Vicore’s AIR study interim analysis suggests that C21 improves lung function in IPF patients

2022-02-10 | Regulatory

· FVC increased by an average +251 ml over baseline at 24 weeks
· Between 24 and 36 weeks, FVC was either stable or continued to increase
· C21 was safe and well tolerated
· Planning of a phase 2b study is being initiated
· A webcast presentation will be held at 14:00 CET (8 AM EST) today with more study details

Gothenburg, February 10, 2022 – Vicore Pharma Holding AB (publ) (“Vicore”), a clinical-stage pharmaceutical company developing medicines targeting the angiotensin II type 2 receptor (AT2R), today announces data from an interim analysis suggesting that C21 stabilizes disease and increases lung function in idiopathic pulmonary fibrosis (IPF) patients as quantified by standard FVC (Forced Vital Capacity) measurement.

An interim analysis of the phase 2 proof-of-concept study in IPF (the AIR1study) showed an initial stabilization of disease and then an increase in FVC up to the end of the study at 36 weeks. At the time of the interim analysis, there were 21 evaluable patients of which 13, 9 and 7 patients reached 12, 24 and 36 weeks of treatment, respectively. After 24 weeks, the increase in mean FVC was +251 ml, a considerable difference of 371 ml compared to the expected decline of 120 ml in 24 weeks in an untreated population. Five of the seven patients who completed both 24 and 36 weeks of C21 treatment showed continued improvement in FVC and two remained stable. Analysis of FVC slope values at 28, 32 and 36 weeks are statistically significant (p=0.016 at 36 weeks) compared to the expected mean for untreated patients. The study drug was well tolerated with no related serious adverse events, acute exacerbations, or gastrointestinal signals.

“This is very encouraging data”, says Professor Toby Maher, clinical expert to Vicore “to see stabilization in patients over 36 weeks is certainly not something we would expect to see by chance in a clinical trial and definitely warrants further assessment of C21 in IPF”.

The AIR study is an open label single arm study in treatment naïve IPF patients in which 100 mg of C21 was administered twice daily for 24 weeks with an optional 12-week extension. The study is being conducted in the UK, India, Ukraine, and Russia. A correct diagnosis was secured by central reading of high-resolution computer tomography (HRCT). To assess lung volume, the gold standard for FVC measurements, the ERT system, was used at all sites.

“Based on the mechanism of action of C21, which has both vascular and antifibrotic characteristics, we were optimistic, but this exceeds our expectations” says Professor Joanna Porter, coordinating investigator in the AIR study.

With these results, the company initiates the planning of AIR 2, a double-blind controlled phase 2 dose-finding study to confirm these results and accelerate the development of C21 in parallel to completing the AIR trial.

“Now that the interim analysis has shown both safety and a positive effect on lung function in this trial, we want to move as quickly as possible to the next stage to be able to bring this treatment to patients” says Rohit Batta, Chief Medical Officer of Vicore.

Webcast presentation  
Vicore will host a webcast to present more details from the interim analysis at 14.00 CET (8:00 am EST) today that can be accessed via the link: https://financialhearings.com/event/44068

The presentation will be available before the webcast at:
https://vicorepharma.com/investors/events-presentations/

C21 – a first-in-class AT2R agonist            
C21 is a first-in-class, orally available, low molecular weight, angiotensin II type 2 receptor (AT2R) agonist that activates the “protective arm” of the renin-angiotensin system (RAS) leading to resolution and regeneration following tissue damage. The compound is currently in a phase 2 proof-of-concept trial in IPF and in a pivotal phase 3 trial in COVID-19.

For further information, please contact:
Carl-Johan Dalsgaard, CEO
Phone: +46 70 975 98 63
E-mail: carl-johan.dalsgaard@vicorepharma.com

This information is such that Vicore Pharma Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above on February 10, 2022 at 06:55 CEST.

Vicorepharma

On vicorepharma.com, we use so-called cookies to analyze how our website is used in order to optimize and improve it. You choose yourself whether you want to consent to our use of cookies.

Vicorepharma is responsible for placing cookies on the website and for the processing of your personal data collected by them. For more information about our processing of your personal data, see our privacy policy

Cookie policy

Your consent applies to the following domain: vicorepharma.com
The cookie policy was last updated: 2023-01-24

Privacy Policy

Show the cookies used on our website

Necessary cookies is needed in order for the website's basic functions to work correctly and for us to be able to save your choice of cookies.

  • cookies_set

    Purpose: Saves the visitor’s choice of cookies.
    Issued by: mk cookie master
    Lifespan: 1 year

    Domain: vicorepharma.com

  • selected_cookies

    Purpose: Saves the visitor’s choice of cookies.
    Issued by: mk cookie master
    Lifespan: 1 year

    Domain: vicorepharma.com

Marketing cookies is used to track visitors on the website. The intention is to show ads that are relevant and engaging to the individual user and thus be more valuable to publishers and third-party advertisers.

