Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) announced the presentation of results from the Company’s Phase 1A study in healthy volunteers evaluating oral non-covalent reversible BTK inhibitor SNS-062. The results were presented in a poster session titled “CLL: Therapy, excluding Transplantation: Poster I” on Saturday, December 3, at the 58th American Society of Hematology Annual Meeting in San Diego, California.
“These final results from the Phase 1A Healthy Volunteer study suggest that SNS-062, with a favorable safety, pharmacokinetic (PK) and pharmacodynamic (PD) profile, and its improved PK properties over ibrutinib and acalabrutinib, has significant potential to become a new treatment option for patients with B-cell malignancies,” said Linda Neuman, M.D., Vice President, Clinical Development of Sunesis. “Additionally, as a non-covalent BTK inhibitor with a distinct reversible binding profile, SNS-062 may overcome the acquired resistance to ibrutinib and other covalent clinical-stage BTK inhibitors resulting from a point mutation (C481S) in the active site.”
“The safety profile, extent of SNS-062 exposure, and duration of BTK inhibition from these study results are encouraging and support our plans for a Phase 1B/2 study to assess safety and efficacy in patients with advanced B-cell malignancies after prior ibrutinib exposure, both with and without a BTK C481 mutation,” said Daniel Swisher, President and Chief Executive Officer of Sunesis. “We are preparing an IND filing for this year as we work closely with our identified clinical sites for this study, and expect to begin dosing patients within the first half of 2017.”
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 25, 50, 100, 200, and 300 mg (n=6 per cohort) or placebo (n=2 per cohort).
For the primary endpoint of safety in stage 1, 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. In the unblinded stages 2 and 3 of the trial, a similar pattern and rate of AEs were observed. Overall, 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 6.9 to 17 hours. SNS-062 demonstrated rapid, profound (~100%), and prolonged inhibition of BTK at all dose levels support investigation of a twice-daily dosing regimen in B-cell malignancies with or without an acquired BTK resistance mutation.
Furthermore in stage 2, food had no impact on the extent of absorption or elimination of SNS-062, suggesting that it may be administered to patients without regard to food. In stage 3, SNS-062, similar to ibrutinib, is a sensitive substrate of CYP3A4 and administration with moderate/strong CYP3A4 inhibitors or inducers is not recommended. (Original Source)
Shares of Sunesis Pharmaceuticals are currently trading at $3.98, up $0.08 or 1.95%. SNSS has a 1-year high of $6.30 and a 1-year low of $2.63. The stock’s 50-day moving average is $4.08 and its 200-day moving average is $3.85.
On the ratings front, SNSS stock has been the subject of a number of recent research reports. In a report issued on November 3, Cowen analyst Eric Schmidt reiterated a Hold rating on SNSS. Separately, on the same day, Cantor’s Mara Goldstein reiterated a Buy rating on the stock .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Eric Schmidt and Mara Goldstein have a yearly average return of 21.2% and 1.4% respectively. Schmidt has a success rate of 53% and is ranked #55 out of 4240 analysts, while Goldstein has a success rate of 42% and is ranked #1505.
Sunesis Pharmaceuticals, Inc. operates as a biopharmaceutical company. It engages in development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers. Its efforts are currently focused primarily on the development of vosaroxin for the treatment of acute myeloid leukemia. The company’s primary activities include conducting research and development internally and through corporate collaborators, in-licensing and out-licensing pharmaceutical compounds and technology, conducting clinical trials and raising capital.