Ardelyx Inc. (NASDAQ:ARDX)
Ardelyx Inc. (NASDAQ:ARDX) has lost ground in the market ever since it reported data from its Phase III study for its lead asset tenapanor. The sudden change in investor sentiments comes even though the drug met its primary endpoints and performed well against seven of the eight secondary points in the first stage of the two planned Phase III trials.
Positive Clinical Results
Tenapanor is a drug being developed as a novel treatment for irritable bowel syndrome with constipation or IBS-C. The medical condition has a significant market in the U.S. – over 11 million people suffer from the condition. Yet despite the positive outcomes, the stock has curiously shed 40% in market value.
Ardelyx Inc. (NASDAQ:ARDX)’a drug candidate is designed to stop the body from removing sodium in the gastro-intestinal tract. Increased level of sodium in the gut goes a long way to loosen stool and, therefore, relieving constipation. During the trials, Tenapanor successfully reduced abdominal pain by 30% and also resulted in an increase in spontaneous bowel movements.
“In this trial, tenapanor demonstrated clinical activity across a large number of study parameters and had a favorable safety profile consistent with previous clinical experience. With a differentiated mechanism of action, we believe tenapanor has the potential to augment the care of patients with IBS-C,” said CEO, Mike Raab.
Data from the trials also shows a good number of patients treated with tenapanor hit the primary endpoint compared with those on a placebo – 27% vs. 18.7%.
One of the main reasons why investors sent the stock crumbling in the market may have to do the safety and tolerability aspect of the drug. When it comes to tenapanor, just like other drugs used to treat irritable bowel syndrome, diarrhea is always a big concern. The drug will have to find a balance between the medical condition and resolution if it is to combat its largest side-effect – diarrhea.
According to the study, 14.6% of the patients who took tenapanor got diarrhea with 5.9% opting to go off the drug due to this side effect. While the number looks pretty good when compared to Ironwood’s Linzess, the same cannot be said when compared to Synergy Pharmaceuticals Trulance.
The fact that Ardelyx Inc. (NASDAQ:ARDX) is competing with Synergy and Ironwood means it will have to significantly reduce the side effects of its candidate drug if it is to prevent further downturn.
Ardelyx Inc. (NASDAQ:ARDX) was down by 7.07% in Friday’s trading session and ended the week at $4.60 a share.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
About the author: James Marion is a University of Houston student studying Business with a concentration in Finance