• Development of C21 in IPF on track; final Phase 2a AIR data in first half of 2024 and Phase 2b ASPIRE initiation in first half of 2024
• AlmeeTM pivotal study COMPANION completion on-track; topline results expected to be announced this month
• Transition to late-stage development of C21 in IPF drives increased focus in pipeline; preclinical IMiD program to be discontinued
• Review ongoing for follow-on indications and molecules to complement development of C21 in IPF

Stockholm, January 2, 2024 – Vicore Pharma Holding AB (publ), unlocking the potential of a new class of drug candidates, angiotensin II type 2 receptor agonists (ATRAGs), today announced pipeline updates as the company continues to focus on development of C21 for idiopathic pulmonary fibrosis (IPF).

The updates announced today include confirmation that development of the lead program, C21 for IPF is on track, with final Phase 2a AIR[1] data in the first half of next year. In addition, start-up activities for the global, double-blind, placebo-controlled, 52-week, Phase 2b ASPIRE study of C21 for IPF are progressing with initiation expected in the first half of 2024. Development of the Almee digital therapy advances as well, with topline results of the COMPANION[2] pivotal study for anxiety associated with pulmonary fibrosis expected to be reported in January 2024.

In its early-stage pipeline, as a result of an on-going portfolio review process that aims to focus investments, Vicore will discontinue development of the preclinical IMiD program, inhaled thalidomide for IPF cough. The review is also expected to select the best possible follow-on indications and ATRAG molecules for further development in view of the unique characteristics of this upstream mechanism of action that drives tissue repair.

“With the strong clinical signal for C21 in IPF demonstrated in its May 2023 Phase 2a interim read out, Vicore is entering a stage of focus on driving this drug candidate through successful development,” said Ahmed Mousa, Chief Executive Officer of Vicore, “with this enhanced prioritization we will discontinue development of the preclinical IMiD program for IPF cough in favor of advancing the potentially transformative therapy C21 for IPF patients.”

“We are extremely committed to successful development of C21 for IPF,” said Bertil Lindmark, MD, PhD, newly appointed Chief Medical Officer of Vicore, “and ensuring allocation of resources to win in this space. We look forward to an impactful disclosure of final Phase 2a AIR data as well as initiating the global Phase 2b ASPIRE study in the first half of 2024.”

“Activation of the angiotensin II type 2 receptor is a potent protective mechanism with strong potential beyond IPF,” said Johan Raud, MD, PhD, Chief Scientific Officer of Vicore, “we are reviewing a number of indications where we believe this pathway can have a disease-modifying effect and pair well with the specific properties of our ATRAG molecules. We look forward to sharing more on our follow-on pipeline to complement development of C21 in IPF in due course.”

For further information, please contact:
Ahmed Mousa, CEO, tel: +1 607 437-0235, ahmed.mousa@vicorepharma.com  
Hans Jeppsson, CFO, tel: +46 70 553 14 65, hans.jeppsson@vicorepharma.com

This information was submitted for publication on January 2 at 08:00 CEST.

About Vicore Pharma Holding AB (publ)
Vicore is an innovative clinical-stage pharmaceutical company unlocking the potential of a new class of drugs with disease-modifying potential. The company is establishing a portfolio in respiratory diseases, including idiopathic pulmonary fibrosis (IPF). C21 is a first-in-class orally available small molecule angiotensin II type 2 receptor agonist (ATRAG) currently in phase 2a development for IPF. Almee™ (an investigational medical device in clinical development) is a digital therapeutic based on cognitive behavioral therapy created to address the psychological impact of living with pulmonary fibrosis. Using its unique expertise in ATRAG chemistry and biology, Vicore is further fueling its pipeline with several new therapies across additional potential indications. The company’s shares (VICO) are listed on Nasdaq Stockholm’s main market. For more information, see www.vicorepharma.com.

[1] NCT04533022
[2] NCT05330312