Vicore announces FDA acceptance for pivotal phase 3 trial of C21 in COVID-19

Gothenburg, June 11, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical company developing innovative medicines for fibrotic lung disorders such as idiopathic pulmonary fibrosis (IPF), today announces that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for the company's lead asset, the orally available angiotensin II type 2 receptor (AT2R) agonist C21, for the treatment of COVID-19. The active IND enables initiation of US sites in Vicore's pivotal phase 3 trial, ATTRACT-3.

ATTRACT-3 trial is a randomized, double-blind, placebo-controlled, multinational, phase 3 trial that will include 600 adult patients hospitalized with COVID-19 requiring oxygen support but not mechanical ventilation. The primary objective is to evaluate the effect of C21 on recovery from COVID-19. Vicore's Phase 2 trial (ATTRACT) in COVID-19 showed that C21 significantly reduced the extended need for supplemental oxygen therapy, indicating faster recovery on C21 compared to placebo.

In ATTRACT-3, patients will be randomized to receive 100 mg C21 or placebo twice daily on top of standard of care (SoC) for 14 days and patients will be followed for 60 days. Trial preparations are currently ongoing in countries in North America, South and Central America, Europe, Africa and Asia. Topline results from ATTRACT-3 are expected during the first quarter of 2022. 

"Morbidity and mortality in COVID-19 are still significant, particularly in moderate to severe disease, and our earlier trial indicates that C21 has the potential to improve respiratory outcomes and promote recovery in these patients," said Carl-Johan Dalsgaard, CEO of Vicore. "The FDA's acceptance of our first IND with C21 represents an important milestone in preparing our global phase 3 trial."

C21 in COVID-19 - improved respiratory outcomes
Results from the phase 2 ATTRACT study on 106 hospitalized patients with COVID-19, showed a significantly reduced risk for the need of supplemental oxygen (90% compared to placebo at day 14; P=0.003) and numerically fewer deaths and cases of patients requiring mechanical ventilation.

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). The compound has shown robust effects in human idiopathic pulmonary fibrosis (IPF) lung slices and a phase 2 proof-of-concept study in IPF is currently ongoing. Given that AT2R agonism has therapeutic potential in several additional indications with significant unmet medical needs, Vicore has intensified the efforts to develop proprietary follow-up molecules with differentiated profiles.

For further information, please contact:
Carl-Johan Dalsgaard, CEO
Phone: +46 70 975 98 63
E-mail: [email protected]

This information was submitted for publication on June 11, 2021 at 08.00 CET.

About Vicore Pharma Holding AB (publ)
Vicore is a rare disease pharmaceutical company focused on fibrotic lung disease and related indications. The company currently has four development programs, VP01, VP02, VP03 and VP04. VP01 aims to develop the substance C21 for the treatment of idiopathic pulmonary fibrosis (IPF) and COVID-19. VP02 is based on a new formulation and delivery route of thalodimide and focuses on the underlying disease and the severe cough associated with IPF. VP03 includes the development of new AT2R agonists. VP04 develops a clinically validated digital therapeutic for IPF patients.

The company's shares (VICO) are listed on Nasdaq Stockholm's main market. For more information, see www.vicorepharma.com

Vicore håller webbinarium om C21 för behandling av idiopatisk lungfibros (IPF)

Webbinariet hålls torsdagen den 30 september @16:00 CET (10:00 am EST) med läkarna och IPF-experterna, Prof. Toby Maher och Prof. Joanna Porter.

Göteborg, 22 september, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsbolag som utvecklar innovativa läkemedel mot svåra lungsjukdomar meddelar idag att bolaget kommer att hålla ett webbinarium om C21, Vicores ledande läkemedelsmolekyl, för behandling av idiopatisk lungfibros (IPF), torsdagen den 30 september kl. 16:00 CET (10:00 am EST).


Vicore to host Key Opinion Leader webinar on C21 for the treatment of idiopathic pulmonary fibrosis (IPF)

Webinar on Thursday, September 30 @ 16:00 CET (10AM ET) with the medical doctors and IPF experts Prof. Toby Maher and Prof. Joanna Porter.

Gothenburg, September 22, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical company developing innovative medicines for severe lung disorders such as idiopathic pulmonary fibrosis (IPF), today announced it will host a key opinion leader (KOL) webinar on C21, the company's lead asset for the treatment of idiopathic pulmonary fibrosis (IPF) on Thursday, September 30, 2021 at 16:00 CET (10 AM Eastern Time).


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Göteborg, 22 september, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsföretag som utvecklar innovativa behandlingar mot svåra lungsjukdomar, meddelar idag att US Patent and Trademark Office (USPTO) har beviljat patentet US11,123,329 som omfattar användningen av C21 för att behandla infektioner orsakade av Severe Acute Respiratory Syndrome (SARS) coronavirus (CoV), inklusive SARS-CoV-2.


