Pathalys Pharma has secured $105m in a Series B financing round to support its clinical trials, file a new drug application (NDA) with the US Food and Drug Administration (FDA), and accelerate preapproval commercialisation preparations.

The company’s lead candidate is upacicalcet, a drug used to treat secondary hyperparathyroidism (SHPT) in patients undergoing dialysis due to chronic kidney disease (CKD). The calcimimetic drug mirrors the action of calcium on tissues, particularly the parathyroid glands. The medication is typically administered during dialysis sessions.

Earlier this year, Pathalys launched two identical Phase III studies of upacicalcet, which will both enrol 375 patients. The PATH study program is designed to assess the efficacy of upacicalcet as measured by its ability to reduce intact parathyroid hormone (iPTH) by 30% or more in participants with SHPT and currently on haemodialysis.

The funding round, led by TCGX, is set to support these clinical trials, and advance the candidate towards approval. The drug is already approved to treat SHPT in Japan, securing the green light in 2021. Others included in the round were JP Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment, JPS Growth Investment Limited Partnership, Catalys Pacific, and DaVita Venture Group.

SHPT is a condition where the parathyroid glands, which are small glands located in the neck, produce excessive amounts of PTH. This overproduction occurs as a response to low calcium levels in the blood. The most common cause of this is chronic kidney disease (CKD). As the kidneys fail, they are less able to convert vitamin D into its active form, which is necessary for calcium absorption.

The first approved calcimimetic drug was Amgen’s Sensipar (cinacalcet). Similar to upacicalcet, it lowers PTH levels by increasing the sensitivity of the parathyroid gland to calcium. Amgen also has Parsabiv (etelcalcetide) in its portfolio, which is delivered intravenously during dialysis sessions. Parsabiv pulled in $362m in sales for Amgen in 2023, as per the company’s financials.

In the announcement accompanying the funding, Pathalys’s CEO Neal Fowler said: “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 III clinical trials for upacicalcet.”

“We believe the continued expansion of our syndicate of prominent life science investors, with representative board members, is indicative of the fact that we are on the right path at Pathalys.”

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