent value rights may not be achieved; the possibility that
the proposed merger is more expensive to complete than anticipated,
including as a result of unexpected factors or events; and
diversion of management’s attention from ongoing business
operations and opportunities as a result of the proposed merger or
otherwise. Additional factors that may affect the future results of
Novartis and Chinook are set forth in their respective filings with
the U.S. Securities and Exchange Commission (the “SEC”), including
in the Definitive Proxy Statement of Chinook relating to the
proposed merger filed on July 10, 2023, as amended by the
definitive additional materials filed with the SEC on July 26,
2023, the most recently filed annual report of Novartis on Form
20-F, subsequently filed Current Reports on Form 6-K and other
filings with the SEC, which are available on the SEC’s website at
www.sec.gov, and Chinook’s most recently filed Annual Report on
Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current
Reports on Form 8-K and other filings with the SEC, which are
available on the SEC’s website at www.sec.gov. The risks described
in this communication and in Novartis and Chinook’s filings with
the SEC should be carefully reviewed. Undue reliance should not be
placed on these forward-looking statements, which speak only as of
the date they are made. Novartis and Chinook undertake no
obligation to publicly release any revisions to the forward-looking
statements or reflect events or circumstances after the date of
this communication, except as required by law.
No Offer or SolicitationThis communication does
not constitute an offer to sell or the solicitation of an offer to
buy any securities or a solicitation of any vote or approval with
respect to the proposed merger or otherwise. No offer of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as
amended.
Additional Information and Where to Find ItIn
connection with the proposed merger between Novartis and Chinook,
Chinook filed the Definitive Proxy Statement with the SEC on July
10, 2023, and filed definitive additional materials with the SEC on
July 26, 2023. The Definitive Proxy Statement and proxy card has
been delivered to the stockholders of Chinook in advance of the
special meeting relating to the proposed merger. CHINOOK’S
STOCKHOLDERS ARE URGED TO READ THE DEFINITIVE PROXY STATEMENT AND
DEFINITIVE ADDITIONAL MATERIALS IN THEIR ENTIRETY AND ANY OTHER
DOCUMENTS FILED BY EACH OF NOVARTIS AND CHINOOK WITH THE SEC IN
CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED BY REFERENCE
THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE
PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION.
Investors and security holders are able to obtain a free copy of
the Definitive Proxy Statement, definitive additional materials and
such other documents containing important information about
Novartis and Chinook through the website maintained by the SEC at
www.sec.gov. Novartis and Chinook make available free of charge at
the Novartis website and Chinook’s website, respectively (in the
“Investors” section), copies of materials they file with, or
furnish to, the SEC. The contents of the websites referenced above
are not deemed to be incorporated by reference into the Definitive
Proxy Statement.
Participants in the SolicitationThis document
does not constitute a solicitation of proxy, an offer to purchase
or a solicitation of an offer to sell any securities. Novartis,
Chinook and their respective directors, executive officers and
certain employees may be deemed to be participants in the
solicitation of proxies from the stockholders of Chinook in
connection with the proposed merger. Information regarding the
special interests of these directors and executive officers in the
proposed merger is included in the Definitive Proxy Statement
referred to above. Security holders may also obtain information
regarding the names, affiliations and interests of the Novartis
directors and executive officers in the Novartis Annual Report on
Form 20-F and Form 20-F/A for the fiscal year ended December 31,
2022, which were filed with the SEC on February 1, 2023, and May
15, 2023, respectively. Security holders may obtain information
regarding the names, affiliations and interests of Chinook’s
directors and executive officers in Chinook’s Annual Report on Form
10-K for the fiscal year ended December 31, 2022, which was filed
with the SEC on February 27, 2023, and its definitive proxy
statement for the 2023 annual meeting of stockholders, which was
filed with the SEC on April 28, 2023. To the extent the holdings of
Chinook’s securities by Chinook’s directors and executive officers
have changed since the amounts set forth in Chinook’s definitive
proxy statement for its 2023 annual meeting of stockholders, such
changes have been or will be reflected on Statements of Change in
Ownership on Form 4 filed with the SEC. Additional information
regarding the interests of such individuals in the proposed merger
is included in the Definitive Proxy Statement relating to the
proposed merger, which was filed with the SEC on July 10, 2023, as
amended by the definitive additional materials filed with the SEC
on July 26, 2023. These documents (when available) may be obtained
free of charge from the SEC’s website at www.sec.gov, the Novartis
website at https://www.novartis.com and Chinook’s website at
https://www.chinooktx.com. The contents of the websites referenced
above are not deemed to be incorporated by reference into the
Definitive Proxy Statement.
Investor Contact:
Noopur Liffick, MPH
Senior Vice President, Investor Relations & Corporate Communications
investors@chinooktx.com
Media Contact:
Kelly North
Senior Manager, Investor Relations & Corporate Communications
media@chinooktx.com
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