In-Person & Virtual R&D Day: The Anti-Fibrotic Effects of Setanaxib and TARPEYO’s Mode of Action

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Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) (“Calliditas”) today announced that it will hold an in-person and virtual R&D day on Thursday, May 30, 2024 at 3:00 PM CET (9:00 AM ET). The event will be held at Inderes Event Studio, Västra Trädgårdsgatan 19, Stockholm.

The event will feature Gareth J. Thomas, PhD (University Hospital Southampton) and Jonathan Barratt, PhD, FRCP (University of Leicester) with the following program:

  • Supportive preclinical data and Phase 2 POC trial evaluating setanaxib, the Company's lead candidate from its NOX platform, in patients with squamous cell carcinoma of the head and neck (SCCHN)
  • The anti-fibrotic effects of Setanaxib in solid tumors and fibrotic diseases
  • Review of upcoming additional clinical data from the NOX platform
  • Support for mode of action of TARPEYO (Nefecon) in patients with primary IgA nephropathy (IgAN)

The event will include a discussion of positive clinical results and supportive pre-clinical and biomarker data recently announced for both programs, as well as an overview of the Company's pipeline and expected future data readouts.

A live question and answer session will follow the formal presentations.

Registration information

You are required to register in advance for this event by clicking here.

Q&A information

If you would like to ask a question during the live Q&A, please submit your request to questions@lifesciadvisors.com

KOL Biographies

Gareth J. Thomas is Professor of Experimental Pathology at the University of Southampton, UK. As a clinical pathologist and tumor biologist, Gareth Thomas’s research is focused how fibroblasts affect cancer progression, characterizing the phenotypes and functions of different fibroblast subpopulations and investigating how fibroblasts interact with immune cells to suppress anti-tumor immunity. The research has a strong translational component aiming to develop new therapies that target fibroblasts to overcome immunotherapy resistance.

Jonathan Barratt, PhD, FRCP leads the Renal Research Group within the Col-lege of Life Sciences, University of Leicester. His research is focused on a bench to bedside approach to improving our understanding of the pathogenesis of IgA nephropathy a common global cause of kidney failure. Jonathan is the IgA nephropathy Rare Disease Group lead for the UK National Registry of Rare Kidney Diseases (RaDaR) and a member of the steering committee for the In-ternational IgA Nephropathy Network. He is Chief Investigator for a number of international randomized controlled Phase 2 and 3 clinical trials in IgA nephropa-thy and was a member of the FDA and American Society of Nephrology Kidney Health Initiative: Identifying Surrogate Endpoints for Clinical Trials in IgA Nephropathy Work group.

For further information, please contact:

Åsa Hillsten, Head of IR & Sustainability, Calliditas

Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com

The information was sent for publication, through the agency of the contact persons set out above, on May 16, 2024 at 16:30 p.m. CET.

About Calliditas

Calliditas Therapeutics is a biopharma company headquartered in Stockholm, Sweden, focused on identifying, developing, and commercializing novel treatments in orphan indications with significant unmet medical needs. 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). Visit Calliditas.com for further information.

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. 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 and operations, the presumed mechanism of action of setanaxib, the safety and efficacy of setanaxib in SCCHN or other potential indications, anticipated timelines and other risks identified in the section entitled “Risk Factors” in Calliditas’ reports filed with the Securities and Exchange Commission. The results of early clinical trials may not predict those of future, later-stage clinical trials. The clinical data presented herein involves a limited number of patients, and these results may not be replicated in larger clinical trials. 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.

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