Alnylam Reports Complete 18-month Data From Phase II OLE Study Of Patisiran

(RTTNews) - Alnylam Pharmaceuticals Inc. (ALNY), reported complete 18-month data from its ongoing Phase 2 open-label extension or OLE study with patisiran, an investigational RNAi therapeutic targeting transthyretin or TTR, for the treatment of hereditary ATTR amyloidosis with polyneuropathy (hATTR-PN), also known as familial amyloidotic polyneuropathy (FAP).

The company is presenting the new clinical data in an oral talk at the 68th Annual Meeting of the American Academy of Neurology being held April 15 to 21, 2016 in Vancouver, British Columbia, Canada.

The company noted that complete 18-month data from the study provide continued evidence that patisiran has the potential to halt neuropathy progression in patients with hATTR-PN.

Eric Green, Vice President, General Manager, TTR Program said, "We are pleased to see continued evidence for potential halting of neuropathy progression after 18 months of treatment in the ongoing Phase 2 OLE study with patisiran. The mean 0.8-point decrease in mNIS+7 is an encouraging finding, as the change in mNIS+7 from baseline to 18 months is the primary endpoint in our ongoing APOLLO Phase 3 trial with patisiran."

In the first reported exploratory analysis of its kind, the degree of TTR knockdown observed in patients was shown to correlate with improvement in neuropathy impairment scores. Further, in this Phase 2 OLE trial, patisiran was found to be generally well tolerated with up to 25 months of treatment.

The company is continuing dosing in the patisiran Phase 2 OLE study, and plans to report initial 24-month data from the trial in mid-2016.