We are utilising the power of our i-body technology platform to develop a growing pipeline of i-bodies to treat a range of conditions, with an initial focus on treating fibrotic diseases.
Our lead i-body drug candidate AD-114 has significant anti-fibrotic effects in treating a type of fibrosis of the lung, known as idiopathic pulmonary fibrosis (IPF), and this is our initial focus. AD-114 has also demonstrated its usefulness in treating fibrosis of the eye and we are pursuing this as an additional opportunity for treatment of age-related macular degeneration (wet-AMD).
We have broadened the application of AD-114 to other fibrosis indications, including demonstrating therapeutic applications for fibrosis diseases of the liver and skin, and will now move on to demonstrating the anti-fibrotic application of AD-114 in the kidney.
AD-114 has key advantages for IPF treatment. These include:
- only targeting diseased human tissue with effects only shown on IPF tissue and no effects displayed on normal lung tissue nor any evidence of off target effects;
- being more effective than existing IPF approved drugs with greater in vitro efficacy compared to the only approved therapies Nintedanib and Pirfenidone;
- demonstrated efficacy in multiple animal models showing that AD-114 has both anti-fibrotic and anti-inflammatory effects; and
- a novel mechanism of action for fibrosis enabling a “first in class” therapy.
AD-114 effective against Idiopathic Pulmonary Fibrosis (IPF)
IPF is a highly lethal and rare disease with current treatment options only demonstrating a reduction in disease progression. There is no cure. A new, more effective, and longer-lasting treatment regime using i-bodies would bring hope to hundreds of thousands of patients worldwide.
AD-114 has completed extensive pre-clinical studies with positive in vitro (in the lab) and in vivo (in animals) data obtained. For example, in animal lung mouse disease models treated with AD-114, collagen content and inflammatory cell infiltration is substantially reduced thereby demonstrating a similar architecture to that of the normal lung.
Normal lung tissue
IPF lung tissue
(lung disease mouse model)
IPF lung tissue + AD-114 dosed for
21 days showing significant recovery
(lung disease mouse model)
For more information on Idiopathic Pulmonary Fibrosis, please download this PDF, which outlines:
- The disease and how it works;
- The size of the problem / patient population;
- Market dynamics and competitive landscape; and
- AdAlta’s commercialisation approach and data on AD-114.
AD-114 combats Macular Degeneration in the eye
Wet-AMD (age-related macular degeneration) is a leading cause of vision loss in the world with millions of people affected annually. It destroys the macula, the part of the eye that provides sharp, central vision needed for seeing objects clearly. In wet-AMD, blood vessels from behind the retina grow under the macula. These new blood vessels can be fragile and leak blood and fluid causing damage and vision loss. As the disease progresses, patients can experience retinal scarring or fibrosis, which leads to further vision loss.
In collaboration with The University of Melbourne, The Centre for Eye Research Australia and La Trobe University, we have demonstrated that AD-114 has important anti-fibrotic effects in a mouse model of this disease. This data further supports the pre-clinical development of the eye fibrosis indication for AD-114, in a second vitally important area of clinical need.
Please note: We are progressing AD-114 to the clinic as quickly as possible and at this stage we are completing manufacturing of the product and we will then complete additional safety studies in animals before we start our human studies. In the first instance we will then complete studies in healthy volunteers in Australia the second half of 2018, so at this stage we are not recruiting any IPF patients at this stage. Unfortunately AD-114 as a potential treatment for IPF or other pulmonary fibrosis’ is currently not available in any countries.