Bio-Path Holdings Announces Pre-Clinical Results Signaling Increased Potential for BP1001-A as Treatment for Obesity in Type 2 Diabetes Patients
Bio-Path Holdings (BPTH) has announced promising pre-clinical results for BP1001-A as a potential treatment for obesity in Type 2 diabetes patients. The studies demonstrated that BP1001-A successfully attenuated fatty acid-induced insulin resistance and restored insulin sensitivity in muscle progenitor and skeletal muscle fiber cell models.
The drug works by downregulating growth factor receptor-bound protein 2 (Grb2) expression to increase insulin sensitivity and help lower blood glucose levels. Recent testing confirmed BP1001-A's effectiveness in both myoblast cells and C2C12 myotubes, particularly in counteracting the insulin resistance caused by palmitic acid, a common saturated fatty acid in high-fat diets.
Bio-Path plans to conduct final pre-clinical testing using a mouse model in the first half of 2025 to assess BP1001-A's impact on animal weight, insulin sensitivity, and glucose tolerance. Upon successful completion, the company aims to file an Investigational New Drug (IND) application in 2025 to initiate a first-in-human Phase 1 clinical trial.
Bio-Path Holdings (BPTH) ha annunciato risultati preclinici promettenti per BP1001-A come potenziale trattamento per l'obesità nei pazienti con diabete di tipo 2. Gli studi hanno dimostrato che BP1001-A ha attenuato con successo la resistenza all'insulina indotta dagli acidi grassi e ha ripristinato la sensibilità all'insulina nei modelli cellulari di progenitori muscolari e fibre muscolari scheletriche.
Il farmaco agisce riducendo l'espressione della proteina legata al recettore del fattore di crescita 2 (Grb2) per aumentare la sensibilità all'insulina e aiutare a ridurre i livelli di glucosio nel sangue. Test recenti hanno confermato l'efficacia di BP1001-A sia nelle cellule mioblastiche che nei miotubi C2C12, in particolare nel contrastare la resistenza all'insulina causata dall'acido palmitico, un comune acido grasso saturo nelle diete ad alto contenuto di grassi.
Bio-Path prevede di condurre test preclinici finali utilizzando un modello murino nella prima metà del 2025 per valutare l'impatto di BP1001-A sul peso animale, sulla sensibilità all'insulina e sulla tolleranza al glucosio. Al termine di una riuscita fase di test, l'azienda intende presentare una domanda di Nuovo Farmaco Sperimentale (IND) nel 2025 per avviare un trial clinico di fase 1 per la prima volta sull'uomo.
Bio-Path Holdings (BPTH) ha anunciado resultados preclínicos prometedores para BP1001-A como un posible tratamiento para la obesidad en pacientes con diabetes tipo 2. Los estudios demostraron que BP1001-A atenuó con éxito la resistencia a la insulina inducida por ácidos grasos y restauró la sensibilidad a la insulina en modelos celulares de progenitores musculares y fibras musculares esqueléticas.
El fármaco actúa al regular a la baja la expresión de la proteína unida al receptor del factor de crecimiento 2 (Grb2) para aumentar la sensibilidad a la insulina y ayudar a reducir los niveles de glucosa en sangre. Pruebas recientes confirmaron la efectividad de BP1001-A tanto en células mioblásticas como en miotubos C2C12, especialmente en contrarrestar la resistencia a la insulina causada por el ácido palmítico, un ácido graso saturado común en dietas altas en grasas.
Bio-Path planea realizar pruebas preclínicas finales utilizando un modelo de ratón en la primera mitad de 2025 para evaluar el impacto de BP1001-A en el peso animal, la sensibilidad a la insulina y la tolerancia a la glucosa. Tras la finalización exitosa, la empresa tiene como objetivo presentar una solicitud de Nuevo Medicamento en Investigación (IND) en 2025 para iniciar un ensayo clínico de fase 1 en humanos por primera vez.
Bio-Path Holdings (BPTH)는 제2형 당뇨병 환자의 비만 치료를 위한 잠재적 치료제로서 BP1001-A의 유망한 전임상 결과를 발표했습니다. 연구 결과 BP1001-A가 지방산 유도 인슐린 저항성을 성공적으로 완화하고 근육 전구체 및 골격근 섬유 세포 모델에서 인슐린 민감성을 회복시켰음을 보여주었습니다.
