New Drug Company Raises $77.5M to Develop Kidney Disease Treatment

R1 Therapeutics has officially begun operations after securing $77.5 million in Series A funding and obtaining exclusive rights to develop a treatment for elevated phosphate levels in chronic kidney disease patients. The company plans to begin mid-stage trials in early 2026 for their drug AP306, which could offer a simpler alternative to current treatments that have remained largely unchanged for six decades.

A new pharmaceutical company announced Tuesday that it has officially started business with $77.5 million in initial funding and exclusive development rights for a treatment targeting elevated phosphate levels in patients with chronic kidney disease.

R1 Therapeutics obtained the licensing agreement for AP306 from China-based Alebund Pharmaceuticals. The drug is being developed as a standalone treatment for hyperphosphatemia in dialysis patients.

Company CEO Krishna Polu noted that regulatory agencies have “worked hard to identify pathways for accelerated approval of drugs around surrogate endpoints,” which has created increased momentum in kidney treatment development that is attracting more attention from investors and pharmaceutical companies and “provides opportunities to get new medicines to patients faster.”

Surrogate endpoints refer to indirect measurements such as laboratory results or medical imaging that are used in place of direct outcomes like extended life expectancy or improved quality of life.

According to Polu, R1’s primary objective is advancing AP306 into mid-stage clinical trials during the first half of 2026, with results anticipated in the first half of the following year.

Should the trials prove successful, the company expects to begin late-stage development by the conclusion of 2027 and will secure additional funding to support the complete program, handle regulatory filings, and prepare for market launch.

The current funding should support the program through mid-stage testing and initial preparations for late-stage development.

Polu explained that current treatment options have seen minimal changes over the past 60 years and typically require patients to take multiple pills with food, often resulting in digestive issues.

In contrast, AP306 works as a single pill taken two to three times per day by blocking all three known active phosphate transporters in the digestive system, he noted.

R1 plans to handle AP306 commercialization independently in the United States while pursuing partnerships for distribution in Europe, the United Kingdom, and Japan.

Polu mentioned that Medicare’s Transitional Drug Add-on Payment Adjustment, which provides temporary coverage for new dialysis medications while the agency gathers data for future coverage decisions, will support the treatment’s commercial prospects.

The funding round received co-leadership from Carlyle’s Abingworth, DaVita’s Venture Group, and F-Prime, with additional participation from Curie.Bio, SymBiosis, and U.S. Renal Care.