Bio-Path Holdings Starts Obesity Treatment Program

Bio-Path Holdings, Inc. (NASDAQ: BPTH), a biotechnology firm using its DNAbilize® liposomal delivery and antisense technology, is branching out into new therapeutic areas. The company announced the development of BP1001-A for the treatment of obesity and related metabolic diseases. This move represents the first utilization of DNAbilize technology beyond oncology, demonstrating the technology's broad applicability.

Bio-Path also reported completing the enrollment for the third dosing cohort in its ongoing Phase 1/1b clinical trial of BP1002, aimed at treating refractory or relapsed acute myeloid leukemia (AML) patients, including those resistant to venetoclax. The swift enrollment underscores the critical need for new treatment options for these patients.

Peter H. Nielsen, the President and CEO of Bio-Path, described the new program as an exciting opportunity to address the growing obesity epidemic. BP1001-A's mechanism of action aims to treat insulin resistance, a key factor in obesity, Type 2 diabetes, and other metabolic disorders. Bio-Path plans to begin Investigational New Drug (IND)-enabling tests for BP1001-A in the fourth quarter of 2024.

BP1001-A is designed to suppress the adaptor protein Grb2, which is implicated in insulin resistance. By downregulating Grb2, BP1001-A hopes to enhance insulin sensitivity, tackling a fundamental cause of obesity and Type 2 diabetes. Preclinical studies slated for late 2024 will aim to validate these assumptions and provide insights into BP1001-A's mechanism and effectiveness. If successful, these studies could pave the way for a Phase 1 clinical trial.

In parallel, Bio-Path reported rapid progress in the Phase 1/1b clinical trial of BP1002, targeting patients with refractory or relapsed AML. Following the U.S. Food and Drug Administration's (FDA) review of data from the first two dosing cohorts, enrollment for the third, higher-dosing cohort was completed ahead of schedule. This rapid enrollment reflects the urgent need for alternative treatments for AML patients who have relapsed from front-line venetoclax-based therapies and are unresponsive to salvage therapy. BP1002 targets the key protein involved in venetoclax treatment at the mRNA level, potentially overcoming some of the resistance mechanisms associated with venetoclax.

Bio-Path Holdings, Inc. is advancing its DNAbilize® technology, which has generated a pipeline of RNAi nanoparticle drugs administered via simple intravenous infusion. The company’s lead product candidate, prexigebersen (BP1001), targets the Grb2 protein and is currently in a Phase 2 study for blood cancers. BP1001-A, a modified version of prexigebersen, is in a Phase 1/1b study for solid tumors. Another product, BP1002, targets the Bcl-2 protein and is being tested for blood cancers and solid tumors, including lymphoma and AML.

Additionally, Bio-Path plans to file an IND application for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide, intended as a specific inhibitor of STAT3. This move further expands the company's therapeutic portfolio, emphasizing its commitment to addressing various unmet medical needs through innovative RNAi-based treatments.