Ardelyx cuts a third of its workforce following a surprise FDA rejection – PharmaLive

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July 29, Fremont, Calif. And Waltham, Mass. Ardelyx has received a full response letter (CRL) from the United States Food and Drug Administration (FDA) for its new drug application (NDA) for tenapanor for the control of serum phosphorus in adults with chronic kidney disease (CRF) on dialysis. Now the company is restructuring to save money, which will include cutting 83 jobs, or about a third of its staff.

Ardelyx says the restructuring plan will save $ 17 million in annual cash compensation, although there will be a restructuring charge of around $ 3.4 million. The changes will mainly be registered in the third quarter. At the end of 2020, Ardelyx had 129 full-time employees. He also declared an accumulated deficit of $ 588 million. At the end of the first quarter, in March 2021, it reported $ 178 million of cash, cash equivalents and short-term investments.

The company’s shares traded as high as $ 9.23 last year, but as of Tuesday, August 3, the shares were trading at $ 1.61 per share.

Ardelyx reported that the FDA has declared its willingness to meet with the company and has requested a Type A meeting. CRL said the company should “conduct an additional adequate and well-controlled trial demonstrating a clinically relevant treatment effect. on serum phosphorus or an effect on the clinical outcome thought to be caused by hyperphosphatemia in CKD patients on dialysis ”. Otherwise, there were no safety, clinical pharmacology / biopharmaceutical, CMC or non-clinical issues.

Source: BioSpace

The NDA for the drug was supported by a development program that included more than 1,000 patients and three Phase III trials. All met their primary and secondary endpoints.

Arnold Silva, MD, Ph.D., director of clinical research at the Boise Kidney and Hypertension Institute, said, “Reducing serum phosphorus is a priority for me in the management of my dialysis patients, and is a standard of established care, peer-led. -Reviewed KDIGO’s globally accepted clinical practice guidelines. Years of research have demonstrated the negative consequences associated with even slight elevations in serum phosphorus. Despite our best efforts with currently available therapies, phosphorus management remains a significant challenge. We need new tools. I have followed the in-depth clinical development of tenapanor closely, not only as an interested nephrologist, but also as a clinical researcher. I have seen the clinical benefits of tenapanor firsthand in my patients and am amazed that the FDA will not grant approval for this new mechanism drug, despite extensive clinical data demonstrating its safety and effectiveness.

Although the trials all met their primary and secondary endpoints, however, they focused on biomarkers, reduction in phosphate levels, rather than clinical outcomes. In addition, 16% of patients in the most recent study dropped out because of diarrhea.

The drug was approved as Ibsrela in September 2019 for the treatment of irritable bowel syndrome with constipation. The drug is a small, poorly absorbed molecule that works in the gastrointestinal tract by inhibiting NHE3 sodium-hydrogen exchange. This causes increased bowel movements and decreased abdominal pain in these patients.

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