Research Triangle Park, North Carolina and Boston, Massachusetts, May 31, 2023 – Pathalys Pharma, Inc., a private, late-stage biopharma company co-founded by Catalys Pacific and DaVita Venture Group, and Launch Therapeutics (Launch Tx), a clinical development company, today announced that the first patient has been enrolled in the PATH (PTH Attenuation Trial in Hemodialysis) clinical program, consisting of two identical phase 3 trials, to assess upacicalcet for the treatment of secondary hyperparathyroidism (SHPT) in end-stage kidney disease (ESKD) patients on hemodialysis.

The PATH clinical trial program is the output of Pathalys’ previously disclosed intent to initiate two identical phase 3 clinical trials to evaluate upacicalcet. Upacicalcet is a novel calcimimetic that performed exceptionally well in phase 3 studies in Japan where it was approved in 2021 for the treatment of SHPT in patients on dialysis.

As part of its strategic collaboration with Pathalys, Launch Tx has the lead role for operational execution and management of the clinical trials and Pathalys has primary responsibility for PATH study design, manufacturing, FDA regulatory interactions, medical oversight, and commercialization.

“We have enrolled our first patient for this program ahead of schedule. With the successful conclusion of this trial, we hope to accelerate upacicalcet toward registration in the U.S. with the goal of making this therapy available for dialysis patients with SHPT.” said Dr. Theodore Danoff, Chief Medical Officer and SVP, Clinical Development at Pathalys. “The advancement of an intravenous calcimimetic like upacicalcet may allow patients on dialysis better control of parathyroid hormone levels in SHPT in a convenient and compliant way while also lowering risk of upper gastrointestinal adverse events and hypocalcemia, which continue to be an issue with current calcimimetics.”

Jessica Kendrick, MD, MPH, the principal investigator (PI) for the studies, commented, “Advancing upacicalcet will be a very meaningful step for patients and enrolling the first patient ahead of schedule is promising given that the sooner we can dose our first patient, the closer we will be to obtaining the needed data for FDA review and hopefully approval.”

“The combination of Pathalys Pharma and Launch Therapeutics is already demonstrating immense value with respect to the speed and efficiency of this program. I firmly believe that the operational expertise and immediate resources provided by the Launch Tx team has contributed to meeting this key milestone ahead of schedule.” said Elisha Talley-Roithner, Head of Operations at Launch Tx.

The PATH study program is designed to assess the efficacy of upacicalcet as measured by its ability to reduce intact parathyroid hormone (iPTH) by 30 percent or more in participants with secondary hyperparathyroidism (SHPT) and currently on hemodialysis.

Each trial will randomize approximately 375 patients (2:1) to upacicalcet or placebo. Eligible patients will be adults receiving in-center hemodialysis three times weekly and whose iPTH values are 450 pg/mL or greater. Upacicalcet will be titrated based on iPTH and serum corrected calcium (cCa) levels with dose steps between 25 and 300 mcg as a bolus IV injection given at the end of a dialysis session. Doses will be titrated to maintain iPTH in the range of 150-300 pg/mL.