The company received issuance of the new US patent to protect C21 that is based on enteric coated compositions and made the announcement today (May 23).
Vicore says the strong protection in the US and 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) has issued US Patent No. 11,654,115 entitled ‘New Delayed Release Composition for Peroral Administration’.
The patent specifically relates to an invention that fundamentally improves C21 uptake through enteric coated tablets that dissolve only when reaching the small intestine. In more detail, 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.
Data from the phase 2a trial, called Air, which had 51 IPF patients enrolled over 36-weeks, revealed that C21 has the potential to transform the treatment of the disease and restore lung function.
Increase in lung function
This news comes shortly after new 36-week data from its a trial named Air demonstrating disease stabilization and increase in lung function in 51 IPF patients was released. The disease is currently considered to be incurable and inevitably progressive.
The researchers found that C21 continues to demonstrate long-term efficacy, at 36 weeks the average measure of lung capacity or FVC (forced vital capacity) had increased to +350 mL over baseline, which is +530 mL over the expected trajectory of untreated patients.
Vicore plans to progress clinical development of C21 through initiation of a phase 2b trial called Andas and will conclude recruitment to the Air trial.
Professor Toby Maher, Keck School of Medicine at University of Southern California, said: “The magnitude of FVC stabilization seen with C21 in the Air trial is very different from what we normally see in clinical practice and certainly gives hope for patients. If data are replicated in the Andas trial, there will be a fundamental change in how IPF is treated with an opportunity to stop progression and restore lung function”.
The researchers reported that the time of analysis, 27 patients had completed 24 weeks of treatment with an average increase in FVC of +50mL and a three-visit average increase of +110, and 19 patients had completed 36 weeks of treatment with an average increase in FVC of +350 mL and a three-visit average increase of +220mL.
They said that out of the 19 patients that had completed 36 weeks of treatment, 17 presented an FVC value that was better than what would have been expected of an untreated population. The new dataset shows a stabilization of lung capacity already at week six and, in line with previous interim analysis, a subsequent increase of FVC from week 16 to 36.
Now, with twice the number of patients versus the interim analysis announced in November 2022, the previously reported early stabilization followed by an increase in lung function is confirmed, suggesting that C21 has the potential to transform the treatment of IPF.
Unique long-term stabilization
Carl-Johan Dalsgaard, CEO of Vicore, said: “The long-term stabilization and increase in FVC is unique for patients treated with C21 and consistent with the mechanism of action of an ATRAG. Restoring alveolar integrity is key in treating IPF and that is what C21 is doing”.
Recruitment to the Air trial will be concluded to fully focus on the next step of development, the phase 2b ANDAS trial. Vicore has engaged world leading experts and patient advocacy organizations in its advisory committee to aid in the design and successful conduct of the trial.
Rohit Batta, CMO of Vicore said: “We are thrilled to see that the previously reported long-term stabilization and increase in FVC holds through with now double the number of patients in the AIR trial. These results are truly encouraging regarding the future clinical development of C21 and our ambition to provide a treatment for IPF patients as soon as possible.”