Vicore behandlar första COVID-19 patienterna i den globala fas 3-studien ATTRACT-3

Göteborg, 17 september, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsbolag som utvecklar innovativa läkemedel mot svåra lungsjukdomar meddelar idag att de första patienterna i bolagets globala fas 3-studie med C21 i COVID-19 (ATTRACT-3) doserats.

  • Tidigare rapporterade positiva resultat från fas 2-studien ger starkt stöd för fortsatt utvärdering av Vicores AT2 receptor agonist C21 i COVID-19
  • Den pivotala fas 3-studien är nu godkänd i USA, Ukraina, Sydafrika, Brasilien, Tjeckien, Filippinerna och Indien med syftet att undersöka effektiviteten och säkerheten av C21 på sjukhusinlagda patienter med COVID-19

Göteborg, 17 september, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsbolag som utvecklar innovativa läkemedel mot svåra lungsjukdomar meddelar idag att de första patienterna i bolagets globala fas 3-studie med C21 i COVID-19 (ATTRACT-3) doserats.


Vicore starts dosing of first COVID-19 patients in the global phase 3 trial ATTRACT-3

Gothenburg, September 17, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical company developing innovative medicines for severe lung disorders today announces the dosing of the first patients in the company's global phase 3 trial of C21 in COVID-19 (ATTRACT-3).

  • Previously reported positive phase 2 trial results strongly support further evaluation of the Vicore AT2 receptor agonist C21 in COVID-19
  • The pivotal phase 3 trial is currently approved in the US, Ukraine, South Africa, Brazil, Czechia, Philippines and India to investigate the efficacy and safety of C21 in hospitalized patients with COVID-19

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Göteborg, 27 augusti, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), ett särläkemedelsbolag som utvecklar innovativa läkemedel för fibrotiska lungsjukdomar som idiopatisk lungfibros (IPF), meddelar idag att bolagets ledningsgrupp stärks med tre seniora rekryteringar när bolagets forsknings- och utvecklingsaktiviteter närmar sig viktiga kommersiella milstolpar.


Delårsrapport april - juni 2021

Göteborg, 26 augusti 2021 - Vicore Pharma Holding AB (publ) publicerar sin delårsrapport för andra kvartalet 2021.


Interim report April - June 2021

Gothenburg, August 26, 2021 - Vicore Pharma Holding AB (publ) publishes the interim report for the second quarter 2021.


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Göteborg, 15 juni, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), som ett särläkemedelsbolag som utvecklar innovativa läkemedel mot fibrotiska lungsjukdomar som idiopatisk lungfibros (IPF), meddelar idag om deltagande i två investerarkonferenser under juni månad 2021.


Vicore har erhållit godkännande från FDA för att starta en pivotal fas 3-studie med C21 i COVID-19

Göteborg, 11 juni, 2021 - Vicore Pharma Holding AB (publ) ("Vicore") ett särläkemedelsbolag som utvecklar innovativa läkemedel mot fibrotiska lungsjukdomar som idiopatisk lungfibros (IPF), meddelar idag att amerikanska U.S. Food and Drug Administration (FDA) har godkänt dess Investigational New Drug (IND)-ansökan för bolagets läkemedelskandidat och oralt tillgängliga angiotensin II type 2 receptor (AT2R) agonist, C21, för behandling av COVID-19. En aktiv IND gör det möjligt att påbörja bolagets pivotala fas 3-studie, ATTRACT-3, i USA.


Vicore announces FDA acceptance for pivotal phase 3 trial of C21 in COVID-19

Gothenburg, June 11, 2021 - Vicore Pharma Holding AB (publ) ("Vicore"), a rare disease pharmaceutical company developing innovative medicines for fibrotic lung disorders such as idiopathic pulmonary fibrosis (IPF), today announces that the U.S. Food and Drug Administration (FDA) has accepted the Investigational New Drug (IND) application for the company's lead asset, the orally available angiotensin II type 2 receptor (AT2R) agonist C21, for the treatment of COVID-19. The active IND enables initiation of US sites in Vicore's pivotal phase 3 trial, ATTRACT-3.


Kommuniké från årsstämma i Vicore Pharma Holding AB (publ)

Vid årsstämma i Vicore Pharma Holding AB (publ) den 11 maj 2021 fattades följande beslut.


Delårsrapport januari - mars 2021

Göteborg, 5 maj 2021 - Vicore Pharma Holding AB (publ) publicerar sin delårsrapport för första kvartalet 2021.


Interim report January - March 2021

Gothenburg, May 5, 2021 - Vicore Pharma Holding AB (publ) publishes the interim report for the first quarter 2021.


Vicore inleder samarbete med Alex Therapeutics för att utveckla en digital terapi för patienter med IPF

  • Webbinarium kommer hållas idag kl. 15:00 CET (9:00 am EST)
  • Jessica Shull, expert på digitala terapier har rekryterats till Vicore för att driva DTx-programmet

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