SOUTH SAN FRANCISCO, CA, USA I September 12, 2016 I Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced results from the Company’s Phase 1A study in healthy volunteers evaluating oral non-covalent BTK inhibitor SNS-062. The study demonstrated a favorable safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile for SNS-062 in healthy subjects. The results were presented on Saturday, September 10th at the European School of Haematology’s (ESH) 2nd International Conference on New Concepts in B-Cell Malignancies at the Estoril Congress Centre in Estoril, Portugal.
“Our first-in-human clinical results are encouraging and reinforce our belief that SNS-062 has the potential to become an important new treatment option for patients with B-cell malignancies,” said Linda Neuman, M.D., Vice President, Clinical Development of Sunesis. “Notably, SNS-062 exposure, even at the lowest dose of 50 mg, exceeded those reported for both ibrutinib and acalabrutinib at their respective recommended dose levels, suggesting that SNS-062 has improved PK properties. Furthermore, as a non-covalent BTK inhibitor with a distinct binding profile, SNS-062 may overcome the acquired resistance to ibrutinib and other covalent clinical-stage inhibitors resulting from a point mutation (C481S) in the BTK active site.”
“The safety profile and the extent and duration of BTK inhibition by SNS-062 support the timely advancement of this program into cancer-directed studies,” said Daniel Swisher, President and Chief Executive Officer of Sunesis. “We look forward to moving SNS-062 into a planned Phase 1B/2 study of patients with advanced B-cell malignancies.”
The reported data from this Phase 1A randomized, double-blind, placebo-controlled, single-dose study are from four sequential cohorts of 8 subjects each who were randomly assigned to receive progressively higher single oral administrations of SNS-062 at doses of 50, 100, 200, and 300 mg (n=6 per cohort) or placebo (n=2 per cohort). An evaluation of the effects of food and CYP3A4 inhibition on the PK of SNS-062 is ongoing.
For the primary endpoint of safety, investigators were blinded to treatment arm for assessment of relatedness. Overall, AEs were reported for 8 (33%) subjects who received SNS-062 and for 3 (38%) subjects who received placebo. Treatment-related AEs were reported in 6/24 (25%) subjects who received SNS-062 compared with 3/8 (38%) subjects who received placebo. For patients who received SNS-062, treatment-related AEs included headache, nausea, and supraventricular tachycardia. In the placebo group, treatment-related AEs included headache, nausea, and diarrhea. No obvious pattern of dose-dependent toxicity was observed. All AEs were transient and low grade. None of the AEs, laboratory abnormalities, or ECG or telemetry findings were considered clinically meaningful. No SAEs were reported.
SNS-062 was rapidly absorbed and had mean plasma half-life values across all dose cohorts of 7.4 to 17 hours. SNS-062 concentrations declined in a multiphasic manner. Total exposure (AUC and Cmax) increased proportionally with dose. SNS-062 demonstrated rapid, profound (~100%), and prolonged inhibition of BTK at all dose levels supporting a future twice-daily dosing regimen.
The poster, titled “A Phase 1A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of the Noncovalent Bruton Tyrosine Kinase (BTK) Inhibitor SNS-062 in Healthy Subjects: Preliminary Results” is available on the Sunesis website at www.sunesis.com.
Conference Call and Webcast Information
Sunesis will host a conference call and slide webcast today, Monday, September 12 at 8:00 a.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international), and entering passcode 70718677. To access the live audio webcast, or the subsequent archived recording, visit the “Investors and Media – Calendar of Events” section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.
About SNS-062
SNS-062 is a novel, second-generation BTK inhibitor, a class of kinase inhibitors that selectively inhibits the enzyme Bruton’s tyrosine kinase (BTK). This target mediates signaling through the B-cell receptor, which is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. SNS-062’s favorable safety, pharmacokinetics, potency, kinase selectivity and non-covalent binding profile support the advancement to a Phase 1B/2 study in patients with B-cell malignancies. This study will include patients with an acquired resistance from a C481S mutation at the point in the enzyme’s binding site required for covalent binding of ibrutinib and other covalent inhibitors.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to improving the lives of people with cancer. Currently, the company is focused on pursuing regulatory approval in Europe for its lead product candidate, vosaroxin, for the treatment of relapsed or refractory acute myeloid leukemia in patients aged 60 and older, as well as advancing its novel kinase-inhibitor pipeline, which includes its proprietary non-covalent BTK-inhibitor, SNS-062. For additional information on Sunesis, please visit http://www.sunesis.com.
