Pathalys Pharma, Inc. Launches with Mission to Address High Priority Needs in Chronic Kidney Disease

RESEARCH TRIANGLE PARK, N.C., March 1, 2022 /PRNewswire/ -- Pathalys Pharma, Inc., a private, late-stage biopharma company committed to the development and commercialization of a range of best-in-class therapies for patients with chronic kidney disease (CKD), today announced its formation made possible through initial seed financing from DaVita Venture Group, part of DaVita Inc. (NYSE: DVA), and Catalys Pacific. Pathalys launches with a novel clinical-stage asset, upacicalcet, that was acquired through a license granted by EA Pharma for exclusive rights to the development and commercialization of the product, worldwide outside of Japan and Asia.  

"We are excited about this opportunity to join forces with DaVita, a recognized leader in kidney care, in an effort to advance multiple best-in-class therapies for patients with CKD who are in need of better treatments – beginning with upacicalcet," said BT Slingsby, M.D., Ph.D., M.P.H., founder and Executive Chairman of Pathalys and Managing Partner, Catalys Pacific.

Upacicalcet is an intravenously administered investigational small molecule calcimimetic that may control intact parathyroid hormone (iPTH) levels in patients with secondary hyperparathyroidism (SHPT) receiving hemodialysis (HD). Upacicalcet was granted Marketing Authorization in Japan in 2021, under the brand name UPASITA®, based on a phase 3, 24-week double-blind, placebo-controlled dose-titration study and a second phase 3, 52-week open-label, dose-titration study. In these studies, upacicalcet was shown to significantly reduce iPTH and maintain long-term iPTH suppression, as well as demonstrate the potential for fewer adverse events (AEs) than currently available therapies.

In anticipation of a submission to the U.S. Food and Drug Administration (FDA), Pathalys intends to conduct two identical phase 3 clinical trials designed as randomized, double-blind, placebo-controlled studies with 27-week individualized dose titration periods in patients with SHPT due to end-stage kidney disease (ESKD) on maintenance HD.

"DaVita's support of Pathalys Pharma underscores our commitment to bringing to market innovations that may help improve the health and quality of life of kidney care patients," said Mahesh Krishnan, M.D., M.PH., M.B.A., F.A.S.N., Pathalys director, and Group Vice President of Research and Development at DaVita. "By combining the unique development strengths of Catalys Pacific with DaVita's kidney care expertise, we believe Pathalys can be a platform for delivering a range of novel products and solutions that help improve patient lives."

Chief Executive Officer and Board Appointments
Joining BT Slingsby and Mahesh Krishnan on the Pathalys Board of Directors are Jay Shepard, Pathalys co-founder and Venture Partner at Catalys Pacific; and Takeshi Takahashi, M.B.A., Pathalys co-founder and Managing Partner at Catalys Pacific.

Additionally, Neal Fowler, a seasoned industry veteran and former Chief Executive Officer (CEO) at Liquidia Corporation (NASDAQ: LQDA) has been appointed CEO at Pathalys and will serve on the company's board of directors.

BT Slingsby continued, "We are very pleased to welcome Neal to Pathalys as CEO and member of the Pathalys Board of Directors. Neal is a proven business leader with significant experience and success in the biopharmaceutical industry and at all stages of a company's life cycle. We are delighted to have a leader of his caliber and unwavering commitment to success lead this new venture."

While at Liquidia, Mr. Fowler also co-founded and served as CEO of Envisia Therapeutics (acquired), an ophthalmology therapeutics company. Prior to Liquidia, Neal worked for seven years with Johnson & Johnson (NYSE: JNJ), serving as President of Centocor, Inc., a global multi-billion-dollar subsidiary focused on biomedicines, and President of Ortho-McNeil Neurologics, a company focused on neurological disorders. Mr. Fowler started his career with Eli Lilly and Company, working for 13 years in a variety of sales, marketing, and business development roles in both the pharmaceutical and medical device divisions. Mr. Fowler is the current chair of both NCBIO and the UNC Eshelman School of Pharmacy Foundation. He is a native of Raleigh, North Carolina and earned his B.S. degree in Pharmacy and M.B.A., both from the University of North Carolina at Chapel Hill.

"I am honored to have the opportunity to lead Pathalys, a company formed by industry leaders with a passion to improve the lives of patients living with CKD. I am very optimistic about the future of our organization and our lead asset, upacicalcet, as well as the other opportunities that exist to expand our portfolio," said Mr. Fowler. "I look forward to announcing additional members of our Executive Team soon and to working with them and members of the Pathalys Board of Directors to bring meaningful change to the lives of CKD patients and value to our stakeholders."

About Pathalys Pharma, Inc.
Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of advanced therapeutics that address unmet needs in the management of ESKD. Pathalys' initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT. Beyond upacicalcet, Pathalys continues to identify other high priority needs and potential solutions for patients with ESKD. Pathalys is headquartered in Research Triangle Park, North Carolina. For more information about Pathalys, please visit www.pathalys.com.

About Catalys Pacific
Catalys Pacific is an independent venture capital firm focusing on early-stage investments in life sciences. The firm's mission is to focus on providing healthcare solutions for patients worldwide through the creation of and investment in biotech companies. Catalys Pacific is led by a global team versed in working closely with its partners in academia, biotech, venture capital and the pharmaceutical industry in Japan and worldwide. The firm maintains offices in Tokyo and Kanagawa (Shonan Health Innovation Park), Japan and in San Francisco, California. For more information about Catalys Pacific, please visit www.catalyspacific.com.

About DaVita
DaVita (NYSE: DVA) is a comprehensive kidney care provider focused on transforming care to improve the quality of life for patients globally. The company is one of the largest providers of kidney care services in the U.S. and has been a leader in clinical quality and innovation for more than 20 years. DaVita is working to help increase equitable access to care for patients at every stage and setting along their kidney health journey—from slowing progression of kidney disease to streamlining the transplant process, from acute hospital care to dialysis at home. As of December 31, 2021, DaVita served 203,000 patients at 2,815 outpatient dialysis centers in the U.S. The company operated an additional 339 outpatient dialysis centers in ten countries worldwide. DaVita has reduced hospitalizations, improved mortality and worked collaboratively to propel the kidney care community to adopt an equitable, high-quality standard of care for all patients, everywhere. To learn more, visit DaVita.com/About .

About EA Pharma Co., Ltd.
EA Pharma Co., Ltd., a subsidiary of Eisai Co., Ltd., was established in April 2016 by integration of the gastrointestinal business unit with more than 60 year's history of the Eisai Group and the gastrointestinal business unit of the Ajinomoto Group having amino acid as its business core. EA Pharma Co., Ltd., is a gastrointestinal specialty pharmaceutical company with a full value chain covering R&D, production & logistics and sales & marketing.

For further information on EA Pharma Co., Ltd., please visit www.eapharma.co.jp/en.

DaVita Inc. Forward-Looking Statements
Certain statements in this press release are forward-looking statements that are subject to risks and uncertainties. These forward-looking statements are based on management's current expectations. Various important factors could cause actual results to differ materially from these forward-looking statements, including the risks identified in our U.S. Securities and Exchange Commission filings. DaVita disclaims any obligation to update any forward-looking statement contained in this press release, except as may be otherwise required by law.

SOURCE Pathalys Pharma