Bio-Path Holdings Announces Preclinical Testing of BP1001-A as Potential Treatment for Obesity in Type 2 Diabetes Patients Enhances Insulin Sensitivity
Bio-Path Holdings (NASDAQ:BPTH) reported positive preclinical study results for BP1001-A as a potential treatment for obesity in Type 2 diabetes patients. The studies demonstrated that BP1001-A enhances insulin sensitivity by downregulating Grb2 protein expression, which helps lower blood glucose levels.
Key findings showed that BP1001-A reduced Grb2 protein expression in myoblast cells and increased phosphorylated AKT and FOXO-1 levels in myoblast and hepatoma cells with insulin present. The company has initiated animal studies and plans to begin a first-in-human Phase 1 clinical trial in 2025 to validate safety, measure pharmacokinetics, and establish dosing for potential pivotal trials.
Bio-Path Holdings (NASDAQ:BPTH) ha riportato risultati positivi da uno studio preclinico per BP1001-A come potenziale trattamento per l'obesità nei pazienti con diabete di Tipo 2. Gli studi hanno dimostrato che BP1001-A migliora la sensibilità all'insulina riducendo l'espressione della proteina Grb2, contribuendo così ad abbassare i livelli di glucosio nel sangue.
I risultati chiave hanno mostrato che BP1001-A ha ridotto l'espressione della proteina Grb2 nelle cellule mioblastiche e ha aumentato i livelli di AKT fosforilato e FOXO-1 nelle cellule mioblastiche e nei cellule di epatoma in presenza di insulina. L'azienda ha avviato studi su animali e prevede di iniziare un primo studio clinico di Fase 1 nell'uomo nel 2025 per convalidare la sicurezza, misurare la farmacocinetica e stabilire il dosaggio per potenziali studi pivotali.
Bio-Path Holdings (NASDAQ:BPTH) informó resultados positivos de un estudio preclínico para BP1001-A como un potencial tratamiento para la obesidad en pacientes con diabetes tipo 2. Los estudios demostraron que BP1001-A mejora la sensibilidad a la insulina al downregular la expresión de la proteína Grb2, lo que ayuda a reducir los niveles de glucosa en sangre.
Los hallazgos clave mostraron que BP1001-A redujo la expresión de la proteína Grb2 en células mioblásticas y aumentó los niveles de AKT fosforilado y FOXO-1 en células mioblásticas y en hepatomas en presencia de insulina. La compañía ha iniciado estudios en animales y planea comenzar un ensayo clínico de fase 1 en humanos en 2025 para validar la seguridad, medir la farmacocinética y establecer la dosificación para ensayos pivotales potenciales.
Bio-Path Holdings (NASDAQ:BPTH)는 제2형 당뇨병 환자에 대한 비만 치료제로서 BP1001-A의 긍정적인 전임상 연구 결과를 보고했습니다. 연구는 BP1001-A가 Grb2 단백질의 발현을 하향 조절함으로써 인슐린 감수성을 높이고, 혈당 수치를 낮추는 데 도움을 준다는 것을 보여주었습니다.
핵심 발견은 BP1001-A가 미오블라스트 세포에서 Grb2 단백질 발현을 줄이고, 인슐린이 존재하는 미오블라스트 및 간세포에서 인산화된 AKT와 FOXO-1의 수치를 증가시켰다는 것입니다. 회사는 동물 연구를 시작했으며, 2025년에는 안전성을 검증하고 약물동태를 측정하며 잠재적인 주요 시험을 위한 용량을 설정하기 위해 첫 번째 인체 임상 시험인 1상 연구를 시작할 계획입니다.
Bio-Path Holdings (NASDAQ:BPTH) a rapporté des résultats précliniques positifs pour BP1001-A en tant que traitement potentiel de l'obésité chez les patients diabétiques de type 2. Les études ont démontré que BP1001-A améliore la sensibilité à l'insuline en réduisant l'expression de la protéine Grb2, ce qui aide à abaisser les niveaux de glucose dans le sang.
