Pathalys Pharma, the Research Triangle Park-based biopharmaceutical company developing therapies for end-stage kidney disease, has secured $150 million in new financing to support phase 3 clinical trials for its leading drug candidate.
Abingworth, a life sciences investment firm owned by global investment firm Carlyle, led the financing. As part of the deal, announced Wednesday, Pathalys will collaborate with a clinical development company backed by Carlyle to support phase 3 trials for upacicalcet – Pathalys’s treatment for dialysis patients diagnosed with a condition that causes the parathyroid glands to overwork.
The financing marks a significant milestone for Pathalys. The company launched in March 2022 with backing from Catalys Pacific and DaVita Venture Group. It’s headed by Triangle biopharma veteran Neal Fowler, the former CEO of Morrisville-based Liquidia Corp., which focuses on therapies for pulmonary arterial hypertension. Fowler is also a former North Carolina Biotechnology Center board member.
The collaboration with Carlyle-backed Launch Therapeutics (Launch Tx) is expected to give Pathalys funding through completion of phase 3 trials for upacicalcet, which will treat secondary hyperparathyroidism (SHPT), Fowler said in a statement.
“Pathalys is very excited to collaborate with Launch Tx and to have the backing of such an esteemed group of healthcare investors,” he said. “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.”
Treatment for parathyroid condition
SHPT is a condition in which the parathyroid glands, small glands located behind the thyroid, produce high levels of parathyroid hormone to make up for low calcium levels in the body. According to the Mayo Clinic, chronic kidney failure is the most common cause of SHPT.
Pathalys is commercializing upacicalcet as an alternative to current treatments known as calcimimetics, which are compounds that bind to the calcium-sensing receptor in the parathyroid. The company bought the exclusive development and commercialization rights to upacicalcet globally outside Japan and Asia.
Upacicalcet, administered intravenously, was shown to be effective in treating SHPT in phase 3 studies in Japan.
Path to approval
Under its agreement with Launch Tx, Pathalys will lead the FDA regulatory process, manufacturing and commercialization of upacicalcet. Launch Tx will focus on clinical trials management and operations.
“We are thrilled to collaborate with Pathalys to advance upacicalcet,” Launch Tx CEO Anshul Thakral said in a statement. “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.”
Carlyle, OrbiMed, and Pathalys’s founding backers Catalys Pacific and DaVita Venture Group joined Abingworth in the financing. The $150 million total is through a combination of secured product financing and equity.
Original Article Source: NC Biotech