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TMCNet:  Acceleron Announces New Interim Phase 2 Data on Sotatercept and ACE-536 to be Reported at Three Oral Presentations at the 19th Annual Congress of the European Hematology Association

[May 21, 2014]

Acceleron Announces New Interim Phase 2 Data on Sotatercept and ACE-536 to be Reported at Three Oral Presentations at the 19th Annual Congress of the European Hematology Association

CAMBRIDGE, Mass. --(Business Wire)--

Acceleron Pharma Inc. (NASDAQ:XLRN), a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases, today reported that Acceleron, Celgene and investigators in the sotatercept and ACE-536 phase 2 clinical trials will give three oral presentations of interim data from ongoing studies in beta-thalassemia and myelodysplastic syndromes as well as a poster presentation of nonclinical data in sickle cell disease at the 19th Annual Congress of the European Hematology Association (EHA) in Milan, Italy from June 12-15, 2014.

ACE-536: Beta-thalassemia Oral Presentation




Data in abstract (S664)
  • Dose dependent hemoglobin increases at Day 63 of 0.0, 0.9 and 1.4 g/dL were observed across the first three cohorts of ACE-536 at doses of 0.2 mg/kg, 0.4 mg/kg and 0.6 mg/kg, respectively
  • Preliminary efficacy data were available for the four transfusion dependent (TD) patients (in 0.6 and 0.8 mg/kg groups) enrolled to date and demonstrated reductions in transfusion requirements
Additional data to be

presented at EHA

  • For the non-transfusion dependent (NTD) patients, hemoglobin data from the 0.8 mg/kg ACE-536 group will be presented as well as data for all patients at all four dose groups through Day 112
Date/Time/Location Saturday, June 14, at 8:45 AM (CEST) in room "Brown 3", Session "Red Cell Clinical"

ACE-536: Myelodysplastic Syndromes Oral Presentation

Data in abstract (S1296)
  • Preliminary efficacy data were available for 15 patients (5 NTD and 10 TD) treated in the first 4 cohorts (0.125, 0.25, 0.5, or 0.75 mg/kg ACE-536 cohorts)
    • The 5 NTD patients demonstrated dose-dependent increases in hemoglobin, with maximum hemoglobin increase ranging from 0.8 to 3.3 g/dL
      • 3 of the 5 NTD patients were in the 0.75 mg/kg group and were either erythropoietin-stimulating agent (ESA) refractory or ESA non-responders and had maximum hemoglobin increases of 1.6, 1.9, and 3.3 g/dL. One NTD patient in this 0.75 mg/kg group had a hemoglobin increase =1.5 g/dL sustained for ~15 weeks
    • Four of the 10 TD patients had a =50% reduction in units transfused during an 8-week interval on treatment compared to the 8 weeks prior to treatment, including 1 patient, previously ESA and lenalidomide non-responsive, who was transfusion-free while on study (~22 weeks)
Additional data to be

presented at EHA

  • For the TD patients, data on transfusion burden will also be presented for patients from the 1.0 mg/kg group
 
Date/Time/Location Sunday, June 15, at 8:45 AM (CEST) in "Auditorium", Session "Myelodysplastic Syndromes - Clinical"

Sotatercept: Beta-thalassemia Oral Presentation

Data in abstract (S662)
  • For the NTD patients, during the first 3 cycles (9 weeks)
    • Hemoglobin increases of =1.0 g/dL were seen in 0%, 83%, and 83% in the 0.1, 0.3, and 0.5 mg/kg sotatercept groups, respectively
    • Hemoglobin increases of =2.0 g/dL were seen in 0%, 17%, and 33% in the 0.1, 0.3, and 0.5 mg/kg sotatercept groups, respectively
Additional data to be

presented at EHA
EH

-- Data from the 0.75 mg/kg group will be presented for the first time at this meeting

 

  • For the TD patients, changes in transfusion burden will be presented for the 0.1, 0.3. 0.5 and 0.75 sotatercept mg/kg groups
  • For the NTD patients, hemoglobin data from 0.75 mg/kg group will also be presented
Date/Time/Location Saturday, June 14, at 8:15 AM (CEST) in room "Brown 3", Session "Red Cell Clinical"

ACE-536: Sickle Cell Disease Poster Presentation

Data in abstract (P535)
  • Following one month of treatment, RAP-536 (murine version of ACE-536) significantly increased red blood cell (RBC) number and hemoglobin compared to placebo treatment in sickle cell disease (SCD) mice
    • Importantly, the increased RBC occurred while reticulocytes decreased, which is potentially consistent with an increase in red cell half-life
  • RAP-536 treatment of SCD mice for 6-weeks resulted in a substantial decrease in phosphatidylserine (PS) exposure
Additional data to be

presented at EHA

  • Following treatment with RAP-536 for three months, the percent change in irreversibly sickled cells (SC) will also be presented
Date/Time/Location Friday, June 13, at 5:45 - 7:00 PM (CEST) in Poster Area, Session "Red Cell Biology"

About ACE-536

ACE-536 is a modified type IIB activin receptor fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-ß) superfamily involved in the late stages of erythropoiesis (red blood cell production). ACE-536 regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing ACE-536 as part of a global collaboration. ACE-536 is currently in phase 2 clinical trials in patients with beta-thalassemia and in patients with myelodysplastic syndromes. For more information, please visit www.clinicaltrials.gov.

About Sotatercept

Sotatercept is an activin receptor type IIA fusion protein that acts as a ligand trap for members in the Transforming Growth Factor-Beta (TGF-ß) superfamily involved in the late stages of erythropoiesis (red blood cell production). Sotatercept regulates late-stage erythrocyte (red blood cell) precursor cell differentiation and maturation. This mechanism of action is distinct from that of erythropoietin (EPO), which stimulates the proliferation of early-stage erythrocyte precursor cells. Acceleron and Celgene are jointly developing sotatercept as part of a global collaboration. Sotatercept is currently in multiple phase 2 clinical trials. For more information, please visit www.clinicaltrials.gov.

About Acceleron

Acceleron is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of novel protein therapeutics for cancer and rare diseases. The company is a leader in understanding the biology of the Transforming Growth Factor-Beta (TGF-ß) protein superfamily, a large and diverse group of molecules that are key regulators in the growth and repair of tissues throughout the human body, and in targeting these pathways to develop important new medicines. Acceleron has built a highly productive R&D platform that has generated innovative clinical and preclinical protein therapeutic candidates with novel mechanisms of action. These protein therapeutic candidates have the potential to significantly improve clinical outcomes for patients with cancer and rare diseases.

For more information, please visit www.acceleronpharma.com.

Cautionary Note on Forward-Looking Statements

This press release includes forward-looking statements about the Company's strategy, future plans and prospects, including statements regarding the development of the Company's compounds, including sotatercept and ACE-536, the expected timing for the reporting of data from ongoing trials, and the structure of the Company's planned or pending clinical trials. The words "anticipate," "appear," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that the preclinical testing of the Company's compounds and preliminary data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that data may not be available when we expect it to be, that the Company will be unable to successfully complete the clinical development of its compounds, that the development of the Company's compounds will take longer or cost more than planned, and that the Company's compounds will not receive regulatory approval or become commercially successful products. Other risks and uncertainties include those identified under the heading "Risk Factors" included in the Company's Form 10-K which was filed with the Securities and Exchange Commission (SEC (News - Alert)) on March 17, 2014, and other filings that the Company may make with the SEC in the future. The forward-looking statements contained in this press release reflect the Company's current views with respect to future events, and the Company does not undertake and specifically disclaims any obligation to update any forward-looking statements.


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