The Phase 1b clinical trial can accelerate HQP1351’s clinical development program globally

Ascentage Pharma, a biotechnology company that is involved in the development of novel therapies for hepatitis B virus, age-related diseases and cancers, recently announced that the Food & Drug Administration (FDA) has cleared an Investigational New drug (IND) application that enables the company to initiate a Phase 1b clinical trial of HQP1351 in the U.S.

For the record, HQP1351 is a drug candidate that Ascentage Pharma has developed to treat patients with tyrosine kinase inhibitors (TKI)- resistant chronic myeloid leukemia (CML).

Apparently, HQP1351 happens to be Ascentage’s sixth molecule that received IND clearance from FDA. The company had reportedly submitted data to FDA which was generated from more than 100 subjects in Phase 1 trial in China in order to support the applications for IND.

According to reports, the clinical study is Phase Ib clinical trial that gives three dose cohorts that is more efficient compared to the traditional 3+3 dose-escalation study and could accelerate the clinical trial’s progress. The trial is designed to evaluate tolerability, pharmacokinetic and safety of HQP1351 in patients who are suffering from CML and are intolerant and resistant to the second-line TKIs, as well as to confirm the Phase II dose (RP2D) as recommended.

Seemingly, at the 60^th American Society of Hematology (ASH) Annual Meeting, data from HQP1351 Phase 1 study in China had been accepted as an oral presentation last December. HQP13351 had been effective while treating the first and the second generation TKI-resistant CML, more importantly the highly resistant CML with T3151 mutations, along with enhanced safety profile in comparison with the other agents in the same class.

The results demonstrated best-in-class potential of HQP1351 for the treatment of TKI-resistant CML.

Ascentage Pharma’s Chief Medical Officer, Dr. Yifan Zhai stated that the Phase 1b clinical trial can accelerate HQP1351’s clinical development program significantly. The company hopes for HQP1351 to meet patients’ unmet clinical need worldwide.

Source Credits-

https://www.prnewswire.com/news-releases/ascentage-pharma-to-initiate-phase-ib-study-of-hqp1351-in-tyrosine-kinase-inhibitors--resistant-chronic-myeloid-leukemia-patients-in-the-us-300888373.html