  • AMP_TOKEN

    Purpose: Contains a token that can be used to retrieve a unique user ID.
    Issued by: AMP
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _fbp

    Purpose: Used to store and track visits across websites.
    Issued by: Facebook
    Lifespan: 3 months

    Domain: vicorepharma.com

  • _gac_

    Purpose: Used to store and track audience reach.
    Issued by: Google Ads
    Lifespan: 90 days

    Domain: vicorepharma.com

  • _lfa

    Purpose: Used to store and track audience reach.
    Issued by: Leadfeeder
    Lifespan: 2 years

    Domain: vicorepharma.com

  • _lfa_test_cookie_stored

    Purpose: Used to test if _lfa was stored.
    Issued by: Leadfeeder
    Lifespan: 1 day

    Domain: vicorepharma.com

Statistical cookies helps the website owners to understand how visitors interact with the website by collecting and report this information.

  • _clck

    Purpose: Used to store a unique user ID.
    Issued by: Microsoft Clarity
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _clsk

    Purpose: Used to store and combine pageviews by a user into a single session recording.
    Issued by: Microsoft Clarity
    Lifespan: 1 day

    Domain: vicorepharma.com

  • _ga

    Purpose: Used to understand how visitors’ navigate around the website.
    Issued by: Google Analytics
    Lifespan: 2 years

    Domain: vicorepharma.com

  • _gat

    Purpose: Used to throttle request rate. If Google Analytics is deployed via Google Tag Manager, this cookie will be named _dc_gtm_.
    Issued by: Google Analytics
    Lifespan: 1 minute

    Domain: vicorepharma.com

  • _gid

    Purpose: Used to understand how visitors’ navigate around the website.
    Issued by: Google Analytics
    Lifespan: 1 day

    Domain: vicorepharma.com

  • _hjAbsoluteSessionInProgress

    Purpose: Used to store unique visits.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjFirstSeen

    Purpose: Used to identify a new visitors’ first session.
    Issued by: Hotjar
    Lifespan: Session

    Domain: vicorepharma.com

  • _hjid

    Purpose: Used to store a unique user ID.
    Issued by: Hotjar
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _hjIncludedInPageviewSample

    Purpose: Used to check if the visitor is included in the data sample defined by the site’s daily pageview limit.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjIncludedInSessionSample

    Purpose: Used to check if the visitor is included in the data sample defined by the site’s daily session limit.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjSessionUser{site_id}

    Purpose: Used to store a unique user ID.
    Issued by: Hotjar
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _hjSession{site_id}

    Purpose: A cookie that holds the current session data.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjTLDTest

    Purpose: Used to check if cookies can be loaded on the site and is removed shortly afterward.
    Issued by: Hotjar
    Lifespan: Session

    Domain: vicorepharma.com

What are cookies?

A cookie is a small text file that is placed on your device (computer/mobile/tablet that has access to the internet) by the website you visit – if you give your consent to this. The cookie can, for example, recognize you as a user when you visit our website and make it possible to remember important information that makes your visit more comfortable and provides an improved user experience. Cookies are so-called passive files that cannot spread dangerous software or viruses on your mobile device or computer.

 

There are two types of cookies, permanent cookies and session cookies. At vicorepharma.com we use both permanent cookies and session cookies. Permanent cookies are saved as a file on the computer for a certain time until the server that placed them, or you as a visitor choose to delete them. Session cookies are temporarily stored when you as a visitor are on the website and disappear when you close your browser.

 

Cookies can also be divided into first-party cookies and third-party cookies. First-party cookies are placed by the website you are visiting, while third-party cookies are placed by another website. At vicorepharma.com, we use both first-party cookies and third-party cookies.

 

How to avoid cookies

When you visit our website, you can refuse all or certain types of cookies. You can also withdraw or change your consent at any time by clicking here.

 

You can also block cookies by changing the settings in your browser. Then your browser will automatically refuse cookies or inform you when a website requests to store cookies.

 

After your visit, you can review and delete the permanent cookies that have been stored in your browser. In the list below, you will see the name of the cookies vicorepharma.com saves so that you can easily identify them.

 

Here you will find more information about how to manage cookies in your browser:

 

Cookies used by third parties

On vicorepharma.com there may be content that is embedded from YouTube. YouTube places cookies in your browser when you visit youtube.com or when you click on embedded content from YouTube on our website. vicorepharma cannot control these cookies or the personal data and information that may be collected. vicorepharma does not use the targeted marketing services offered by YouTube. As a user, you therefore need to check YouTube’s website for further information on how they manage cookies, what information they collect and how you can delete any third-party cookies.

Necessary cookies is needed in order for the website's basic functions to work correctly and for us to be able to save your choice of cookies.

  • cookies_set

    Purpose: Saves the visitor’s choice of cookies.
    Issued by: mk cookie master
    Lifespan: 1 year

    Domain: vicorepharma.com

  • selected_cookies

    Purpose: Saves the visitor’s choice of cookies.
    Issued by: mk cookie master
    Lifespan: 1 year

    Domain: vicorepharma.com

Marketing cookies is used to track visitors on the website. The intention is to show ads that are relevant and engaging to the individual user and thus be more valuable to publishers and third-party advertisers.

