Tricida Inc. raised a $55 million series C to support continued development of its chronic kidney disease (CKD) compound, TRC101. The round propelled the South San Francisco-based biopharma to $95 million in funding since its founding in 2014 and positioned it to complete a phase I/II proof-of-concept study for TRC101 and prepare for a type B meeting with the FDA this year.

Company management has deep experience in handling scientific and financial assets. Tricida is the third venture for the team, which took Ilypsa Inc. from start-up to a $420 million acquisition by Amgen Inc. on the strength of a phase II CKD asset before replicating the experience at Relypsa Inc., where they moved Veltassa (patiromer) through phase III development. (See BioWorld Today, June 6, 2007, and May 14, 2013.)

Veltassa was approved by the FDA last year to treat high blood potassium. Although a boxed warning that the oral potassium binder should not be taken within six hours of other oral drugs was expected to dent sales, in May would-be competitor Astrazeneca plc received a complete response letter for sodium zirconium cyclosilicate, its oral suspension candidate, gained in the London-based pharma's 2015 acquisition of ZS Pharma Inc. for $2.7 billion. (See BioWorld Today, Oct. 23, 2015, and May 31, 2016.)

Last week, Galenica Group, the parent of Vifor Pharma Ltd., struck a $1.53 billion deal to purchase Relypsa and gain global rights to Veltassa. Vifor already holds rights to Veltassa outside the U.S. and Japan. (See BioWorld Today, July 22, 2016.)

Gerrit Klaerner, Tricida's president and CEO, told BioWorld that the team's track record, along with strong interim data from its fully enrolled study of TRC101 in 100 CKD patients and support from existing investors Orbimed Advisors, Sibling Capital Ventures and Limulus Venture Partners, enabled the oversubscribed series C to gel quickly, led by new investor Longitude Capital with participation from new investor Vivo Capital.

In conjunction with the financing, David Hirsch, managing director at Longitude, joined Tricida's board.

The financing will extend the company's runway through 2018, Klaerner said, allowing the company to begin a late-stage trial of TRC101 and accumulate additional data on the non-absorbed drug, designed to treat electrolyte imbalances in patients with CKD and slow the overall progression of the disease, thus reducing the number of patients who require dialysis.

The company has not disclosed the target or mechanism of action.

"Once we get the 100-patient data later this year, we're going to explain a little bit more about what we're doing in CKD," Klaerner promised.

'SMALL COMPANIES SHOULD DO ONE THING & DO IT RIGHT'

Despite several decades working to advance therapies in the CKD field, "there's still a very significant need to improve the outcomes in this population," he maintained. "They're mostly diabetics with high blood pressure, and they're on a very clear path to requiring dialysis."

Understanding Tricida's mission, in fact, requires little more than revisiting the Ilypsa and Relypsa business plans. Like the predecessor companies, Tricida is focused on a single asset that it can take through approval and potentially to market with its own sales force if a buyer doesn't come along beforehand.

"I believe that small companies should do one thing and do it right," Klaerner explained.

Although Tricida will seek initial guidance on a pivotal program from the FDA, the company has global plans for TRC101.

"Shortly after the FDA interaction, we're going to talk with other regulatory authorities," Klaerner said.

Less than three years from its formation, the company numbers approximately 30 employees "across all the disciplines needed for drug development," he added. "The idea is to run a late-stage trial, and we'll grow accordingly to facilitate that."

In addition to Klaerner, who also co-founded Ilypsa and Relypsa, other principals with ties to one or both former companies include Jerry Buysse, chief scientific officer and senior vice president, and Claire Lockey, chief development officer and senior vice president.

The company's senior staff also is peppered with Ilypsa and Relypsa alumni.

Ilypsa was snagged while still privately held, and Klaerner's team positioned Relypsa for an IPO by raising approximately $183 million in three private equity rounds. Relypsa filed for its IPO in September 2013, four months after naming John Orwin as president and CEO, and pulled the trigger on the offering in November 2013. (See BioWorld Today, Oct. 1, 2013, and Nov. 18, 2013.)

Tricida raised a $10 million series A in 2014 and a $30 million series B last year, but Klaerner was coy about the company's future financing ambitions.

Orbimed is the largest investor in the company's established syndicate of "very sophisticated investors," he said, noting that the addition of Longitude and Vivo "give us very good access to capital and allow us to take an iterative approach. We'll look at our 100-patient data, we'll get the FDA feedback and then we can plot our path forward to fully fund our late-stage trials."