Phase 2 Trial of C21, Potential Oral Therapy for IPF, Opens

Phase 2 Trial of C21,  Potential Oral Therapy for IPF, Opens
4.7
(17)

A first patient has been enrolled in a proof-of-concept Phase 2 trial of C21 (VP01), Vicore Pharma’s investigational oral therapy for idiopathic pulmonary fibrosis (IPF) and other lung diseases.

“We are pleased to announce that we can now start our IPF trial despite the ongoing COVID-19 pandemic,” Anne Katrine Cohrt, senior director of clinical operations at Vicore Pharma, said in a press release.

The patient was recruited to the study (NCT04533022) at a site in India. Other sites are to open in the U.K., where the trial has been approved, and preparations are underway to expand the study to other countries. Contact and site information will become available here.

This open-label and single-arm trial aims to assess the safety, efficacy, and pharmacological properties of C21 in around 60 adults with IPF (ages 40 and older). Enrolled participants will receive the experimental therapy twice daily for six months.

After completing this initial treatment period, patients will have the option to continue treatment with C21 for an additional three months.

The study’s main goal is to assess the frequency and severity of side effects occurring over the first six months of treatment with C21.  Its effect on patients’ lung function and its pharmacokinetic properties — how C21 is distributed and processed in the body, and then eliminated — will also be evaluated.

C21 is a first-in-class activator of angiotensin II receptor type 2 (AT2R), a protein receptor that when active promotes blood vessel widening and prevents tissue scarring (fibrosis) by activating the “protective arm” of the renin-angiotensin system (RAS) signaling cascade.

Through this mechanism of action, C21 is expected to improve blood flow and reduce the formation of scar tissue in the lungs.

While C21 is mainly being investigated as a possible IPF treatment, its potential to treat people with systemic sclerosis or acute COVID-19 infection is also being explored.

Preclinical studies in animal models of pulmonary fibrosis and pulmonary hypertension are reported to have shown C21 as effective at lowering tissue fibrosis. More recently, the investigational therapy was also found to successfully block the activity of transforming growth factor-beta 1, a key regulator of fibrosis, in lung tissue samples taken from an IPF patient.

C21 has been named an orphan drug by regulatory authorities in the U.S. and Europe, supporting its testing and further development.

Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that made up the lining of blood vessels — found in the umbilical cord of newborns.
Total Posts: 110
Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.
×
Joana holds a BSc in Biology, a MSc in Evolutionary and Developmental Biology and a PhD in Biomedical Sciences from Universidade de Lisboa, Portugal. Her work has been focused on the impact of non-canonical Wnt signaling in the collective behavior of endothelial cells — cells that made up the lining of blood vessels — found in the umbilical cord of newborns.
Latest Posts
  • Phase 2 trial opens
  • chest lymph nodes
  • mortality, IPF
  • Diagnostic test for IPF

How useful was this post?

Click on a star to rate it!

Average rating 4.7 / 5. Vote count: 17

No votes so far! Be the first to rate this post.

As you found this post useful...

Follow us on social media!

We are sorry that this post was not useful for you!

Let us improve this post!

Tell us how we can improve this post?