Sunesis Pharmaceuticals, Inc. (NASDAQ:SNSS) recently announced that it will not conduct a Phase 2 clinical trial of its vecabrutinib contrary to previously announced plans.
The biopharma revealed that its vecabrutinib Program will not be advancing to the earlier planned Phase 2 stage expected to follow the Phase 1b/2 clinical trial. The latter aimed to investigate vecabrutinib’s effectiveness in treating patients suffering from relapsed chronic lymphocytic leukemia (CLL). The company decided unfavorable findings from the phase 1b/2 clinical study in which some of the patients were treated with up to 500 mg of vecabrutinib.
“Although vecabrutinib continues to exhibit an excellent safety profile, there is insufficient evidence of activity in BTK-inhibitor-resistant B-cell malignancies to advance the drug into the planned Phase 2 portion of the trial,” stated Sunesis CEO, Dayton Misfeldt.
The CEO also pointed out that there was only 1 partial remission in a CLL patient after 11 treatment cycles. Numerous patients in different dosage cohorts continued to demonstrate disease stability, which means that the results were not conclusive enough to support the advancement of the drug trials.
Despite the lack of favorable findings from the early clinical study, Misfeldt stated that the company will continue running the Phase 1b clinical trial until the end. This will help Sunesis to determine the best possible direction for the future of vecabrutinib. The CEO also expressed gratitude to the patients that were part of the clinical study, as well as their families.
Sunesis will shift its focus to SNS-510
Sunesis also revealed that after its decision to discontinue the vecabrutinib program, it will divert its development focus and resources to SNS-510. The latter is the company’s flagship PDK1 inhibitor designed to inhibit PIP3-independent and PI3K-dependent pathways that facilitate the development of hematologic and solid malignancies.
Sunesis claims that it is still on track with the SNS-510 development, and it hopes to file for an IND before the end of 2020. The company also plans to present the findings involving the PDK1 inhibitor at a medical conference within H2, 2020. The CEO also stated that Sunesis has enough cash resources to fund its activities well into 2021.