Dive Brief:
- Ardelyx, Inc. unveiled a restructuring plan for its pipeline alongside its second quarter earnings announcement Wednesday, putting more emphasis on the company’s late-stage assets.
- After a strategic review, the company has decided to delay several early stage programs and cut 28%, or about 30 employees, of its workforce. The cuts will come from R&D and general administration, and will be completed by November.
- The restructuring will cost the company $800,000 in a one-time charge during the third quarter and will extend the biotech's cash runway to the end of 2018. As of June 30, Ardelyx had $148.7 million in cash and equivalents.
Dive Insight:
This wasn't the first signs of trouble for Ardelyx.
The company's lead drug candidate, tenapanor, has shown some mixed results in trials. In 2015, the drug failed in a Phase 2 study of chronic kidney disease patients, prompting big pharma partner AstraZeneca to drop the drug.
Separately, that year Sanofi opted out of a partnership with the company originally signed in 2014 for some early-stage assets.
Ardelyx will now focus all its resources and attention on two Phase 3 assets: tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C) and hyperphosphatemia, as well as RDX7675 for the treatment of hyperkalemia.
Tenapanor recently completed one Phase 3 study in IBS-C which showed a statistically significant improvement in symptoms over placebo at the end of 12 weeks.
The drug is now being studied in two other ongoing Phase 3 trials for the condition, with results from the first expected sometime in the fourth quarter. Ardelyx plans to submit a New Drug Application for the drug in IBS-C next year.
Tenapanor has also completed its first late-stage study in hyperphosphatemia patients with end-stage renal disease. Based on the results, the company has sought advice from the Food and Drug Administration on the design and implementation of the second Phase 3 study in the condition.
A planned study for RDX7675 in hyperkalemia will begin once the trials for tenapanor in IBS-C have been completed.