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While still in the final stages of the pre-clinical phase, DUN T1 has already shown remarkable in-vivo study results: We observed significant positive effects on blood glucose levels, disease progression, and animal survival rate.
A doctor in a white lab coat putting on a glove

Medical Background

Type-1 diabetes (T1D) is an autoimmune disease that causes the gradual destruction of insulin-secreting beta cells in the islet cells of the pancreas. It is considered a severe and chronic disease that is incurable. Newly diagnosed patients are offered a variety of effective means for insulin subcutaneous administration but no cures. Their only option is to adapt to a new life of strict dieting, blood-sugar monitoring, and insulin dependence. 

Delay of disease progression, reducing or even delaying insulin reliance is an emerging concept in the landscape of T1D therapy. The first dedicated drug was approved by the FDA in November 2022, and a few others are currently in late clinical development stages. However, most rely on large-molecule biological mechanisms that reduce tissue permeability. Others have immunosuppressive features, which make patients more likely to suffer from adverse reactions or inflammation. Their administration requires intravenous port, hospitalization, and follow-up care to avoid complications associated with immune system suppression.

Our Competitive Advantages

Our therapy was developed with unique advantages in mind, which render it both very safe and highly effective, as we demonstrated in in-vivo studies:

 

  • DUN T1’s modality is based on smaller molecules with better tissue permeability. We demonstrated this modality’s high efficacy in our in-vivo studies.
     

  • DUN T1 is an immunomodulating drug. Immunomodulating drugs typically demonstrate a better safety profile than immunosuppressive medications, which often weaken the body’s immune response and allow recurrent infections. DUN T1’s immune-system mediating effect was demonstrated in our in-vitro studies. 
     

  • DUN T1 is orally administered. Patients in developing countries, who often lack sufficient medical resources, can use it without requiring ongoing medical supervision.


As more countries implement early detection and screening measures for stage 1 and stage 2 T1 diabetes, the need for an affordable and safe intervention that is accessible and easy to administer will soar. 

A female scientist wearing protective glasses and blue gloves, looking through a microscope
A lab technician sitting at a table, taking samples of blue liquids with a microscope visible in the background

Our Methodology

  • After identifying raw potential in a wildcrafted botanical source, we conducted an extensive ethnobotanical survey and selected a botanical strain.

  • Using mass spectrometry, we identified and analyzed candidate active compounds from domesticated species of the field-grown plant.

  • We identified a distinguished Active Botanical Ingredient (ABI) for further purification of active pharmaceutical ingredients and performed a slow-onset T1D animal model to examine it.

  • Preliminary results indicate that DUNT1 inhibits the secretion of pro-inflammatory cytokines from stimulated T cells and provides partial protection against cytokine-induced damage and oxidative stress in vitro. 

  • Our pre-clinical research aims to identify purified active compounds, elucidate their mode of action, and prove appropriate safety and efficacy before advancing to the clinical study phase.

  • DUNT1 significantly reduced blood glucose levels, delayed diabetic onset and disease progression, and increased animal survival.

  • It also significantly reduced proinflammatory cytokine secretion from stimulated human donor T cells.

Successful In-Vivo Study Results

We have recently concluded two years of animal studies with success, having demonstrated overwhelming outcomes for the test group in three key measurable aspects:

  • Maintenance of lower blood glucose levels
    We medicated the control group orally twice daily and regularly measured their blood glucose levels. Results indicated that the treated group maintained lower levels within the normal range over time, while levels in the test groups increased significantly.

  • Delay of disease progression
    While treated and control subjects had developed chronic hyperglycemia, treated subjects showed a significant delay in disease progression in tissue sampling of islet cells.

  • Increased animal survival rate
    Our preliminary results indicated that the overall survival rate was substantially higher in treated animals than in the control group.

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The therapy possesses a dual-action biological mechanism:

  1. It shields the residual insulin-secreting beta cells from elicited damage, therefore maintaining their normal regenerative and functional capacity;
     

  2. It mediates immunomodulation by suppressing the pro-inflammatory response. In clinical settings, we hypothesize that the final pharmaceutical product will delay the inevitable progression of T1D. Consequently, the treatment will reduce insulin reliance and long-term complication severity.

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