Renibus Therapeutics Announces FDA Orphan Drug Designation for Veverimer for the Treatment of Anti-glomerular Basement Membrane Disease (anti-GBM)

SOUTHLAKE, Texas, June 10, 2025 /PRNewswire/ -- Renibus Therapeutics® ("Renibus"), announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to veverimer for the treatment of anti-glomerular basement membrane disease (anti-GBM), an ultra-rare life-threatening condition characterized by acute renal failure associated with the presence of auto-immune antibodies with affinity for the glomerular basement membrane.   

"Ultra-rare life-threatening conditions, including anti-GBM and several other forms of glomerular and tubulointerstitial kidney diseases, can be aggressive and challenging to treat effectively with current therapies," said Bhupinder Singh M.D., Chief Medical Officer of Renibus.  "This Orphan Drug Designation further underscores the potential of veverimer to offer a significant advantage beyond drugs currently used to treat kidney disease, and we look forward to advancing this asset in the clinic."

The Orphan Drug Designation program is intended to encourage the development of products for diseases that affect fewer than 200,000 individuals in the United States. With this designation Renibus is eligible for certain incentives, such as tax credits for clinical trials, exemption from user fees, and a potential 7 years of market exclusivity upon approval.

Richard Zager, Senior Vice President of Translational Research of Renibus, commented, "Veverimer markedly suppresses ammoniagenisis and associated activation of the complement cascade, which are key mediators of anti-GBM disease and other complement mediated renal diseases.  We are continuing to evaluate the potential of veverimer to address these diseases of high unmet medical need."

About Renibus Therapeutics

Renibus is a clinical stage biopharmaceutical company dedicated to treating, improving, and extending patients' lives by developing products to prevent disease progression, improve outcomes and protect against organ damage associated with cardio, renal and metabolic diseases.   

Renibus' lead first-in class combination drug therapy is RBT-1 (stannic protoporfin / iron sucrose), a single dose IV drug that is given over 1-2 hours, 24-48 hours prior to patients undergoing elective cardiac and/or valve surgery.  RBT-1 has just completed enrollment in a Phase 3 pivotal trial (called PROTECT) measuring its primary objective to reduce the risk of post operative complications and improve outcomes following cardiac surgery. The drug has been granted FDA Breakthrough and Fast Track Designations by the Division of Cardiology and Nephrology at the FDA.

Veverimer is an oral, non-absorbed hydrochloric acid binder that has been granted Orphan Drug Designation for the treatment of anti-glomerular basement membrane disease. Renibus is also evaluating veverimer's potential use for the treatment of other renal diseases.

For more information, please visit the Company's website at www.Renibus.com and engage with us on LinkedIn.

Investor and Media Contact:
Amy Conrad
Juniper Point
[email protected]
858-914-1962

Business Development Contact
Jamie Donadio
CFO, Renibus
[email protected]

SOURCE Renibus Therapeutics