Hyperparathyroidism, Secondary

Pathalys has closed a $105m Series B financing round led by TCGX. Credit: PeopleImages.com – Yuri A via Shutterstock. 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. See Also: FDA approves updated mRNA vaccines for Covid-19 Verve Therapeutics gets grant for gene editing compositions to lower ldl cholesterol levels 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.”

Research Triangle Park, North Carolina-based Pathalys Pharma previously brought in $150 million in January 2023 via a combination of secured product financing and equity. Pathalys Pharma has brought in $105 million via a series B fundraise that the kidney-disease-focused biotech will use to take its lead candidate through the final stages of clinical development.The company’s primary focus is upacicalcet, a calcimimetic with the potential to improve the treatment of secondary hyperparathyroidism (SHPT) in hemodialysis patients. Calcimimetics, such as Amgen’s approved SHPT drug Sensipar, mimic calcium's action on tissues in order to treat disorders related to calcium homeostasis or skeletal integrity.In May, Pathalys launched upacicalcet into two identical 375-person phase 3 trials for SHPT. The common, but serious, complication of chronic kidney disease is often seen in patients on hemodialysis. Upacicalcet is already approved for SHPT in Japan, where the drug “performed exceptionally well” in late-stage studies, Pathalys said earlier this year.The new funds will be used to finalize those studies as well as begin the process of preparing an approval submission to the FDA and the “acceleration of preapproval commercialization preparations,” the biotech explained in an Aug. 20 release. The oversubscribed round was led by TCGX with participation from the likes of J.P. Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment and JPS Growth Investment Limited Partnership. Pathalys’ co-founders Catalys Pacific and DaVita Venture Group were also both involved.The financing will see three additions to Pathalys’ board, including Joe Siletto, managing partner of J.P. Morgan Life Sciences Private Capital. “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 the Aug. 20 release.“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,” Fowler added.The Research Triangle Park, North Carolina-based biotech previously brought in $150 million in January 2023 via a combination of secured product financing and equity.

As two pivotal trials of its kidney disease therapy draw to a close, Pathalys Pharma has raised $105 million in a series B to fund a planned new drug application (NDA) submission with the FDA and begin pre-commercialisation activities. Led by TCGX, the round also saw participation from JP Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment, and JPS Growth Investment Limited Partnership. The biotech’s founding investors Catalys Pacific and DaVita Venture Group — which launched Pathalys in 2022 with ex-Asia rights to upacicalcet from EA Pharma — also backed the financing. Upacicalcet is a calcimimetic intended to help patients with secondary hyperparathyroidism (SHPT) control their intact parathyroid hormone levels (iPTH). Delivered intravenously at the end of a haemodialysis session, the candidate is designed to offer a better tolerability profile than currently available calcimimetic agents.Pathalys is running two identical, 27-week, double-blind, placebo-controlled Phase III studies to support approval of upacicalcet for patients with SHPT due to end-stage kidney disease (ESKD). According to ClinicalTrials.gov, the trials are expected to wrap next July.Upacicalcet is approved in Japan as Upasita based on data demonstrating the drug’s ability to reduce iPTH and maintain long-term iPTH suppression with fewer adverse events than currently available therapies.