이 약물은 성장 인자 수용체 결합 단백질 2(Grb2) 발현을 하향 조절하여 인슐린 민감성을 증가시키고 혈당 수치를 낮추는 데 도움을 줍니다. 최근 테스트에서는 BP1001-A가 미오블라스트 세포와 C2C12 미오튜브 모두에서 효과적임을 확인했으며, 특히 고지방 식단에서 흔히 발견되는 포화 지방산인 팔미트산으로 인한 인슐린 저항성을 상쇄하는 데 효과적이었습니다.
Bio-Path는 2025년 상반기에 쥐 모델을 사용하여 BP1001-A의 동물 체중, 인슐린 민감성 및 포도당 내성에 미치는 영향을 평가하기 위한 최종 전임상 테스트를 수행할 계획입니다. 성공적으로 완료되면, 회사는 2025년에 임상 1상 시험을 시작하기 위해 임상 연구용 신약(IND) 신청서를 제출할 예정입니다.
Bio-Path Holdings (BPTH) a annoncé des résultats précliniques prometteurs pour BP1001-A en tant que traitement potentiel de l'obésité chez les patients atteints de diabète de type 2. Les études ont démontré que BP1001-A atténuait avec succès la résistance à l'insuline induite par les acides gras et restaurait la sensibilité à l'insuline dans des modèles cellulaires de progéniteurs musculaires et de fibres musculaires squelettiques.
Le médicament agit en régulant à la baisse l'expression de la protéine liée au récepteur du facteur de croissance 2 (Grb2) afin d'augmenter la sensibilité à l'insuline et d'aider à réduire les niveaux de glucose dans le sang. Des tests récents ont confirmé l'efficacité de BP1001-A tant dans les cellules myoblastiques que dans les myotubes C2C12, notamment pour contrer la résistance à l'insuline causée par l'acide palmitique, un acide gras saturé courant dans les régimes riches en graisses.
Bio-Path prévoit de réaliser des tests précliniques finaux en utilisant un modèle murin dans la première moitié de 2025 pour évaluer l'impact de BP1001-A sur le poids animal, la sensibilité à l'insuline et la tolérance au glucose. Après une réussite, l'entreprise vise à déposer une demande de médicament expérimental (IND) en 2025 pour initier un essai clinique de phase 1 chez l'homme.
Bio-Path Holdings (BPTH) hat vielversprechende präklinische Ergebnisse für BP1001-A als potenzielle Behandlung von Fettleibigkeit bei Patienten mit Typ-2-Diabetes bekannt gegeben. Die Studien zeigten, dass BP1001-A erfolgreich die durch Fettsäuren induzierte Insulinresistenz abschwächte und die Insulinempfindlichkeit in Modellen von Muskelvorläufer- und Skelettmuskelzellen wiederherstellte.
Das Medikament wirkt, indem es die Expression des wachstumsfaktorbindenden Proteins 2 (Grb2) herunterreguliert, um die Insulinempfindlichkeit zu erhöhen und die Blutzuckerwerte zu senken. Jüngste Tests bestätigten die Wirksamkeit von BP1001-A sowohl in Myoblastenzellen als auch in C2C12-Miotuben, insbesondere bei der Bekämpfung der durch Palmitinsäure, einer häufigen gesättigten Fettsäure in fettreichen Diäten, verursachten Insulinresistenz.
Bio-Path plant, in der ersten Hälfte von 2025 abschließende präklinische Tests mit einem Mausmodell durchzuführen, um die Auswirkungen von BP1001-A auf das Tiergewicht, die Insulinempfindlichkeit und die Glukosetoleranz zu bewerten. Nach erfolgreichem Abschluss beabsichtigt das Unternehmen, im Jahr 2025 einen Antrag auf einen neuen Prüfmedikament (IND) zu stellen, um eine erste klinische Studie der Phase 1 am Menschen zu initiieren.
- Successful pre-clinical results showing BP1001-A's effectiveness in restoring insulin sensitivity
- Clear pathway to IND filing in 2025 for first-in-human trials
- Novel mechanism of action addressing unmet medical need in obesity treatment
- Still in early pre-clinical stage with no human trial data
- Final mouse model studies yet to be completed
- Success in cell models may not translate to effective treatment in humans
Insights
Bio-Path's pre-clinical results for BP1001-A represent a promising scientific development in the metabolic disease space. The data showing BP1001-A's ability to attenuate fatty acid-induced insulin resistance and restore insulin sensitivity in muscle cell models demonstrates a clear mechanism of action that could potentially address a significant unmet medical need.
The research effectively establishes proof-of-concept in two important cellular models: muscle progenitor cells (myoblasts) and skeletal muscle fiber cells (myotubes). This dual validation strengthens the scientific foundation by confirming effects in both developing and mature muscle tissues. The specific focus on countering palmitic acid-induced insulin resistance is particularly relevant, as this saturated fatty acid is prevalent in high-fat diets and a known contributor to metabolic dysfunction.
