FREMONT, Calif.—Ardelyx, Inc. has announced the closing of aSeries B preferred stock financing today, one which has netted the company atotal of $30 million. The financing round's participants included Ardelyx'sprevious investors NEA, CMEA and certain other individual investors, inaddition to a new investor, Amgen Ventures, LLC.
The proceeds are slated to beused to advance the company's pipeline, which currently includes three productcandidates: RDX5791, a clinical-stage product intended for treating constipation-predominantirritable bowel syndrome (IBS-C) and for preventing excess dietary sodiumabsorption; RDX002, a preclinical product indicated for chronic kidney disease;and RDX009, another preclinical candidate indicated for the treatment of type 2diabetes. The company is focused on the development of non-absorbed smallmolecules that function within the intestines to influence systemic functionswithin the gastrointestinal, cardio-renal and metabolic fields.
The funds gained from the financing round will be used tocomplete the phase II clinical trial of RDX5791 in patients suffering fromIBS-C and a dose-ranging/regimen study of RDX5791 to optimize its potential toprevent excess dietary sodium absorption, a treatment modality intended to controlhypertension. The studies are both slated for completion in early 2012.
"This phase 2 trial data evaluating RDX5791 in patients withconstipation-predominant irritable bowel syndrome are strategically importantto Ardelyx because they will be our first efficacy results in a disease withsignificant unmet needs and an important demonstration of our unique approachto drug development," Mike Raab, Chairman and CEO of Ardelyx, said in a pressrelease.
RDX5791 is a potent NHE3 sodium transport inhibitor, and ifdevelopment is successful, it will be a first-in-class product in the field ofintestinal sodium blockade. The product works to prevent the absorption ofsodium, allowing it to instead be retained within the gastrointestinal tract,thereby normalizing the fluid balance in order to treat constipation and IBS-C.At a different dosing level than the one utilized in the phase I trial, Ardelyxexpects that RDX5791 will also be useful in preventing the absorption of extradietary sodium, emulating a low-sodium diet, and might also represent a newtreatment modality for hypertension (high blood pressure.)
The other two products that will benefit from the fundingsecured by the Series B round are both in the preclinical stage. RDX002 is anon-absorbed NaP2b phosphate transport inhibitor intended as a small moleculeinhibitor of intestinal phosphate transport for patients with chronic kidneydisease, and has been shown to work with phosphate binders to dramaticallylower phosphate absorption, which could help to delay or prevent theprogression of chronic kidney disease. RDX009 is a non-absorbed TGR5 agonist,and TGR5 is well known as an important target for treating type 2 diabetes. Anon-absorbed drug that could stimulate the receptor in the intestines could haveefficacy and safety advantages over the current agents.
"Given the significant opportunities in our pipeline, ournext priority is to establish partnerships in the US and abroad to advance ourprograms," said Raab.
SOURCE: Ardelyx, Inc. press release