Bio-Path Holdings Achieves Third Pre-Clinical Milestone Confirming Potential of BP1001-A as Treatment for Obesity in Type 2 Diabetes Patients
Bio-Path Holdings (BPTH) ha raggiunto il suo terzo traguardo pre-clinico per BP1001-A, dimostrando il suo potenziale come trattamento per l'obesità nei pazienti con diabete di tipo 2. Gli ultimi studi evidenziano che BP1001-A impedisce alle cellule di sviluppare resistenza all'insulina e ripristina l'attività ridotta di AKT nelle cellule epatiche. Il farmaco agisce riducendo l'espressione di Grb2, contribuendo così ad attenuare la resistenza all'insulina indotta dall'acido palmitico e a ristabilire la segnalazione insulinica nei modelli cellulari muscolari ed epatici.
L'azienda procederà con i test pre-clinici finali utilizzando un modello murino per valutare l'effetto di BP1001-A sul peso animale, la sensibilità all'insulina e la tolleranza al glucosio. In caso di esito positivo, Bio-Path prevede di presentare una domanda IND nel 2025 per avviare gli studi clinici di Fase 1.
Bio-Path Holdings (BPTH) ha alcanzado su tercer hito preclínico para BP1001-A, demostrando su potencial como tratamiento para la obesidad en pacientes con diabetes tipo 2. Los estudios más recientes muestran que BP1001-A previene que las células desarrollen resistencia a la insulina y recupera la actividad reducida de AKT en células hepáticas. El medicamento actúa disminuyendo la expresión de Grb2, lo que ayuda a mitigar la resistencia a la insulina inducida por ácido palmítico y a restaurar la señalización de la insulina en modelos celulares musculares y hepáticos.
La empresa continuará con las pruebas preclínicas finales utilizando un modelo de ratón para evaluar el impacto de BP1001-A en el peso animal, la sensibilidad a la insulina y la tolerancia a la glucosa. Tras una finalización exitosa, Bio-Path planea presentar una solicitud IND en 2025 para iniciar los ensayos clínicos de Fase 1.
Bio-Path Holdings (BPTH)는 BP1001-A에 대한 세 번째 비임상 마일스톤을 달성하며 제2형 당뇨병 환자의 비만 치료제로서의 가능성을 입증했습니다. 최신 연구 결과 BP1001-A는 세포가 인슐린 저항성을 갖는 것을 방지하고 간세포에서 감소된 AKT 활성을 회복시킵니다. 이 약물은 Grb2 발현을 억제하여 팔미트산에 의해 유도된 인슐린 저항성을 완화하고 근육 및 간세포 모델에서 인슐린 신호 전달을 복원하는 작용을 합니다.
회사는 쥐 모델을 사용한 최종 비임상 시험을 진행하여 BP1001-A가 동물의 체중, 인슐린 감수성 및 포도당 내성에 미치는 영향을 평가할 예정입니다. 성공적으로 완료되면 Bio-Path는 2025년에 IND 신청서 제출를 계획하여 1상 임상시험을 시작할 것입니다.
Bio-Path Holdings (BPTH) a atteint son troisième jalon préclinique pour BP1001-A, démontrant son potentiel en tant que traitement de l'obésité chez les patients atteints de diabète de type 2. Les dernières études montrent que BP1001-A empêche les cellules de devenir résistantes à l'insuline et restaure l'activité réduite d'AKT dans les cellules hépatiques. Le médicament agit en régulant à la baisse l'expression de Grb2, ce qui aide à atténuer la résistance à l'insuline induite par l'acide palmitique et à restaurer la signalisation de l'insuline dans les modèles cellulaires musculaires et hépatiques.
L'entreprise procédera aux derniers tests précliniques en utilisant un modèle murin pour évaluer l'impact de BP1001-A sur le poids animal, la sensibilité à l'insuline et la tolérance au glucose. En cas de succès, Bio-Path prévoit de déposer une demande d'IND en 2025 afin de débuter les essais cliniques de phase 1.
Bio-Path Holdings (BPTH) hat seinen dritten präklinischen Meilenstein für BP1001-A erreicht und damit das Potenzial als Behandlung von Fettleibigkeit bei Typ-2-Diabetes-Patienten demonstriert. Neueste Studien zeigen, dass BP1001-A verhindert, dass Zellen insulinresistent werden, und die verringerte AKT-Aktivität in Leberzellen wiederherstellt. Das Medikament wirkt, indem es die Expression von Grb2 herunterreguliert, was hilft, die durch Palmitinsäure induzierte Insulinresistenz abzuschwächen und die Insulinsignalisierung in Muskel- und Leberzellmodellen wiederherzustellen.
Das Unternehmen wird mit abschließenden präklinischen Tests an einem Mausmodell fortfahren, um die Auswirkungen von BP1001-A auf das Körpergewicht, die Insulinsensitivität und die Glukosetoleranz zu bewerten. Nach erfolgreichem Abschluss plant Bio-Path, 2025 einen IND-Antrag einzureichen, um mit klinischen Phase-1-Studien zu beginnen.
