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PHYOX Clinical Trial Engagement Website | Dicerna Pharmaceuticals

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PHYOXTM Clinical
Trial Program

Dicerna’s lead GalXCTM product candidate, nedosiran, formerly known as DCR-PHXC, is in clinical development for the treatment of known forms of primary hyperoxaluria (PH) – PH1, PH2, and PH3. The PHYOX7, PHYOX8, and PHYOX-OBX trials are now enrolling patients. Please find further details on these studies below.

Participating in a Trial

Physicians at leading research institutions who specialize in the treatment of PH are conducting the PHYOXTM clinical trials.

If you or a loved one has been diagnosed with PH and would like to participate in a clinical trial, please submit your information through the forms on the appropriate study pages. Please note, depending on a person’s eligibility to participate in the clinical trial, travel expenses to a clinical trial site will be covered by Dicerna.

Enrolling Studies

for participants with PH1 or PH2 and severe renal impairment, with or without dialysis (NCT04580420)

for PH patients aged 0-11 years with relatively intact renal function (NCT05001269)

for participants with PH3 who have a history of stone events (NCT04542590) – Observational study

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Studies Closed to Recruitment:

for participants with PH1 or PH2 (NCT03847909)

ENROLLMENT CLOSED

Dicerna’s pivotal trial was designed to evaluate the efficacy and safety of nedosiran delivered as a once-monthly subcutaneous injection in participants aged six years and older who have PH1 or PH2. Enrollment of 35 participants was completed in December 2020 and included participants across 11 countries, including the U.S., Japan and Europe

for participants who complete PHYOXTM trials (NCT04042402)

INVITATION ONLY

Dicerna’s ongoing open-label four-year extension study for participants who have completed another PHYOXTM study (except PHYOX7)


Siblings of participants in this trial may be enrolled directly into PHYOX3, if eligible

for participants with PH3
(NCT04555486)

ENROLLMENT CLOSED

Dicerna’s PHYOX4 trial was designed as a single-dose open-label study in participants aged six years and older diagnosed with PH3

For more information about the PHYOXTM clinical trial program or to find participating clinical trial sites, please contact Dicerna at medicalinfo@dicerna.com or go to https://www.clinicaltrials.gov/ and search for the respective NCT identifier number listed above.

Residents of the European Union can use EudraCT, a database of ongoing clinical trials in the EU, to access more information about the PHYOXTM trials.

Enrolling Studies:

PHYOX7 2020-002826-97

PHYOX8 2021-001083-16

Closed Recruitment Studies:

PHYOX2 2018-003098-91

PHYOX3 2018-003099-10

PHYOX4 2020-000344-67

About Primary Hyperoxaluria

Primary hyperoxaluria (PH) is a family of severe, ultra-rare, genetic liver disorders characterized by the overproduction of oxalate, a natural chemical in the body that is normally eliminated as waste through the kidneys. For more information on PH, click here.

About Dicerna

Dicerna Pharmaceuticals, Inc., a Novo Nordisk company, is focused on discovering, developing and commercializing medicines that are designed to leverage ribonucleic acid interference (RNAi) to silence selectively genes that cause or contribute to disease. Between Dicerna and our collaborative partners, we currently have more than 20 active discovery, preclinical or clinical programs focused on cardiometabolic, viral, chronic liver and complement-mediated diseases, as well as neurodegenerative diseases and pain.

For more information on Dicerna’s Privacy Policy, click here.

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Safety Information

Nedosiran, formerly DCR-PHXC, is an investigational drug intended for the treatment of patients with PH. Investigational drugs are medicines that have not yet been approved by appropriate regulatory agencies. The safety and efficacy for nedosiran has not been established yet. Current and future studies are evaluating the safety and efficacy for nedosiran.

©2021 Dicerna Pharmaceuticals, Inc. / Lexington, MA

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