Les résultats clés ont montré que BP1001-A a réduit l'expression de la protéine Grb2 dans les cellules myoblastes et a augmenté les niveaux d'AKT phosphorylé et de FOXO-1 dans les cellules myoblastes et les hépatomes en présence d'insuline. L'entreprise a initié des études animales et prévoit de commencer un essai clinique de Phase 1 chez l'homme en 2025 pour valider la sécurité, mesurer la pharmacocinétique et établir le dosage pour d'éventuels essais pivots.
Bio-Path Holdings (NASDAQ:BPTH) berichtete von positiven Ergebnissen aus einer präklinischen Studie zu BP1001-A als potenzieller Behandlung von Fettleibigkeit bei Patienten mit Typ-2-Diabetes. Die Studien zeigten, dass BP1001-A die Insulinempfindlichkeit verbessert, indem es die Expression des Grb2-Proteins herabreguliert, was hilft, die Blutzuckerspiegel zu senken.
Wichtige Erkenntnisse zeigten, dass BP1001-A die Grb2-Proteinausdrücke in Myoblastenzellen verringerte und die phosphorylierte AKT- und FOXO-1-Spiegel in Myoblasten- und Hepatomzellen in Anwesenheit von Insulin erhöhte. Das Unternehmen hat Tierstudien begonnen und plant, 2025 eine erste Phase-1-Studie am Menschen zu starten, um die Sicherheit zu validieren, die Pharmakokinetik zu messen und die Dosierung für potenzielle pivotalen Studien festzulegen.
- Successful preclinical testing demonstrated BP1001-A's effectiveness in enhancing insulin sensitivity
- Confirmed mechanism of action through reduction of Grb2 protein expression
- Addresses market gap where leading weight loss medications fail for Type 2 diabetes patients
- Phase 1 clinical trial planned for 2025
- Early-stage development with no human trial data yet
- Several years away from potential commercialization
- Will require significant additional clinical trials and regulatory approvals
Insights
This preclinical development for BP1001-A represents a potentially significant pivot into the lucrative obesity/diabetes market. The mechanism targeting Grb2 to enhance insulin sensitivity offers a novel approach distinct from GLP-1 agonists like Ozempic. Key preclinical data showing increased phosphorylated AKT and FOXO-1 levels validates the mechanistic hypothesis, though much validation work remains ahead.
The market opportunity is substantial - current GLP-1 drugs have efficacy in Type 2 diabetes patients with obesity. However, investors should note this is very early-stage research. The planned Phase 1 trial in 2025 puts any potential commercialization years away and success in animal studies doesn't guarantee human efficacy. For a micro-cap biotech with
The molecular pathway being targeted here is intriguing from a scientific perspective. By downregulating Grb2, which acts as a molecular switch in insulin signaling, BP1001-A could potentially enhance insulin sensitivity through the PI3K/AKT pathway - a well-established metabolic regulatory mechanism. The preclinical results showing increased phosphorylation of key downstream effectors AKT and FOXO-1 provide encouraging proof-of-concept.
In simpler terms, this drug candidate appears to help cells respond better to insulin by removing a protein that interferes with insulin's effects. This could help diabetic patients control their blood sugar more effectively. However, the jump from cell studies to animal studies and eventually human trials is significant, with many potential obstacles ahead.
Preclinical Studies Confirmed BP1001-A Mechanism of Action and Therapeutic Potential in Obesity and Type 2 Diabetes
HOUSTON, Dec. 19, 2024 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, today reported that results from preclinical studies of BP1001-A for obesity demonstrated enhanced insulin sensitivity, confirming BP1001-A as a potential treatment for obesity and related metabolic diseases in Type 2 diabetes patients.
