March 17 (Reuters) – R1 Therapeutics said on Tuesday it had launched operations with a $77.5 million Series A funding round and an exclusive license to develop and commercialize a drug for high phosphate levels in chronic kidney disease patients.
The company licensed AP306, being developed as a monotherapy for hyperphosphatemia in patients on dialysis, from China‑based Alebund Pharmaceuticals.
Chief Executive Krishna Polu said regulators have “worked hard to identify pathways for accelerated approval of drugs around surrogate endpoints,” creating momentum in kidney therapeutics that is drawing greater interest from investors and drugmakers and “provides opportunities to get new medicines to patients faster.”
Surrogate endpoints are indirect measures — like lab tests or imaging — used instead of outcomes such as living longer or feeling better.
R1’s immediate focus is to move AP306 into a mid-stage trial in the first half of 2026, with data expected in the first half of next year, Polu said.
If successful, the company plans to start late-stage development by the end of 2027, and will raise capital to fully fund the program, carry out regulatory submissions and launch early.
The current round should carry the program through mid-stage and initial late-stage preparations.
Polu said existing treatments have changed little in 60 years and often require multiple pills with meals and cause stomach problems.
AP306 is a single pill taken two or three times daily by shutting down all three known active phosphate transporters in the gut, he added.
R1 intends to commercialize AP306 in the U.S. by itself, and seek partners in Europe, the UK and Japan.
Polu said Medicare’s Transitional Drug Add‑on Payment Adjustment, which temporarily pays for new dialysis drugs while the agency collects data to decide future coverage, will be supportive of the therapy’s commercial opportunity.
The funding round was co‑led by Carlyle’s Abingworth, DaVita’s Venture Group and F‑Prime, with Curie.Bio, SymBiosis and U.S. Renal Care also participating.
(Reporting by Puyaan Singh in Bengaluru and Bhanvi Satija in London; Editing by Maju Samuel)
Comments