From a development perspective, Bio-Path is following a logical progression through pre-clinical testing, with the final mouse model studies representing the critical transition from in vitro to in vivo validation. The planned analysis of animal weight, insulin sensitivity, and glucose tolerance will determine whether BP1001-A's cellular effects translate to meaningful physiological improvements in a complete organism. This step is essential before advancing to human studies.
The company's DNAbilize® liposomal delivery system, which enables targeted antisense therapy, provides a differentiated technological approach to addressing insulin resistance compared to existing treatment modalities. By targeting Grb2 expression through antisense technology, Bio-Path is pursuing a novel mechanism that could potentially complement or provide an alternative to current diabetes treatments.
Bio-Path's expansion of BP1001-A into the obesity/diabetes space represents a strategic pipeline diversification that could significantly broaden the company's market potential. This application leverages their existing antisense technology platform into a high-value therapeutic area where there remains substantial unmet need despite recent advances in treatment options.
The company has identified a specific market gap - obese patients with Type 2 diabetes who don't respond well to existing medications - positioning BP1001-A as a potential solution for this treatment-resistant population. This targeted approach could create a valuable niche, even in an increasingly competitive metabolic disease landscape.
From a development timeline perspective, the company's projection to complete pre-clinical studies and file an IND in 2025 suggests reasonable progress for this program. While still early-stage, the defined pathway from current cell models to mouse studies to IND filing demonstrates structured development planning.
What's particularly notable is Bio-Path's efficient use of their existing technology. BP1001-A is already in Phase 1/1b testing for solid tumors, so the company benefits from existing safety data and manufacturing processes. This dual-purpose development strategy maximizes return on their R&D investment in the underlying DNAbilize® platform and the specific BP1001-A compound.
For a company with a modest market capitalization of approximately
Recent Pre-Clinical Studies Showed BP1001-A Attenuated Fatty Acid-Induced Insulin Resistance and Restored Insulin Sensitivity in Muscle Progenitor and Skeletal Muscle Fiber Cell Models
HOUSTON, March 18, 2025 (GLOBE NEWSWIRE) -- Bio-Path Holdings, Inc., (OTCQB:BPTH), a biotechnology company leveraging its proprietary DNAbilize® liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, today reported results from recent preclinical studies of BP1001-A that support its potential as a treatment for obesity. In these studies, BP1001-A attenuated fatty acid-induced insulin resistance and restored insulin sensitivity in muscle progenitor and skeletal muscle fiber cell models, which signal increased potential for BP1001-A as a treatment for obesity and related metabolic diseases in Type 2 diabetes patients.
Updated results from BP1001-A obesity and Type 2 diabetes testing from the second stage of pre-clinical testing are as follows:
- Previously, Bio-Path reported BP1001-A increased insulin sensitivity in myoblast cells (muscle progenitor cells). Skeletal muscle fiber cell models now confirm BP1001-A also increases insulin sensitivity in C2C12 myotubes.
- High fat diet rich in saturated fatty acids can lead to insulin resistance. Palmitic acid, the most common saturated fatty acid in a high fat diet, has been shown to impair insulin signaling. Recent pre-clinical work showed that BP1001-A attenuated palmitic acid-induced insulin resistance and restored insulin sensitivity in C2C12 myoblasts and myotubes.
These data show BP1001-A has increased potential as a treatment for obese patients who have Type 2 diabetes. In the final step of pre-clinical testing, Bio-Path will use a mouse model to assess the impact of BP1001-A on animal weight and its effect on insulin sensitivity and glucose tolerance. If successful, Bio-Path anticipates filing an Investigational New Drug (IND) application in 2025 to initiate a first-in-human Phase 1 clinical trial to further validate safety, measure pharmacokinetics and establish dosing for potential pivotal trials.
“These encouraging pre-clinical results demonstrate BP1001-A’s ability to restore insulin sensitivity in muscle progenitor and skeletal muscle fiber cell models and add to the growing body of evidence supporting this mechanism of action and its potential as a treatment for obesity in Type 2 diabetes patients. The failure of currently available medications to induce weight loss in obese patients who have Type 2 diabetes has created 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. We look forward to initiating our final pre-clinical mouse model study in the first half of 2025 and to filing an IND by year-end.”
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 is conducting preclinical studies to investigate 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.
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. BP1001-A is also being evaluated as a treatment for obesity and related metabolic diseases in Type 2 diabetes patients. 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
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