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Regulus Weighs Dual Development Track for HCV Drug

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NEW YORK (GenomeWeb) — Buoyed by positive Phase I data on its microRNA-targeting hepatitis C drug RG-101, Regulus Therapeutics is aiming to begin Phase II testing of the drug in combination with an oral direct-acting antiviral (DAA) drug in the second quarter of next year, company officials said this week.

At the same time, the company is weighing a "dual-track" approach for the drug's development, which would pursue its use as part of a combination therapy with an approved DAA as a first-line treatment, as well as in patients who have failed other treatments, according to Regulus CMO Paul Grint.

"We’re considering options in both Europe and the United States and we’re aggressively planning for our next study," he said during a conference call held to discuss Regulus's third-quarter financial results.

While that Phase II trial is slated for the second quarter of 2015, "there is a potential to begin earlier in 2015, but this depends on the speed of our dialogues with regulatory authorities and input from key opinion leaders," he added.

During the call, Regulus President and CEO Kleanthis Xanthopoulos also noted that while the company is in discussions with potential partners for RG-101, it intends to conduct at least the upcoming Phase II trial independently.

Regulus had previously partnered with GlaxoSmithKline on RG-101 and certain other programs, but the big pharma later stepped away from the HCV candidate. More recently, GlaxoSmithKline dropped out of the alliance altogether after deciding that it did not fit within its overall research priorities.

Elsewhere in Regulus's pipeline, the Alport syndrome therapy RG-102 continues to make progress in preclinical development and is on track to enter Phase I testing in the first half of 2015, Regulus said. The company is also aiming to nominate a third clinical candidate in the second half of next year.

Q3

For the quarter ended Sept. 30, Regulus reported a net loss of $9.8 million, or $.23 a share, versus a year-ago loss of $2.2 million, or $.05 a share.

Revenues in the quarter were $1.1 million, down from $6.1 million the year before, primarily due to a large payment received from partner Sanofi in the third quarter 2013.

Research and development spending rose to $10.2 million from $7.1 million, while general and administrative costs climbed to $2.6 million from $1.9 million.

As of Sept. 30, Regulus had cash, cash equivalents, and short-term investments totaling $94.1 million. This figure does not include the impact of a $103.5 million stock offering completed this month, which Regulus expects will net it $76.1 million.

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