Pathalys Pharma, Inc. and Launch Therapeutics (Launch Tx) have announced a collaboration to advance phase 3 clinical trials for upacicalcet (designated PLS240 for clinical trials) for the treatment of secondary hyperparathyroidism (SHPT) in patients on hemodialysis.
Launch Therapeutics is backed by funds managed by global investment firm Carlyle and its life sciences franchise Abingworth.
Pathalys Pharma also announced it has raised $150 million through a combination of secured product financing and equity to support the two phase 3 clinical trials, registration efforts and pre-commercialization activities for upacicalcet.
Abingworth led both financings and was joined by Carlyle and OrbiMed, along with Pathalys’ founding investors Catalys Pacific and DaVita Venture Group. Pathalys retains worldwide commercial rights to upacicalcet, outside Japan and Asia, and has the option to prepay its obligations in full at any time.
“Pathalys is very excited to collaborate with Launch Tx and to have the backing of such an esteemed group of healthcare investors. Through this collaboration and transaction, Pathalys expects to be fully funded through the completion of its planned phase 3 trials, and pre-commercialization efforts for upacicalcet,” said Neal Fowler, chief executive officer at Pathalys.
“We look forward to working closely with Launch Tx to advance upacicalcet toward registration in the U.S. with the goal of making this important product candidate available for dialysis patients with SHPT.”
The co-development agreement creates a collaboration that combines the exceptional clinical development resources available through Launch Tx and the extensive dialysis expertise of Pathalys to advance the upacicalcet clinical development program. Launch Tx will have the lead role in the operational execution and management of the planned clinical trials and Pathalys will retain primary responsibility for manufacturing, FDA regulatory interactions and commercialization.
Anshul Thakral, CEO of Launch Therapeutics, added: “We are thrilled to collaborate with Pathalys to advance upacicalcet. Launch Tx will bring deep clinical and operational resources to this phase 3 program to accelerate the path to regulatory approval. We offer a unique approach that helps both pharma and biotech companies develop their late-stage therapies and plan to demonstrate that approach through our collaboration with Pathalys.”
Earlier this year, Pathalys Pharma announced plans to initiate two phase 3 clinical trials to evaluate upacicalcet as a treatment alternative to currently available calcimimetics. Upacicalcet is a novel calcimimetic that performed well in phase 3 studies in Japan where it was approved last year for the treatment of SHPT in patients on dialysis.
An intravenous calcimimetic like upacicalcet may allow patients on dialysis better control of serum parathyroid hormone levels in SHPT in a convenient and compliant way, without increasing their calcium-phosphorus production while, more importantly, lowering their risk for vascular calcifications.
Upacicalcet is an intravenously administered investigational small molecule calcimimetic that may control intact parathyroid hormone (iPTH) levels in patients with secondary hyperparathyroidism (SHPT) receiving hemodialysis. Upacicalcet was granted Marketing Authorization in Japan in 2021, under the brand name UPASITA, based on a phase 3, 24-week double-blind, placebo-controlled dose-titration study and a second phase 3, 52-week open-label, dose-titration study.
In these studies, upacicalcet was shown to significantly reduce iPTH and maintain long-term iPTH suppression, as well as demonstrate the potential for fewer adverse events (AEs) than currently available therapies.
About Pathalys Pharma
Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company developing multiple advanced therapeutics that address unmet needs in the management of end-stage kidney disease (ESKD). Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys was co-founded by Catalys Pacific and DaVita Venture Group and is headquartered in Research Triangle Park, North Carolina.