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Alnylam initiates Phase II study of ALN-TTR02

Alnylam Pharmaceuticals has begun Phase II trial and completed enrolment in Phase I trial and of ALN-TTR02, an RNAi therapeutic targeting transthyretin (TTR) for the treatment of TTR-mediated amyloidosis (ATTR).

The Phase II trial will evaluate the clinical activity, safety and tolerability of multiple once-monthly doses of ALN-TTR02 in ATTR patients.

Alnylam anticipates presenting data from the Phase I trial early in the third quarter of 2012.

Alnylam senior vice president and chief medical officer Akshay Vaishnaw said with dosing completed in the Phase I study, the company is on track to report results early in the third quarter.

"Our Phase II study is now underway, and will evaluate a once-monthly multi-dose regimen in ATTR patients," Vaishnaw added.

"We look forward to continuing to share clinical data from our ALN-TTR02 program, and, assuming positive results in the current Phase II study, we plan to advance to a pivotal trial in 2013."

The subjects will be enrolled into cohorts of increasing doses and will receive drug once every four weeks for two cycles in Phase II trial.

The clinical activity of ALN-TTR02 will be evaluated based on measurement of serum levels of TTR, the disease-causing protein in patients with ATTR.