North Carolina biotech Pathalys Pharma expects to do a rare thing with its nine-figure Series B: file for FDA approval.
Whereas most Series B financing rounds get a biotech into Phase 1 or through mid-stage proof-of-concept studies, Pathalys is already running two Phase 3 trials of its experimental drug for certain forms of end-stage kidney disease.
It anticipates that the $105 million raise, disclosed Tuesday, can take it through an NDA filing and support the work needed to prepare for commercialization.
The two late-stage studies, PATH-1 and PATH-2, are slated for completion next July, according to the federal clinical trials database. In a statement, Pathalys CEO Neal Fowler said the trials are “near completion.” He joined in 2022 after leading another North Carolina biotech, the pulmonary hypertension drugmaker Liquidia.
With the help of Abingworth’s Launch Therapeutics, Pathalys is testing an IV-delivered calcimimetic known as upacicalcet for hemodialysis-dependent patients with secondary hyperparathyroidism, or SHPT. In patients with SHPT, the parathyroid glands go into overdrive.
If successful, Pathalys will go up against Amgen. Its drug Parsabiv secured FDA approval for SHPT in February 2017, and the medicine brought in $106 million in the second quarter, a 22% year-over-year rise, the California biopharma said this month. In 2004, Amgen also won FDA approval for another SHPT calcimimetic marketed as Sensipar.
Other drugmakers are making moves in various kidney diseases, with a particular emphasis in IgA nephropathy, an autoimmune disease that impairs the kidney.
TCGX led the Series B for the Research Triangle Park-based Pathalys. JP Morgan Life Sciences Private Capital also took part, as did Samsara BioCapital, Marshall Wace, KB Investment, JPS Growth Investment Limited Partnership and others.
Chen Yu“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,” TCGX founder Chen Yu said in a statement. He joined the board alongside Joe Siletto, who recently became a co-managing partner of JP Morgan Life Sciences Private Capital.
Pathalys was co-founded by Japanese VC group Catalys Pacific and the corporate venture arm of kidney healthcare provider DaVita.
It marks the 64th megaround for private biotechs so far this year, according to an Endpoints News tally.