Agios Initiates Trial on AG-348 - Analyst Blog

Agios Pharmaceuticals, Inc. AGIO announced the initiation of a multiple ascending dose (MAD) phase I trial on pipeline candidate AG-348.

The trial is being conducted among healthy volunteers to characterize the safety, tolerability, pharmacokinetics and pharmacodynamics of increasing doses of AG-348 for 14 days.

Agios is evaluating AG-348 for the treatment of pyruvate kinase (PK) deficiency.

Agios initiated the trial based on encouraging data from the ongoing single ascending dose (SAD) phase I trial wherein it was observed that AG-348 was well tolerated to date.

Agios started the SAD trial in Apr 2014 and has completed dosing of more than half of the planned cohorts. The company expects data from both the studies in 2015.

We note that AG-348 is currently the only candidate in Agios' pipeline which is being evaluated for the potential of correcting metabolic defects found in patients with PK deficiency.

Agios, a biopharmaceutical company, focuses on the treatment of patients suffering from cancer and inborn errors of metabolism (IEM).

The lead candidates in the cancer pipeline include - AG-221 and AG-120, which target mutant isocitrate dehydrogenase 2 and 1 while the lead candidate in the IEM program is AG-348.

Agios has a collaboration agreement with Celgene Corporation CELG with a focus on cancer metabolism. The discovery phase of the collaboration was due to expire in Apr 2014. However, in Dec 2013, Celgene extended the discovery phase for an additional year through Apr 2015.

Agios Pharma currently carries a Zacks Rank #3 (Hold). Right now, stocks like Gilead Sciences GILD and Alexion Pharmaceuticals ALXN look attractive.

While Gilead Sciences carry a Zacks Rank #1 (Strong Buy), Alexion Pharma is a Rank #2 (Buy).


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