Ardelyx cuts 28% of staff in pipeline shake-up
- 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.
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.
- Ardelyx Press release
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