#United States #Denver #ASN Kidney Week #Pathalys Pharma #upacicalcet

Pathalys Pharma Showcases Exciting Phase 3 Trial Results

At the recent ASN Kidney Week 2026 held in Denver, Colorado, Pathalys Pharma, a U.S.-based biopharmaceutical company, unveiled promising results from its pivotal Phase 3 trials focusing on upacicalcet, an investigational calcimimetic therapy aimed at patients suffering from secondary hyperparathyroidism (SHPT) related to end-stage kidney disease.

The presented data was part of the studies named PATH-1 and PATH-2, which assessed the safety and efficacy of upacicalcet in conjunction with hemodialysis treatments. Both trials were exemplary in meeting their primary and key secondary endpoints, focusing specifically on the reduction of parathyroid hormone (PTH) levels. The results signify a significant progression in the management of SHPT, a condition that complicates the health of almost all dialysis patients and leads to severe complications such as fractures and cardiovascular issues.

During the featured oral presentation entitled Efficacy and Safety of Upacicalcet in Hemodialysis Patients with SHPT: Two Randomized Clinical Trials (RCTs), the company reported striking findings: a substantial percentage of participants in both trials achieved at least a 30% reduction in intact PTH levels compared to placebo, aligning with the treatment goals recommended by the National Kidney Foundation. Specifically, 42.1% of participants in PATH-1 and 43.5% in PATH-2 reached this significant reduction.

Alongside the primary objectives, upacicalcet also successfully met several secondary endpoints, demonstrating its ability to lower PTH levels sufficiently and achieve target ranges established by clinical guidelines. This represents a breakthrough for patients seeking more effective management of SHPT, marking a step forward from traditional methods that have previously limited success and posed substantial risks.

Dr. Jessica Kendrick, the Principal Investigator from the University of Colorado Anschutz, highlighted the importance of these findings, emphasizing the critical need for new treatment solutions to improve health outcomes for patients enduring the complexities of chronic kidney disease and its associated challenges. The studies demonstrated that upacicalcet, administered as an intravenous treatment during hemodialysis sessions, delivers beneficial results while maintaining a tolerable safety profile when compared to placebo.

While gastrointestinal adverse events were reported, they were consistent between treatment and placebo groups. Importantly, serious adverse events were also notably similar across both arms, indicating that upacicalcet is generally well-tolerated among patients undergoing hemodialysis. Noteworthy was the incidence of asymptomatic hypocalcemia, a condition that warrants monitoring, but was manageable within the context of the study protocols.

The data from these trials resonates with a broader mission at Pathalys — to address the urgent needs of nearly half a million patients in the U.S. receiving hemodialysis, including those who suffer from SHPT. Bastian Dehmel, Chief Medical Officer at Pathalys, remarked, "The need for new and approved treatment approaches is both significant and urgent, particularly as SHPT poses serious risks for patients with kidney failure. Our work with upacicalcet reflects our commitment to innovation in treating kidney disease challenges."

In addition to the oral presentation, Pathalys also showcased further findings in poster sessions at Kidney Week, which underscored upacicalcet's potential in improving markers associated with chronic kidney disease-mineral and bone disorder (CKD-MBD), reinforcing the broader therapeutic implications of this investigational product.

Overall, the outcomes of the PATH-1 and PATH-2 studies position upacicalcet as a promising candidate for advancing the management of SHPT and offering a new hope for thousands of patients suffering from chronic kidney disease. As Pathalys moves forward in its research and development efforts, the nephrology community and those affected by end-stage kidney disease are encouraged to stay tuned for future developments that could change the landscape of patient care.

Pathalys, founded in 2021, continues to focus on innovative solutions to meet the various challenges faced by individuals living with chronic kidney disease. For more information about their initiatives, visit PATHALYS.com.