- Successful achievement of third pre-clinical milestone for BP1001-A
- Demonstrated effectiveness in preventing insulin resistance in liver and muscle cells
- Potential therapeutic application for both obesity and Type 2 diabetes treatment
- Plans to advance to IND application in 2025 following mouse model studies
- Still in early pre-clinical stage with no human trials yet
- Final mouse model testing still pending before IND application
- Success in cell models may not translate to effective treatment in humans
Insights
Bio-Path's third pre-clinical milestone shows promising cellular mechanism for insulin resistance, but remains years from potential clinical use.
Bio-Path's announcement represents meaningful progress in their pre-clinical program targeting obesity in Type 2 diabetes patients. The third milestone shows BP1001-A successfully rescues decreased AKT activity in liver cells exposed to palmitic acid, complementing their previous findings in muscle cell models. This methodical approach—validating results across multiple cell types relevant to insulin resistance—follows standard drug discovery practices.
The company's DNAbilize® platform, which uses liposomal delivery of antisense oligonucleotides, is being applied to downregulate Grb2, a protein involved in insulin signaling pathways. The consistency of results across different cell models (myoblasts, myotubes, and now liver cells) suggests the mechanism may be broadly applicable to multiple tissues affected by insulin resistance.
However, investors should recognize these are early-stage findings limited to in vitro studies. The crucial transition to animal models hasn't occurred yet, which represents a substantial hurdle before human testing. Cell-based studies frequently identify promising candidates that subsequently fail in animal or human testing.
The planned IND filing in 2025 would mark only the beginning of human trials, positioning this program years from potential market approval. While this milestone represents continued validation of their approach, significant technical, regulatory, and financial challenges remain before BP1001-A could become a commercial product for obesity treatment.
Novel mechanism targeting insulin resistance at the cellular level shows promise, but faces significant translational hurdles ahead.
The molecular approach demonstrated in these pre-clinical studies targets a fundamental mechanism in insulin resistance. By downregulating Grb2 expression, BP1001-A attenuates the negative effects of palmitic acid on insulin signaling pathways, as evidenced by restored AKT activity in multiple cell types.
From a metabolic perspective, this is scientifically sound. AKT (protein kinase B) is central to insulin's metabolic actions, regulating glucose uptake, glycogen synthesis, and suppression of gluconeogenesis. The sequential validation in muscle cells (both myoblasts and differentiated myotubes) and now liver cells (HepG2) addresses two major insulin-responsive tissues implicated in Type 2 diabetes pathophysiology.
This molecular approach differs conceptually from current obesity therapeutics that primarily target appetite regulation or incretin response. By addressing insulin resistance directly at the cellular level, BP1001-A could potentially complement existing therapies.
However, these findings face significant translational challenges. The planned mouse studies represent a critical step to assess systemic delivery, in vivo efficacy, and effects on weight, insulin sensitivity, and glucose tolerance. The focus on palmitic acid-induced insulin resistance represents just one aspect of the complex pathophysiology of obesity and diabetes.
The cell culture models, while valuable, cannot recapitulate the complex interplay between multiple organs and systems involved in metabolic regulation. Even with positive animal data, human metabolism presents additional complexities that will need to be addressed in clinical trials.
Data suggest BP1001-A prevents fatty acid-induced insulin resistance in cells
HOUSTON, May 01, 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 the achievement of a third milestone from recent preclinical studies of BP1001-A that provide additional support for its potential as a treatment for obesity. These studies showed BP1001-A rescues the decrease in AKT activity in liver cells and prevents cells from becoming insulin resistant, confirming its potential as a treatment for obesity and related metabolic diseases in Type 2 diabetes patients.
A 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 in skeletal muscle and liver. Accordingly, Bio-Path has focused preclinical testing of BP1001-A in C2C12 myoblasts (a muscle progenitor cell model), C2C12 myotubes (a skeletal muscle fiber cell model), and HepG2 cells (a liver cell model).
“Our most recent pre-clinical results show BP1001-A rescues the decrease in AKT activity in liver cells to measurements associated with Palmitic acid treatment,” said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. “These results give us further confidence in the potential of BP1001-A to prevent cells from becoming insulin resistant and, ultimately, as an effective treatment for obese patients who have Type 2 diabetes.”
Bio-Path previously announced that by downregulating Grb2 expression, BP1001-A attenuated palmitic acid-induced insulin resistance and restored insulin signaling in C2C12 myoblasts and myotubes. Preliminary results showed similar results in HepG2 cells with BP1001-A restored insulin signaling in HepG2 cells treated with palmitic acid. These data showed that BP1001-A could potentially help skeletal and liver cells from becoming insulin resistant and BP1001-A is a potential 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.
About BP1001-A
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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