Vicore obtains significant new patent protection for C21 in the US

Stockholm, May 23, 2023 – Vicore Pharma Holding AB (STO:VICO) (“Vicore”) today announces issuance of a new US patent protecting an improved C21 formulation based on enteric coated compositions. The drug candidate C21 is currently in a phase 2a trial in idiopathic pulmonary fibrosis (IPF).

The patent provides strong protection in the US because the granted patent claims:

• relate to any form of enteric coating of C21; and
• are not limited to any specific disease

Carl-Johan Dalsgaard, CEO of Vicore comments “This is a very important milestone for Vicore. By prolonging protection in the US to at least 2041, it substantially increases the commercial potential of C21 in IPF beyond current assumptions based on orphan drug status and data protection.”

The United States Patent and Trademark Office (USPTO) today issued US Patent No. 11,654,115 entitled “New Delayed Release Composition for Peroral Administration.” The patent relates to a new invention that fundamentally improves C21 uptake through enteric coated tablets that dissolve only when reaching the small intestine. The patent protects any form of enteric coating of C21 and is expected to last at least until 2041. Corresponding patent applications have been filed in multiple jurisdictions in Europe and the rest of the world, including China and Japan. 

“We are very pleased that the USPTO has recognized the unique benefits of this technology” says Johan Raud, CSO of Vicore. “Importantly, the patent provides protection for C21 in all diseases.”

In an interim analysis of the ongoing phase 2a trial, C21 has shown unmatched effects by increasing lung capacity in patients with IPF, a devastating disease which untreated results in a steady decline in lung capacity and a typical life expectancy of three to five years after diagnosis. C21 acts by preventing the scarring process characteristic of IPF, thereby restoring alveolar integrity and improving lung function.

“In IPF alone, the potential value of this critical patent is material considering that the US IPF market represents $2.8 bn in annual sales, despite the limitations of current therapies”, says Carl-Johan Dalsgaard.