Pathalys Pharma to Present at the 21st Annual Needham Virtual Healthcare Conference

Research Triangle Park, N.C., April 8, 2022 – 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 end stage kidney disease (ESKD), today announced that the company will participate in the 21st Annual Needham Virtual Healthcare Conference, taking place April 11-14, 2022.

Presentation Details:
Conference –
21st Annual Needham Virtual Healthcare Conference
Date / Time – Tuesday, April 12th, 11:00 AM ET

Presenter – Neal Fowler, Chief Executive Officer at Pathalys Pharma
Format: – Virtual presentation

Pathalys will also be participating in one-on-one investor meetings throughout the conference. Investors interested in scheduling a meeting with the Pathalys management team should contact their Needham representative.

 

About Pathalys Pharma, Inc.

Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple 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 in hemodialysis patients. 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.

 

Contact Information

Media Contact:
Michael Parks
484.356.7105

Investor Contact:
Patrick Treanor
ptreanor@pathalys.com

 

Pathalys Pharma Announces Phase 3 Program for Upacicalcet

– Plans for Phase 3 Program Presented at National Kidney Foundation’s Annual Spring Clinical Meeting –

Research Triangle Park, N.C., April 7, 2022 – 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 end stage kidney disease (ESKD), today announced plans for a phase 3 program to support the application of upacicalcet (designated PLS240 for clinical trials), globally. Pathalys holds exclusive rights for the development and commercialization of upacicalcet, a novel calcimimetic, worldwide outside of Japan and Asia.  

“This is a very exciting time for Pathalys as we set out to further understand the full clinical potential of upacicalcet in patients with ESKD through two phase 3 studies that will form the basis for our applications for approval,” said Dr. Theodore Danoff, Chief Medical Officer and SVP, Clinical Development at Pathalys. “Upacicalcet is a novel calcimimetic that performed exceptionally well in phase 3 studies in Japan where it was recently approved for the treatment of SHPT in patients on dialysis. We look forward to the opportunity to demonstrate its effectiveness for patients in the US and other markets globally.”

In a poster presented today at the National Kidney Foundation’s Annual Spring Clinical Meeting (SCM22), the company disclosed its plans to initiate two phase 3 clinical trials in 2022 to evaluate upacicalcet as a treatment alternative to currently available calcimimetics.

The two identically designed phase 3 clinical trials will assess the efficacy of upacicalcet in reducing intact parathyroid hormone (iPTH) by 30 percent or more in participants with secondary hyperparathyroidism (SHPT) and currently on hemodialysis.

Each trial will randomize approximately 375 patients (2:1) to upacicalcet or placebo. Eligible patients will be adults receiving in-center hemodialysis three times weekly and whose iPTH values are 450 pg/mL or greater. Upacicalcet will be titrated based on iPTH and serum corrected calcium (cCa) levels with dose steps between 25 and 300 µg as a bolus IV injection given at the end of a dialysis session. Upacicalcet starting dose will be 50 µg if cCa is 9.0 mg/dL or greater or 25 µg if cCa is below 9.0 mg/dL. Doses will be titrated to maintain iPTH in the range of 150-300 pg/mL.

 

Japanese Approval and Clinical Trial:

Upacicalcet was approved last year in Japan (under the brand name UPASITA®) based in part on a randomized, double-blind, placebo-controlled phase 3 study in hemodialysis patients with SHPT. The study evaluated upacicalcet when administered three times weekly with a starting dose of 25 or 50 μg IV based on cCa levels and was titrated from 25 to 300 μg over 24 weeks.

The primary endpoint was the proportion of patients with a mean iPTH between 60 and 240 pg/mL over weeks 22 to 24 and was achieved in 69 of 103 patients (67.0 percent) in the upacicalcet group and 4 of 50 patients (8.0 percent) in the placebo group (difference of 59.0 percent, p<0.001).

A 30 percent or greater reduction in mean iPTH over weeks 22 to 24 was achieved by 80.6 percent in the upacicalcet group compared to 8.0 percent in the placebo group (difference of 72.6 percent; p<0.001).

Upper gastrointestinal disorder adverse drug reactions (ADRs) were reported in two of 103 patients (1.9 percent) in the upacicalcet group and in three of 50 patients (6.0 percent) in the placebo group. The incidence of calcium less than 7.5 mg/dL was low with 2 events (1.9 percent).

 

About Pathalys Pharma, Inc.

Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple 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 in hemodialysis patients. 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.

 

Contact Information

Media Contact:
Michael Parks
484.356.7105

 

Investor Contact:

Patrick Treanor
ptreanor@pathalys.com

 

Pathalys Pharma Announces Executive Team Appointments

– Executive Leadership Team Brings Diverse Skills and Broad Expertise to New Venture –

RESEARCH TRIANGLE PARK, N.C., March 30, 2022 – 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 the executive leadership team for the newly formed company. Pathalys officially launched on March 1, 2022.


