phase 1 clinical trial

Regulus Earns $10.0 Million Milestone Payment from AstraZeneca and Achieves Key Goal for 2015

regulus therapeutics logoLA JOLLA, Calif., Dec. 18, 2015 /PRNewswire/ — Regulus Therapeutics Inc. (NASDAQ: RGLS), a biopharmaceutical company leading the discovery and development of innovative medicines targeting microRNAs, announced today that dosing has begun in a first-in-human Phase I clinical study of RG-125(AZD4076), by its collaboration partner AstraZeneca. RG-125(AZD4076) is a GalNAc-conjugated anti-miR-103/107 oligonucleotide that has been shown to improve insulin sensitivity and glucose tolerance in animal models. RG-125(AZD4076) was jointly identified and selected as a clinical candidate in April 2015 by AstraZeneca under the companies’ strategic alliance to discover, develop and commercialize microRNA therapeutics. AstraZeneca will pay Regulus $10.0 million and will assume further development of RG-125(AZD4076).

Previous research has demonstrated a causative role of microRNAs in pathophysiological processes of metabolic diseases, and increased expression of miR-103/107 in the liver has been associated with insulin resistance in people with non-alcoholic steatopheatitis (NASH), or fatty liver disease.  In mechanistic studies, RG-125(AZD4076) showed effects on biological pathways implicated in NASH progression.

“RG-125(AZD4076) acts as a novel insulin sensitizer which represents a potential new mechanism to treat patients with metabolic diseases such as type 2 diabetes and NASH,” said Paul Grint, MD, President and Chief Executive Officer of Regulus. “Regulus is pleased to [click to continue…]

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miRagen Therapeutics LogoBOULDER, Colorado, – November 12, 2015 – miRagen Therapeutics, Inc. a biopharmaceutical company developing innovative microRNA-based therapeutics, today announced that it has initiated a Phase 1 clinical study of MRG-201, a synthetic microRNA mimic (promiR) to microRNA-29b.  The Phase 1 trial is being conducted in normal healthy volunteers and may be extended to patients suffering from cutaneous scleroderma.

“As a Company dedicated to improving human health through the discovery and development of innovative RNA-targeting therapies like MRG-201, we are excited by this event,” said William Marshall, Chief Executive Officer of miRagen.  “The initiation of this clinical trial advances a potentially important new therapy for patients suffering from pathological fibrosis and is an example of our focus on areas of high unmet medical need.”

“We are excited to move MRG-201, our lead anti-fibrosis product candidate, into this first-in-human safety, tolerability and dose-range finding trial,” added David Rodman [click to continue…]

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