By Puyaan Singh and Bhanvi Satija
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 ( DVA ) Venture Group and F-Prime, with Curie.Bio,
SymBiosis and U.S. Renal Care also participating.