  • AMP_TOKEN

    Purpose: Contains a token that can be used to retrieve a unique user ID.
    Issued by: AMP
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _fbp

    Purpose: Used to store and track visits across websites.
    Issued by: Facebook
    Lifespan: 3 months

    Domain: vicorepharma.com

  • _gac_

    Purpose: Used to store and track audience reach.
    Issued by: Google Ads
    Lifespan: 90 days

    Domain: vicorepharma.com

  • _lfa

    Purpose: Used to store and track audience reach.
    Issued by: Leadfeeder
    Lifespan: 2 years

    Domain: vicorepharma.com

  • _lfa_test_cookie_stored

    Purpose: Used to test if _lfa was stored.
    Issued by: Leadfeeder
    Lifespan: 1 day

    Domain: vicorepharma.com

Statistical cookies helps the website owners to understand how visitors interact with the website by collecting and report this information.

  • _clck

    Purpose: Used to store a unique user ID.
    Issued by: Microsoft Clarity
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _clsk

    Purpose: Used to store and combine pageviews by a user into a single session recording.
    Issued by: Microsoft Clarity
    Lifespan: 1 day

    Domain: vicorepharma.com

  • _ga

    Purpose: Used to understand how visitors’ navigate around the website.
    Issued by: Google Analytics
    Lifespan: 2 years

    Domain: vicorepharma.com

  • _gat

    Purpose: Used to throttle request rate. If Google Analytics is deployed via Google Tag Manager, this cookie will be named _dc_gtm_.
    Issued by: Google Analytics
    Lifespan: 1 minute

    Domain: vicorepharma.com

  • _gid

    Purpose: Used to understand how visitors’ navigate around the website.
    Issued by: Google Analytics
    Lifespan: 1 day

    Domain: vicorepharma.com

  • _hjAbsoluteSessionInProgress

    Purpose: Used to store unique visits.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjFirstSeen

    Purpose: Used to identify a new visitors’ first session.
    Issued by: Hotjar
    Lifespan: Session

    Domain: vicorepharma.com

  • _hjid

    Purpose: Used to store a unique user ID.
    Issued by: Hotjar
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _hjIncludedInPageviewSample

    Purpose: Used to check if the visitor is included in the data sample defined by the site’s daily pageview limit.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjIncludedInSessionSample

    Purpose: Used to check if the visitor is included in the data sample defined by the site’s daily session limit.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjSessionUser{site_id}

    Purpose: Used to store a unique user ID.
    Issued by: Hotjar
    Lifespan: 1 year

    Domain: vicorepharma.com

  • _hjSession{site_id}

    Purpose: A cookie that holds the current session data.
    Issued by: Hotjar
    Lifespan: 30 minutes

    Domain: vicorepharma.com

  • _hjTLDTest

    Purpose: Used to check if cookies can be loaded on the site and is removed shortly afterward.
    Issued by: Hotjar
    Lifespan: Session

    Domain: vicorepharma.com

General

Vicore Pharma Holding AB (“Vicore”) shall only process personal data in accordance with applicable data protection law and high industry standards.

 

Personal data.

Vicore processes personal data provided to us;
(i) by you in the day-to-day communications, or

(ii) in connection with entering into or performing an agreement or business arrangement with you, or
(iii) by a third party allowed by law or your consent.

The personal data may consist of contact and identification details and other information relevant to the situation.

 

Purpose.

Vicore process personal data for the purpose of communicating with you and to perform, manage and comply with agreements between us as well as rights and obligations which are allowed by law or applicable regulation.

 

Legal grounds.

The legal grounds for processing personal data is either;
(i) your consent which shall be considered provided when you either voluntary submit the personal data or enter into an agreement with us, or
(ii) a legitimate interest allowed under law.

 

Security

Vicore shall use adequate technical and organisational security measures to protect the personal data from loss and to safeguard against access from unauthorised persons.

Transfers of personal data may only occur;
(i) to third parties who perform services on Vicore behalf and who may only process personal data in accordance with our instructions, and may not use personal data for their own purposes; and
(ii) outside the EU/EEA only in accordance with applicable data protection laws and subject to the EU Commission’s standard contractual clauses, and
(iii) as otherwise permitted by law or your consent.

Duration.

The duration we process personal data is limited to what is reasonable for the purpose of the processing, unless otherwise required or permitted by law.

 

Rights

Vicore is the controller of the personal data processing, meaning that we are responsible for that the personal data is processed correctly and in accordance with applicable data protection laws.

Unless prevented by applicable law, regulation or agreement data subjects have the right to;
(i) know what personal data we process about them,
(ii) request that we rectify or erase inaccurate or incomplete personal data
(iii) object to specific processing of personal data, and
(iv) receive the personal data provided by them and have the personal data transferred to another party responsible for data processing.

All communications with Vicore regarding how we process personal data or exercise of any of your rights can be sent by e-mail to info@vicorepharma.com or by post to the address above.

Reports and complaints can also be directed to Datainspektionen who is the supervisory authority for our processing of personal data.