eClinical Technology and Industy News

Inozyme Pharma Announces First Self-Administration of INZ-701 in Ongoing ENPP1 Deficiency Phase 1/2 Clinical Trial

Excerpt from the Press Release:

BOSTON, Nov. 03, 2022 (GLOBE NEWSWIRE) — Inozyme Pharma, Inc. (Nasdaq: INZY), a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of pathologic mineralization and intimal proliferation, today announced the first self-administration of INZ-701 in the open-label Phase 2 extension portion of the ongoing Phase 1/2 clinical trial of INZ-701 in adult patients with ENPP1 Deficiency.

The implementation of self-administration of INZ-701 followed Inozyme’s submission of a protocol amendment to the U.S. Food and Drug Administration (FDA) and approval of a protocol amendment submitted to the German Federal Institute for Drugs and Medical Devices (BfArM). The Company has also submitted documentation to additional ex-U.S. regulatory agencies to allow self-administration. These submissions were supported by preliminary safety data from the ongoing trial.

“This is a significant milestone for a product candidate at this stage of its clinical and regulatory pathway and we believe highlights the safety profile of INZ-701 to date in our ongoing Phase 1/2 clinical trial,” said Kurt Gunter, M.D., Inozyme’s senior vice president and chief medical officer. “Self-administration opens up a convenient dosing option for patients in the Phase 2 extension. The extension portion of the trial is designed to provide important long-term safety and clinical data and support the development of INZ-701 as the first potential approved therapy for ENPP1 Deficiency.”

Click the button below to read the entire Press Release:

Continue Reading The Press Release

Discover What Sets TrialStat Apart From Ordinary EDC Platforms

Click the image or button below to explore our eClinical Suite Platform and discover what sets TrialStat apart from competing EDC platforms.

Request Your Demo Today!

From rapid database build through database lock, we deliver consistent quality on-time and on-budget. Ready to upgrade your eClinical toolkit?

Archives