UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
PURSUANT TO RULE 13a-16 OR 15d-16
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report: July 17, 2023
(Commission File No. 001-39308)
CALLIDITAS THERAPEUTICS AB
(Translation of registrant’s name into
English)
Kungsbron 1, D5
SE-111 22
Stockholm, Sweden
(Address of registrant’s principal executive office)
Indicate by check mark whether the registrant files or will file annual
reports under cover of Form 20-F or Form 40-F.
Form 20-F x
Form 40-F ¨
INFORMATION CONTAINED IN THIS REPORT ON FORM
6-K
Enclosed hereto is a copy of an announcement published by Calliditas
Therapeutics AB on July 13, 2023.
The information contained in this Form 6-K, including Exhibit 99.1,
is hereby incorporated by reference into the registrant’s Registration Statements on Form F-3 (File No. 333-265881) and Form S-8
(File Nos. 333-240126 and 333-272594).
EXHIBIT INDEX
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
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CALLIDITAS THERAPEUTICS AB |
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Date: July 17, 2023 |
By: |
/s/ Fredrik Johansson |
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Fredrik Johansson |
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Chief Financial Officer |
Exhibit 99.1
Stockholm,
Sweden |
July
13, 2023 |
Calliditas
announces supportive interim data from Phase 2 head and neck cancer trial with lead NOX inhibitor candidate, setanaxib
Calliditas
Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced interim data from the proof-of-concept
Phase 2 trial in patients with squamous cell carcinoma of the head and neck (SCCHN) with its lead NOX 1 and 4 inhibitor product candidate,
setanaxib. The analysis reflects encouraging early clinical progression-free survival (PFS) results and is supportive of the presumed
anti fibrotic mode of action of setanaxib.
The
basis for the analysis consisted of a data set of 20 patients with recurrent or metastatic SCCHN, out of which 16 patients had evaluable
tumor size and PFS related results. Twelve (12) patients had tumor biopsies before and after treatment that were evaluable for the biomarker
analysis, which included transcriptomic analysis and also evaluated pathology markers such as SMA, Foxp3 regulatory T cells and PDL-1
CPS. Due to the small sample size and heterogeneity of the patient population, any inferences from the interim analysis should be treated
with caution.
The
transcriptomic analysis showed that the two top pathways impacted by the treatment were fibrosis-related signaling pathways (the
Idiopathic Pulmonary Fibrosis Signaling Pathway and Hepatic Fibrosis/Hepatic Stellate Cell Activation Pathway), providing support for
the presumed mode of action relating to modulation of activated (myofibroblastic) fibroblasts, as well as the ongoing clinical programs.
Pathology
analysis showed preliminary evidence of an increase in immunological activity within tumors of patients treated with setanaxib, with
favorable changes in Foxp3and PDL-1 CPS. As SMA levels at baseline were not balanced between the groups, and tumor biopsy samples were
generally small, it was not possible to draw any conclusions regarding setanaxib’s impact on SMA reduction.
In
terms of PFS, 7 out of the 16 evaluable patients were progression-free with either stable disease or partial response, out of which 6
were in the setanaxib arm and 1 was in the placebo arm. 6 of the 7 patients were still on the study drug at the time of the data read
out with the longest period on drug being reported as 21 weeks, related to a patient in the setanaxib arm.
“Based
on the encouraging clinical and transcriptomic results, data clearly support the continuation of the trial, which will read out on tumor
size and progression free survival in the full trial population next year. Also, it is interesting that the transcriptomic results clearly
pointed to beneficial impact on 2 fibrosis-related signaling pathways, supporting the presumed mode of action as well as our pipeline
programs. We are excited about the potential of setanaxib in disease areas where today treatment options are limited” said CEO
Renée Aguiar-Lucander.
“We
are pleased with these encouraging interim data in a patient population where additional effective treatments are needed, and look forward
to completing the study in collaboration with our excellent sites and investigators” said CMO Richard Philipson.
The
trial is a randomized, placebo-controlled, double-blind, proof-of-concept Phase 2 study investigating the effect of setanaxib 800 mg
twice daily in conjunction with pembrolizumab 200mg IV, administered every 3 weeks (an accepted standard treatment regimen for
SCCHN), in at least 50 patients with moderate or high CAF-density tumors. A tumor biopsy is taken prior to randomization and then
again after at least 9 weeks of treatment. Treatment will continue until unacceptable toxicity or tumor progression, as is typical
for oncology trials. The study is expected to read out final data in 2024.
For
further information, please contact:
Åsa
Hillsten, Head of IR, Calliditas Therapeutics
Tel.:
+46 764 03 35 43, Email: ir@calliditas.com
About
Calliditas
Calliditas
Therapeutics is a commercial stage biopharma company based in Stockholm, Sweden focused on identifying, developing and commercializing
novel treatments in orphan indications, with an initial focus on renal and hepatic diseases with significant unmet medical needs. Calliditas’
lead product, developed under the name Nefecon, has been granted accelerated approval by the FDA under the trade name TARPEYO® and
conditional marketing authorization by the European Commission under the trade name Kinpeygo®. Kinpeygo is being commercialized in
the European Union Member States by Calliditas’ partner, STADA Arzneimittel AG. Additionally, Calliditas is conducting a Phase
2b/3 clinical trial in primary biliary cholangitis and a Phase 2 proof-of-concept trial in head and neck cancer with its NOX inhibitor
product candidate, setanaxib. Calliditas’ common shares are listed on Nasdaq Stockholm (ticker: CALTX) and its American Depositary
Shares are listed on the Nasdaq Global Select Market (ticker: CALT).
Forward-Looking
Statements
This
press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including, without limitation, statements regarding Calliditas’ strategy, commercialization efforts, business plans, regulatory
submissions, clinical development plans, revenue and product sales projections or forecasts and focus, and the prospects for setanaxib
as a treatment for SCCHN. The words “may,” “will,” “could,” “would,” “should,”
“expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,”
“predict,” “project,” “potential,” “continue,” “target,” and similar expressions
are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any
forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to
a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed
or implied by any forward-looking statements contained in this press release, including, without limitation, any related to Calliditas’
business, operations, continued and additional regulatory approvals for TARPEYO and Kinpeygo, market acceptance of TARPEYO and Kinpeygo,
clinical trials, supply chain, strategy, goals and anticipated timelines, competition from other biopharmaceutical companies, revenue
and product sales projections or forecasts and other risks identified in the section entitled “Risk Factors” in Calliditas’
reports filed with the Securities and Exchange Commission. Calliditas cautions you not to place undue reliance on any forward-looking
statements, which speak only as of the date they are made. Calliditas disclaims any obligation to publicly update or revise any such
statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based,
or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking
statements contained in this press release represent Calliditas’ views only as of the date hereof and should not be relied upon
as representing its views as of any subsequent date.
Calliditas Therapeutics AB (PK) (USOTC:CLTEF)
過去 株価チャート
から 6 2024 まで 7 2024
Calliditas Therapeutics AB (PK) (USOTC:CLTEF)
過去 株価チャート
から 7 2023 まで 7 2024