Bodhic Health's First-in-Class Treg-Inducing Drug BT-101 Receives FDA IND Approval for Clinical Trial

1Month14Benerhera announces the innovative drug independently developed by the companyBT-101 ObtainedFDAClinical Research Application (IND) approval. The clinical study approved this time is a "first-in-human trial (First-in-Human, FIH")", aimed to evaluate in healthy adult subjectsBT-101 The safety, tolerability, and pharmacokinetic characteristics. The study will be divided into single-dose escalation (SAD`) and multiple-dose escalation (`MAD) Two parts. This breakthrough marks Benerhera's official entry into the clinical development stage.

Benerhera was founded2021Year12Month,ByProfessor Yan Shi of Tsinghua UniversityLeading Creation, the core technology originates from the scientific and technological achievement transformation project of Professor Shi Yan's team.“RegulatoryTApplication of Cells and Modulators in the Prevention and Treatment of Immune System Diseases”, is the first in China to openly layoutRegulatoryTCell (Treg）ImmunotherapyAn innovative biotechnology enterprise dedicated to parsing throughTregCore Molecular Mechanisms of Immunosuppression: Developing Next-Generation Treatment Strategies for Autoimmune and Inflammatory Diseases

BT-101Is a globally pioneering (first-in-class) Potential for Inflammatory Bowel Disease (IBD) in the bodyTreg Inducing agent. This small molecule drug regulates specific components of the intestinal immune system.GProtein-coupled receptor (GPRx), which can specifically promote dendritic cells (DC) function, and induce endogenous initialT Cells differentiate into regulatory cells with potent immunosuppressive functions.T Cell (Treg）。

Compared with traditional in vitro expansion Treg Cell therapy is different,BT-101 Utilizes the oral immune tolerance mechanism to function, with the following significant advantages:

——TargetingIBDPatient Treatment Pain Points:IBDPatients are provided with novel therapeutic drugs to restore immune balance;

——IncreaseTregThe quantity, rather than simple immunosuppression:TregBy controlling the overactivated inflammatory response through various naturally occurring mechanisms in the body, it avoids adverse reactions such as infections secondary to immunosuppressive therapy.

——Phenotypic stability: Induced in situ in the bodyTreg Cells have better epigenetic stability;

——Scalability: In autoimmune and inflammatory diseases,TregThe number and function are reduced, thus improvingTregOral MedicationBT-101Can play a therapeutic role in other autoimmune diseases.

ExceptBT-101In addition, Benerhera's pipeline also includes topical treatments (BT-201), andTregCell Therapy Pipeline (BT-202), etc.

Benerhera Founder, Professor Yan Shi from Tsinghua University School of Medicine, stated:  “BT-101 Obtain FDA The IND Approval is a core milestone in the company's development process.BT-101 By targeting specificGPCR Signaling pathway, aimed at providing patients with autoimmune diseases a more affordable and higher compliance treatment.'Off-the-Shelf'"Medicine. The company looks forward to breakthroughs in scientific research bringing safe and effective treatment options to the vast number of autoimmune patients."

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