Agios Pharmaceuticals, Inc. (AGIO - Free Report) , announced the initiation of the phase III ACTIVATE study which will evaluateits lead rare genetic diseases candidate, AG-348 in patients with Pyruvate kinase (PK) deficiency who do not receive regular blood transfusions. The ACTIVATE study will enroll about 80 adult patients with PK deficiency who do not receive regular blood transfusions. The ACTIVATE study aims to demonstrate that treatment with AG-348 leads to a sustained increase in hemoglobin in these patients.
AG-348 is also undergoing a phase III study called ACTIVATE-T, a single-arm pivotal study for in adult PK deficiency patients who receive regular blood transfusions.
Pyruvate kinase deficiency is a genetic blood disorder characterized by low levels of an enzyme called pyruvate kinase, which is used by red blood cells. Without pyruvate kinase, red blood cells break down too easily, resulting in low levels of these cells (hemolytic anemia)The ACTIVATE study aims to demonstrate that treatment with AG-348 leads to a sustained increase in hemoglobin in these patients.
The ACTIVATE study is divided into two parts. The primary endpoint of the study is the proportion of patients who achieve at least a 1.5 g/dL increase in hemoglobin sustained over multiple visits in Part 2 of the study.
In December last year, Agios reported impressive data from a phase II study on adult, transfusion-independent patients with PK deficiency. Data from the study demonstrated the candidate’s potential as the first disease-modifying therapy for patients with PK deficiency.
Shares of the company rose 2% following announcement of the news. Year to date, shares ofAgios have increased 66.6% compared with the industry’s gain of 9.2%.
Other than AG 348, Agios also has several interesting candidates in its pipeline. Its lead cancer pipeline includes Tibsovo which is under the priority review in the United States, the most advanced candidate targeting mutated isocitrate dehydrogenase 1 (IDH1). In December 2017, Agios submitted a new drug application (NDA) to the FDA for Tibsovo, which has been developed for treating patients with relapsed/refractory acute myeloid leukemia(R/R AML) and an IDH1 mutation.
Its other candidates include AG-881, which targets both mutated IDH1 and mutated IDH2. These mutations are found in a wide range of hematological malignancies and solid tumors including AML, chondrosarcoma and cholangiocarcinoma, where both the treatment options and prognosis for patients are poor.
Another candidate, AG-270, a first-in-class methionine adenosyltransferase 2a (MAT2A) inhibitor, is being evaluated in a phase I dose-escalation study in patients with methylthioadenosine phosphorylase (MTAP)-deleted tumors.
Zacks Rank & Stocks to Consider
Agios has a Zacks Rank #3 (Hold).
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