Benzinga | Oct 15, 2021 04:04PM EDT

Dicerna Announces Data To Be Presented At American Society Of Nephrology (ASN) Kidney Week 2021

Dicerna Pharmaceuticals, Inc. (NASDAQ:DRNA), a leading developer of investigational ribonucleic acid interference (RNAi) therapeutics, today announced an abstract on clinical data from the Company's PHYOX(tm)2 trial of nedosiran, an investigational GalXC(tm) RNAi candidate for the treatment of primary hyperoxaluria (PH), has been accepted as a late-breaker poster presentation at the American Society of Nephrology (ASN) Kidney Week 2021 taking place Nov. 4-7, 2021.

"PHYOX2 generated robust data in patients with PH1, meeting the primary and key secondary efficacy endpoints, while also showing that nedosiran was safe and generally well tolerated in the trial," said Douglas Fambrough, Ph.D., President and Chief Executive Officer at Dicerna. "We are excited to share these results and believe that the selection of nedosiran data for a late-breaker presentation at ASN Kidney Week underscores the importance of providing the medical community with new information about potential therapy options for the treatment of patients with PH1. We continue to believe that these data support potential approval of nedosiran for the treatment of PH1 in the U.S., Europe, Japan and other markets, and we remain on track to submit an NDA to the FDA in the fourth quarter."

Dr. Fambrough continued, "We continue to work in consultation with scientific advisors, clinicians and the patient community to evaluate the outcomes observed in patients with PH type 2 (PH2). Given the significant unmet medical need, we believe further assessment of nedosiran's potential in treating PH2 is warranted. We are actively engaged in out-licensing discussions to commercialize nedosiran for patients with PH1 and have expanded these interactions to include the potential for continued research and clinical development in PH2."

The schedule for Dicerna's presentations is as follows:

Session: Late-Breaking Clinical Trial Posters

Poster Title: PHYOX(tm)2: Nedosiran Reduced Urinary Oxalate Excretion in Patients With Primary Hyperoxaluria

Poster #: PO2538

A poster summarizing an analysis of healthcare utilization and outcomes in patients with PH and an informational poster on additional trials in the PHYOX clinical development program will also be presented.

Session: Genetic Diseases of the Kidneys: Non-Cystic -- 1

Poster Title: Real-World Healthcare Utilization and Clinical Markers Preceding Dialysis in Patients with Primary Hyperoxaluria (PH) in the United States

Poster #: PO1317

Session: Informational Posters

Poster Title: The PHYOX(tm) Clinical Program for Primary Hyperoxaluria

Poster #: INFO22

All three posters will be available on the ASN website starting Thursday, Nov. 4 at 10:00 a.m. PDT/1:00 p.m. EDT.