Kadmon Initiates Phase 2 Placebo-Controlled Clinical Trial of Tesevatinib in Autosomal Dominant Polycystic Kidney Disease
November 13 2017 - 9:00AM
Business Wire
Kadmon Holdings, Inc. (NYSE:KDMN) today announced that the first
patient has been dosed in a Phase 2 clinical trial of tesevatinib
in autosomal dominant polycystic kidney disease (ADPKD), an
inherited disorder that frequently leads to end-stage renal
disease. Tesevatinib is the company’s tyrosine kinase
inhibitor.
The randomized, double-blind, placebo-controlled trial builds on
findings from Kadmon’s open-label, dose-finding Phase 2a study of
tesevatinib in ADPKD, which demonstrated that the 50 mg once daily
(QD) dose had an encouraging safety profile and was well tolerated
in this population.
The new study is enrolling up to 100 patients, randomized 1:1 to
receive tesevatinib 50 mg QD or placebo. The primary endpoint is
the change from baseline in height-adjusted total kidney volume at
12 months.
In addition to the ADPKD trial, in September 2017, the first
patient was dosed in Kadmon’s Phase 1 dose-finding clinical trial
of tesevatinib in patients with autosomal recessive polycystic
kidney disease (ARPKD), a rarer, more severe form of the disease
affecting newborns and children. There are no FDA-approved
therapies for ARPKD and there are no other candidates in clinical
trials for ARPKD in the United States.
“Tesevatinib has been shown to inhibit molecular pathways
central to the progression of PKD—mediated by its inhibition of the
epidermal growth factor receptor (EGFR) and Src family kinases—and
also accumulates in the kidneys, making it a promising therapeutic
candidate for this disease,” said Harlan W. Waksal, M.D., President
and CEO at Kadmon. “We are encouraged by the safety and
tolerability findings from our open-label study, and the initiation
of these trials signifies an important step in our effort to
address this unmet medical need.”
About Kadmon Holdings, Inc.
Kadmon Holdings, Inc. is a fully integrated biopharmaceutical
company developing innovative product candidates for significant
unmet medical needs. Our product pipeline is focused on autoimmune
and fibrotic diseases.
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statements is set forth in the Company's filings with the U.S.
Securities and Exchange Commission (SEC), including the Company's
Quarterly Report on Form 10-Q filed pursuant to Section 13 of the
Securities Exchange Act of 1934, as amended, with the SEC on
November 9, 2017. Investors and security holders are urged to read
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Kadmon Holdings, Inc.Ellen Tremaine, 646-490-2989Investor
Relationsellen.tremaine@kadmon.comorMaeve Conneighton,
212-600-1902maeve@argotpartners.com
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