“It is my privilege to announce Pathalys’ executive team. This robust and highly capable team of leaders has extensive experience in building companies and a demonstrated track record of delivering results in their respective areas,” said Neal Fowler, Chief Executive Officer at Pathalys Pharma, Inc. “I am confident that this group of accomplished leaders, along with our distinguished board, can deliver on our mission to successfully advance upacicalcet and other enhanced therapeutics with the expressed goal of transforming the lives of CKD patients.”


The following individuals have joined the Pathalys Executive Team reporting to Mr. Fowler:

  • Dr. Ashwin Ram – Co-founder and Senior Vice President, Operations
  • Patrick Treanor – Chief Operating Officer
  • David Banks – Senior Vice President, Technical Operations
  • Dr. Theodore Danoff – Chief Medical Officer and Senior Vice President, Clinical Development
  • Greg Klatt – Vice President, Finance

 

Executive Leadership Team

Ashwin Ram, M.D., is a Pathalys co-founder and the Senior Vice President, Operations. Dr. Ram is a physician-scientist, biotechnology entrepreneur, and investor at Catalys Pacific. He is the founder and chair of Jupiter Therapeutics, Inc., and previously worked at Genentech in early clinical development. Dr. Ram is a board-certified radiation oncologist who completed his medical degree at the University of Michigan Medical School with Alpha Omega Alpha honors and residency training at The Johns Hopkins Hospital. He completed a graduate degree in bioengineering at Caltech and a postdoctoral fellowship at Stanford University as an NIH/NCI Cancer Translational Nanotechnology Fellow.

Patrick Treanor, M.B.A., is the Chief Operating Officer. Prior to his appointment, Mr. Treanor was President, U.S. for Vifor Pharma, an international pharmaceutical company focused on nephrology. Mr. Treanor started his career with large pharmaceutical organizations such as Johnson & Johnson (NYSE: JNJ) and Abbott Laboratories (NYSE: ABT) over 25 years ago but found his niche building early-stage commercial organizations at companies such as Oscient Pharmaceuticals, AMAG Pharmaceuticals and Relypsa. Mr. Treanor holds a B.S. in Management from Bryant University and an M.B.A. from Rensselaer Polytechnic Institute.

David Banks, M.B.A., is the Senior Vice President, Technical Operations. Mr. Banks has more than 30 years of manufacturing, supply chain, and quality experience in the pharmaceutical industry, having held positions of increasing responsibility at several companies, including GSK (NYSE: GSK), Roche (as Syntex), Johnson & Johnson (as Alza), and Gilead (NASDAQ: GILD). Mr. Banks earned a B.S. in Engineering from Tennessee Tech University, a M.B.A. from East Tennessee State University, and a M.S. in Finance from the University of San Francisco.

Theodore Danoff, M.D., Ph.D., is the Chief Medical Officer and Senior Vice President, Clinical Development. Dr. Danoff is a graduate of the Medical Scientist Training Program at the University of Chicago with a Ph.D. in Immunology. He completed his residency in internal medicine and fellowship in nephrology at the Hospital of the University of Pennsylvania and then served on the faculty as an Assistant Professor in the Renal Division in the Department of Medicine. He has worked in the pharmaceutical industry for more than 20 years at organizations, including GlaxoSmithKline (NYSE: GSK), Endo Pharmaceuticals (NASDAQ: ENDP), Clarus Therapeutics (NASDAQ: CRTX), and Complexa Inc. He has co-authored more than 40 peer-reviewed publications, five book chapters, and has two issued patents.

Greg Klatt, C.P.A., is the Vice President, Finance. Previously, Mr. Klatt was Assistant Controller at Aravive, Inc. (NASDAQ: ARAV), a clinical-stage biopharmaceutical company developing treatments designed to halt the progression of life-threatening diseases, including cancer and fibrosis. Before Aravive, he held positions at Alvarez & Marsal, as well as Ernst & Young. Mr. Klatt earned his B.S. at the University of Oregon and holds his license as a C.P.A. in the State of California.

 

About Pathalys Pharma, Inc.

Pathalys Pharma, Inc. is a private, late-stage clinical biopharmaceutical company committed to the development of multiple advanced therapeutics that address unmet needs in the management of end stage kidney disease (ESKD). Pathalys’ initial asset is upacicalcet, a novel calcimimetic with the potential to improve the treatment of SHPT in hemodialysis patients. 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.

Contact Information

Media Contact:
Michael Parks
484.356.7105

Investor Contact:
Patrick Treanor
ptreanor@pathalys.com