Unicycive Therapeutics has hit a bump on the road in its mission to bring its hyperphosphatemia treatment candidate to patients with chronic kidney disease (CKD) who are on dialysis.
The FDA issued the company a complete response letter (CRL), citing issues at a third-party manufacturing vendor flagged during a recent inspection. The agency did not note any concerns with the company’s safety or clinical data, nor any technical concerns relating to the documentation or testing of the oxylanthanum carbonate (OLC) product in question, California-based Unicycive said in a June 30 press release.
Unicycive has already lined up a second manufacturer that had been meant to serve a back-up vendor to “build redundancy" into the biotech's supply chain, according to the release.
That manufacturer has a “long history” of successful regulatory inspections and has already produced OLC drug product, boosting Unicycive’s hopes that it can resolve the manufacturing issues flagged in its drug application.
“With a second manufacturing vendor identified that has produced OLC drug product, we remain optimistic about our ability to bring this promising new treatment option to patients with CKD on dialysis who are managing hyperphosphatemia, and we plan to provide an update as soon as we have additional clarity on next steps from the FDA,” the company’s CEO Shalabh Gupta, M.D., noted in the release.
Unicycive will seek a meeting with the FDA to “gain alignment on the best strategy to ensure rapid resolution of the CRL,” Gupta added.
The FDA alerted the drugmaker about the manufacturing issues earlier this month. The citations at the third-party manufacturer weren’t related to OLC manufacturing specifically, the biotech said.
OLC is an oral phosphate binder made using Unicycive’s nanoparticle technology to reduce the number and size of pills needed for hyperphosphatemia treatment.
Hyperphosphatemia is a serious condition entailing too much phosphate in the blood and is found in nearly all patients with end stage renal disease. Over 450,000 people in the U.S. require medication to control their phosphate levels annually, according to Unicycive. Treatment usually requires oral phosphate binding drugs daily with each meal; untreated hyperphosphatemia is linked with increased death and hospitalization rates for CKD patients on dialysis.
The OLC med is kidney disease-focused Unicycive’s lead pipeline asset. The company is also testing a phase 1 prospect for acute kidney injury.