Pathalys Pharma secures $105M in financing to finalize clinical trials
Pathalys Pharma, fresh off raising an additional $105 million, is poised to finalize clinical trials and pursue regulatory approval for its treatment for patients with end-stage kidney disease.
The Research Triangle Park biopharmaceutical company announced its Series B financing round this week. It’s the second significant financing round in less than two years for Pathalys, adding to the $150 million raised in early 2023 to support phase 3 trials for its primary drug candidate, upacicalcet.
Upacicalcet is a treatment for dialysis patients diagnosed with secondary hyperparathyroidism (SHPT). The condition occurs when the parathyroid glands, located behind the thyroid, release too much hormone to make up for low calcium levels. It can cause bone disease and calcium buildup in tissues.
“Since our inception, Pathalys has made significant strides toward our goal of delivering a best-in-class treatment for those with end-stage kidney disease (ESKD), including the near completion of two phase 3 clinical trials for upacicalcet,” Pathalys CEO Neal Fowler said in a statement.
New calcimimetic treatment
Upacicalcet, administered intravenously, is intended as an improved calcimimetic treatment for SHPT. Calcimimetics mimic the action of calcium on tissues by binding to the parathyroid’s calcium-sensing receptor.
Pathalys owns exclusive rights to develop and commercialize upacicalcet outside Japan and Asia. The treatment has been approved for dialysis patients in Japan.
The company enrolled its first patients in two identical phase 3 trials for upacicalcet in May 2023. With the new financing, the company said it plans to complete these trials, file a new drug application (NDA) with the U.S. Food and Drug Administration, and accelerate its commercialization planning.
“With both upacicalcet trials on track for early completion, we are hopeful that these efforts will support a near-term NDA filing with the FDA,” Chen Yu, M.D., founder and managing partner of Pathalys investor TCG Crossover (TCGX), said in a statement. Yu has joined the Pathalys board of directors with the TCGX investment in the company.
Investors added
Pathalys said the new financing round was oversubscribed. TCGX, based in Palo Alto, Calif., served as lead investor.
The round included several investors not listed in Pathalys’s Series A financing, including JP Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment, and JPS Growth Investment Limited Partnership. Pathalys said its founding investors, Catalys Pacific and DaVita Venture Group, also participated.
Pathalys was founded in March 2022. Fowler is the former CEO of Morrisville-based Liquidia Corp. and a board member of the North Carolina Biotechnology Center.