EXCLUSIVE: ChemoCentryx Plans To Start Phase 3 Avacopan Trial In Chronic Skin Disorder In 2022

After a tight advisory committee vote back in May tilted just slightly in favor of approving ChemoCentryx Inc's CCXI avacopan, the FDA has cleared the drug for an autoimmune disorder that destroys the small blood vessels.

Related Link: Why Did ChemoCentryx Shares Soar 70% On Friday Premarket?

In an emailed comment from CCXI's president, Thomas J. Schall, said, "we believe avacopan has the potential to be a pipeline in a drug and will continue to move our other programs forward."

He also said that "we are encouraged by the data thus far, and intend to initiate a Phase 3 trial in severe Hidradenitis suppurativa (HS) patients in early 2022 and discuss the C3G data with the FDA to determine a potential path forward."

HS is a chronic skin condition characterized by lumps in places such as the armpits or groin.

The skin lesions develop as a result of inflammation and infection of sweat glands.

Schall commented, "with today's FDA approval, we achieved our vision of becoming an integrated biopharmaceutical company with discovery, development, and the U.S. commercial capabilities."

Tavneos (avacopan) is the first new therapy approved in ANCA-associated vasculitis in more than a decade.

ChemoCentryx says it is ready for a fast launch and hopes to make Tavneos available to clinicians and patients in the next few weeks.

Price Action: CCXI shares are up 68.70% at $33.05 during the market session on the last check Friday.