Pathalys raises $105M to advance kidney disease treatment

Pathalys Pharma has successfully secured $105 million in a series B funding to advance its kidney disease therapy. This influx of capital is aimed at supporting the submission of a new drug application (NDA) to the FDA and initiating pre-commercialization activities for their promising treatment. The financing round was led by TCGX and included significant contributions from JP Morgan Life Sciences Private Capital, Samsara BioCapital, Marshall Wace, KB Investment, and JPS Growth Investment Limited Partnership. Additionally, Pathalys' founding investors, Catalys Pacific and DaVita Venture Group, who initially helped launch the company in 2022, also participated in the funding.

The primary focus of this financial boost is upacicalcet, a calcimimetic designed to aid patients suffering from secondary hyperparathyroidism (SHPT) in managing their intact parathyroid hormone (iPTH) levels. This therapeutic candidate is administered intravenously at the conclusion of a haemodialysis session and is expected to offer a better tolerability profile compared to existing calcimimetic agents.

To support the approval of upacicalcet for patients with SHPT due to end-stage kidney disease (ESKD), Pathalys is conducting two pivotal Phase III trials. These trials are 27-week, double-blind, placebo-controlled studies designed to provide robust data on the drug's efficacy and safety. According to ClinicalTrials.gov, these studies are anticipated to conclude by next July.

Upacicalcet has already garnered approval in Japan under the name Upasita, thanks to data showcasing its effectiveness in reducing iPTH levels and maintaining long-term suppression of iPTH with fewer adverse events compared to currently available treatments. This existing approval adds a layer of credibility and optimism for its potential success in other markets, including the United States.

The development of upacicalcet underscores Pathalys Pharma's commitment to addressing the unmet needs of patients with SHPT and ESKD, providing them with a potentially more tolerable and effective therapeutic option. The company’s strategic decision to secure substantial funding reflects its readiness to not only bring this promising treatment to market but also to lay the groundwork for its commercial success.

In summary, Pathalys Pharma's recent series B funding marks a significant milestone in the company's journey to advance its kidney disease therapy. With strong backing from prominent investors and a clear plan to move forward with regulatory submissions and pre-commercial activities, Pathalys is well-positioned to make a meaningful impact in the treatment of SHPT and ESKD. The ongoing Phase III trials and existing approval of upacicalcet in Japan further bolster the company's prospects, setting the stage for potential future successes in the global healthcare market.