RDX-002(Ardelyx)

September 2, 2015 By Mark Terry , BioSpace.com Breaking News Staff Paris-based Sanofi announced yesterday that it was terminating its option and license with Fremont, Calif.-based Ardelyx for its NaP2b inhibitors. The termination will go into effect Sept. 30, 2015. On Feb. 24, 2014, Ardelyx inked a licensing deal with Sanofi for its NaP2b inhibitor program, also known as NaPi2b, Npt2b and SLC34A2. Ardelyx received $1.25 million upfront, and development and regulatory milestones were projected to hit up to $198 million. There is no payment related to the termination and rights return. NaP2b is an intestinal phosphate transporter which is involved in a major part of dietary phosphate absorption in humans. Inhibiting NaP2b is believed to be useful for the treatment of elevated serum phosphate (hyperphosphatemia) in patients with end stage renal disease (ESRD) and other types of chronic kidney disease (CKD). “We are pleased to regain control over research on NaP2b and look forward to leveraging our knowledge of these inhibitors and their effect on phosphate management as we seek to further understand the mechanisms around phosphate lowering with tenapanor,” said Jeremy Caldwell , executive vice president and chief scientific officer of Ardelyx in a statement. “Importantly, we can now deepen our understanding of NaP2b effects utilizing our proprietary research capabilities, which was not fully possible under the terms of the Sanofi agreement.” In June of this year, Ardelyx terminated an agreement with AstraZeneca PLC for Ardelyx ’s portfolio of NHE3 inhibitors, including the company’s lead candidate, tenapanor. To terminate the agreement, Ardelyx is paying AstraZeneca $15 million upfront with other contingent payments in the future. The company will also pay $10 million in research and development costs to accelerate the transfer. This deal was originally signed in October 2012. Tenapanor inhibits NHE3, a molecule that transports sodium in the gastrointestinal tract. Clinical trials have shown that it cuts the absorption of dietary sodium and phosphorus in the intestinal tract. Last year, in October 2014, the company reported positive results from a Phase IIb trial of tenapanor in treating patients with irritable bowel syndrome with constipation (IBS-C). In a recent second quarter financial report the company indicated that tenapanor is being investigated in two separate clinical trials. “We have made significant progress towards our goal of becoming a fully-integrated bio-pharmaceutical company,” said Mike Raab , president and chief executive officer in a statement. “Under our leadership, tenapanor’s clinical development is accelerating, with a Phase III clinical program in IBS-C and a Phase IIb dosing trial in hyperphosphatemia patients on dialysis planned to begin in the fourth quarter of 2015. Our recent financing gives us the financial strength to initiate these late stage clinical programs and continues to pursue our goal to bring several compounds from the clinic to commercialization.” Raad’s comment about recent financing refers to a June 3 announcement that Ardelyx had agreed to sell shares of its common stock and warrants in a private placement totaling about $77.8 million. The company’s largest shareholders, New Enterprise Associates (NEA) , agreed to invest $50.2 million in the deal. The remaining $27.6 million would be invested by a combination of new and existing investors, including RA Capital Management , Broadfin Capital LLC , Cormorant Asset Management LLC , Foresite Capital Management, LLC , Rock Springs Capital Management LP , and a fund managed by Sabby Capital, LLC .