BP1001-A downregulates growth factor receptor-bound protein 2 (Grb2) expression to increase insulin sensitivity and helps lower blood glucose level in Type 2 diabetes patients. Scientific evidence suggests that by downregulating Grb2 expression, BP1001-A could help lower blood glucose level by affecting insulin signaling. Bio-Path conducted preclinical studies that confirmed the effectiveness of BP1001-A in affecting insulin signaling and its potential efficacy as a therapeutic treatment for obese patients who have Type 2 diabetes. The study results showed:
- BP1001-A reduced Grb2 protein expression in myoblast cells
- BP1001-A increased the levels of phosphorylated AKT and phosphorylated FOXO-1 in myoblast and hepatoma cells in the presence of insulin
These initial data confirmed that by downregulating Grb2 expression, BP1001-A could enhance insulin-induced metabolic events by affecting the insulin/phosphoinositol-3 kinase (PI3K)/AKT pathway and increase insulin sensitivity.
“The success of our initial preclinical testing, which supports the mechanism of action and highlights the efficacy of BP1001-A to enhance insulin sensitivity, further validates BP1001-A as a potential treatment for obesity in Type 2 diabetes patients. The failure of leading weight loss medications to induce weight loss in obese patients who have Type 2 diabetes creates a compelling need for an alternative method of lowering blood glucose in obese patients who have Type 2 diabetes,” said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. “We are excited by the rapid progress we have made advancing BP1001-A as a potential treatment for obesity and related metabolic diseases in Type 2 diabetes patients based on previous BP1001-A preclinical studies as they support our continued and rapid development of this promising program.”
Bio-Path has initiated animal studies to confirm the efficacy of BP1001-A as a potential treatment for obesity and related metabolic diseases in Type 2 diabetes patients. If successful, Bio-Path anticipates initiating a first-in-human Phase 1 clinical trial in 2025 to further validate safety, measure pharmacokinetics and establish dosing for potential pivotal trials.
About Bio-Path Holdings, Inc.
Bio-Path is a biotechnology company developing DNAbilize®, a novel technology that has yielded a pipeline of RNAi nanoparticle drugs that can be administered with a simple intravenous infusion. Bio-Path’s lead product candidate, prexigebersen (BP1001, targeting the Grb2 protein), is in a Phase 2 study for blood cancers, and BP1001-A, a drug product modification of prexigebersen, is in a Phase 1/1b study for solid tumors. The Company’s second product, BP1002, which targets the Bcl-2 protein, is being evaluated for the treatment of blood cancers and solid tumors, including acute myeloid leukemia. In addition, an IND application is expected to be filed for BP1003, a novel liposome-incorporated STAT3 antisense oligodeoxynucleotide developed by Bio-Path as a specific inhibitor of STAT3.
For more information, please visit the Company's website at http://www.biopathholdings.com.
Forward-Looking Statements
This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws. These statements are based on management's current expectations and accordingly are subject to uncertainty and changes in circumstances. Any express or implied statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Any statements that are not historical facts contained in this release are forward-looking statements that involve risks and uncertainties, including Bio-Path’s ability to raise needed additional capital on a timely basis in order for it to continue its operations, have success in the clinical development of its technologies, the timing of enrollment and release of data in such clinical studies, the accuracy of such data, limited patient populations of early stage clinical studies and the possibility that results from later stage clinical trials with much larger patient populations may not be consistent with earlier stage clinical trials, the maintenance of intellectual property rights, that patents relating to existing or future patent applications will be issued or that any issued patents will provide meaningful protection of our drug candidates, the impact, risks and uncertainties related to global pandemics, including the COVID-19 pandemic, and actions taken by governmental authorities or others in connection therewith, and such other risks which are identified in Bio-Path's most recent Annual Report on Form 10-K, in any subsequent quarterly reports on Form 10-Q and in other reports that Bio-Path files with the Securities and Exchange Commission from time to time. These documents are available on request from Bio-Path Holdings or at www.sec.gov. Bio-Path disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Contact Information:
Investors
Will O’Connor
Stern Investor Relations, Inc.
212-362-1200
will@sternir.com
Doug Morris
Investor Relations
Bio-Path Holdings, Inc.
832-742-1369
FAQ
What are the key findings of BPTH's BP1001-A preclinical studies for obesity treatment?
When will BPTH begin human clinical trials for BP1001-A in obesity treatment?
How does BPTH's BP1001-A work to treat obesity in Type 2 diabetes patients?
What advantage does BPTH's BP1001-A offer over existing weight loss medications?