SOURCE: Sunesis Pharmaceuticals
Post Views: 89
SOUTH SAN FRANCISCO, CA, USA I September 12, 2016 I Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced results from the Company’s Phase 1A study in healthy volunteers evaluating oral non-covalent BTK inhibitor SNS-062. The study demonstrated a favorable safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile for SNS-062 in healthy subjects. The results were presented on Saturday, September 10th at the European School of Haematology’s (ESH) 2nd International Conference on New Concepts in B-Cell Malignancies at the Estoril Congress Centre in Estoril, Portugal.
“Our first-in-human clinical results are encouraging and reinforce our belief that SNS-062 has the potential to become an important new treatment option for patients with B-cell malignancies,” said Linda Neuman, M.D., Vice President, Clinical Development of Sunesis. “Notably, SNS-062 exposure, even at the lowest dose of 50 mg, exceeded those reported for both ibrutinib and acalabrutinib at their respective recommended dose levels, suggesting that SNS-062 has improved PK properties. Furthermore, as a non-covalent BTK inhibitor with a distinct binding profile, SNS-062 may overcome the acquired resistance to ibrutinib and other covalent clinical-stage inhibitors resulting from a point mutation (C481S) in the BTK active site.”
“The safety profile and the extent and duration of BTK inhibition by SNS-062 support the timely advancement of this program into cancer-directed studies,” said Daniel Swisher, President and Chief Executive Officer of Sunesis. “We look forward to moving SNS-062 into a planned Phase 1B/2 study of patients with advanced B-cell malignancies.”
The reported data from this Phase 1A randomized, double-blind, placebo-controlled, single-dose study are from four sequential cohorts of 8 subjects each who were randomly assigned to receive progressively higher single oral administrations of SNS-062 at doses of 50, 100, 200, and 300 mg (n=6 per cohort) or placebo (n=2 per cohort). An evaluation of the effects of food and CYP3A4 inhibition on the PK of SNS-062 is ongoing.
For the primary endpoint of safety, investigators were blinded to treatment arm for assessment of relatedness. Overall, AEs were reported for 8 (33%) subjects who received SNS-062 and for 3 (38%) subjects who received placebo. Treatment-related AEs were reported in 6/24 (25%) subjects who received SNS-062 compared with 3/8 (38%) subjects who received placebo. For patients who received SNS-062, treatment-related AEs included headache, nausea, and supraventricular tachycardia. In the placebo group, treatment-related AEs included headache, nausea, and diarrhea. No obvious pattern of dose-dependent toxicity was observed. All AEs were transient and low grade. None of the AEs, laboratory abnormalities, or ECG or telemetry findings were considered clinically meaningful. No SAEs were reported.
SNS-062 was rapidly absorbed and had mean plasma half-life values across all dose cohorts of 7.4 to 17 hours. SNS-062 concentrations declined in a multiphasic manner. Total exposure (AUC and Cmax) increased proportionally with dose. SNS-062 demonstrated rapid, profound (~100%), and prolonged inhibition of BTK at all dose levels supporting a future twice-daily dosing regimen.
The poster, titled “A Phase 1A Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of the Noncovalent Bruton Tyrosine Kinase (BTK) Inhibitor SNS-062 in Healthy Subjects: Preliminary Results” is available on the Sunesis website at www.sunesis.com.
Conference Call and Webcast Information
Sunesis will host a conference call and slide webcast today, Monday, September 12 at 8:00 a.m. Eastern Time. The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international), and entering passcode 70718677. To access the live audio webcast, or the subsequent archived recording, visit the “Investors and Media – Calendar of Events” section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.
About SNS-062
SNS-062 is a novel, second-generation BTK inhibitor, a class of kinase inhibitors that selectively inhibits the enzyme Bruton’s tyrosine kinase (BTK). This target mediates signaling through the B-cell receptor, which is critical for adhesion, migration, proliferation and survival of normal and malignant B-lineage lymphoid cells. SNS-062’s favorable safety, pharmacokinetics, potency, kinase selectivity and non-covalent binding profile support the advancement to a Phase 1B/2 study in patients with B-cell malignancies. This study will include patients with an acquired resistance from a C481S mutation at the point in the enzyme’s binding site required for covalent binding of ibrutinib and other covalent inhibitors.
About Sunesis Pharmaceuticals
Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the potential treatment of solid and hematologic cancers. Sunesis has built a highly experienced cancer drug development organization committed to improving the lives of people with cancer. Currently, the company is focused on pursuing regulatory approval in Europe for its lead product candidate, vosaroxin, for the treatment of relapsed or refractory acute myeloid leukemia in patients aged 60 and older, as well as advancing its novel kinase-inhibitor pipeline, which includes its proprietary non-covalent BTK-inhibitor, SNS-062. For additional information on Sunesis, please visit http://www.sunesis.com.
SOURCE: Sunesis Pharmaceuticals
Post Views: 89
