Bio-Path Holdings Launches Development of Therapeutic Program for Obesity Treatment

Bio-Path Holdings Initiates New Therapeutic Program for Obesity Treatment

Bio-Path Holdings, Inc., a biotechnology firm known for its unique DNAbilize® liposomal delivery and antisense technology aimed at developing targeted nucleic acid cancer treatments, has announced the launch of a therapeutic program to develop BP1001-A for obesity and related metabolic diseases. This initiative represents the first application of DNAbilize technology outside of cancer treatments, showcasing the technology’s wider therapeutic potential.

The company has also reported successful enrollment in the third dosing cohort of its Phase 1/1b clinical trial evaluating BP1002 for patients with refractory/relapsed acute myeloid leukemia (AML), including those resistant to venetoclax. The enrollment phase was completed more quickly than anticipated, reflecting the pressing need for new treatment options for these patients.

Peter H. Nielsen, President and CEO of Bio-Path, expressed enthusiasm about the new focus on obesity treatment, emphasizing the significant public health challenge posed by the condition. He stated that the development of BP1001-A, which targets insulin resistance—a major factor contributing to obesity and Type 2 diabetes—has a high likelihood of success. The company plans to initiate Investigational New Drug (IND)-enabling testing of BP1001-A in the fourth quarter of 2024.

Nielsen also noted the swift completion of enrollment for the third dosing cohort of BP1002 in the clinical trial for AML patients. He highlighted that patients who have relapsed from initial venetoclax treatment and are resistant to further therapies often face severe survival challenges. He is hopeful that BP1002 may provide a viable treatment solution for these individuals.

BP1001-A for Obesity Treatment
The biological mechanisms behind obesity suggest that BP1001-A, which inhibits the adaptor protein Grb2, could effectively address insulin resistance—a key contributor to obesity and its associated metabolic disorders. Bio-Path anticipates that reducing Grb2 expression through BP1001-A will enhance insulin sensitivity. Preclinical studies to confirm these hypotheses are expected to commence in the fourth quarter of 2024. These investigations will provide essential insights into how BP1001-A may improve insulin sensitivity and its potential as a therapy for obesity and Type 2 diabetes, with hopes of following successful outcomes with a Phase 1 clinical trial.

Enrollment Completion for BP1002 in AML Patients
After the FDA’s review of data from the initial two dosing cohorts in the Phase 1/1b clinical trial for refractory/relapsed AML patients, Bio-Path moved forward with enrollment for the third, higher-dosing cohort at 60 mg/m2. The enrollment was concluded within six weeks, significantly faster than expected. This highlights the ongoing demand for innovative treatment options in AML. BP1002 aims to target the crucial protein associated with venetoclax treatment at the mRNA level, potentially overcoming resistance mechanisms that hinder the effectiveness of existing therapies.