Vicore Pharma Holding AB (publ) announced that the UK MHRA (Medicines and Healthcare products Regulatory Agency) has awarded Vicore Innovation Passport designation for C21 in idiopathic pulmonary fibrosis (IPF), a life-threatening and seriously debilitating condition. C21 recognized by MHRA as an innovative and potentially important medicine for the treatment of IPF. Innovation Passport designation aims to accelerate time to market and facilitate patient access.

C21 meets the ILAP qualifying criteria as an innovative medicine with potential benefit to patients with IPF - a rare life-threatening disease for which there is a significant patient and public health need. Vicore has a strong history of collaboration with the scientific community, regulators, and patient representatives. The Innovation Passport designation provides a unique opportunity to further strengthen this multi-stakeholder collaboration.

A toolkit supports the advancement of a product through to regulatory approval and can accelerate time to market. About ILAP, Innovation Passport and Target Development Profile. ILAP (Innovative Licensing and Access Pathway) was established in January 2021 to support innovative approaches to the safe, timely and efficient development of medicines to improve patient access.

The Innovation Passport is granted by the ILAP Steering Group, consisting of representatives from MHRA (Medicines and healthcare products Regulatory Agency), NICE (National Institute for Health and Care Excellence), SMC (Scottish Medicines Consortium) and AWTTC (All Wales Therapeutics and Toxicology Centre). The ILAP provides companies with opportunities for enhanced regulatory and other stakeholder input and includes access to a co-created Target Development Profile (TDP). The TDP toolkit supports the advancement of an product through to regulatory approval and patient access by creating a roadmap and identifying key areas for engagement.

About C21 - first-in-class ATRAG (angiotensin II type 2 receptor agonist): C21 is an innovative, first-in-class, orally available, selective, small molecule ATRAG under development for the treatment of IPF (idiopathic pulmonary fibrosis). C21 has orphan drug designation in IPF both in Europe and the US. The novel and multimodal mechanism of action of C21 targets the underlying fibrosis in IPF by stimulating the protective arm of the renin-angiotensin system (RAS).

Consequently, there is an effect in terms of promoting alveolar repair and maintenance of alveolar integrity thereby reducing fibrosis formation, stabilising disease, and increasing lung capacity.