NXP002 (inhaled tranilast) for IPF -preclinical

NXP002 is our lead asset and a potential novel inhaled treatment for idiopathic pulmonary fibrosis

  • Repurposed new form of the drug tranilast, to be delivered in an inhaled formulation.
  • Tranilast has a long history of safe use as an oral drug for allergies but there is evidence (widely published in peer reviewed scientific papers) that supports its potential in fibrosis, including IPF.
  • Overall findings suggest that tranilast inhibits pulmonary fibrosis by suppressing TGFβ/SMAD2-mediated extra-cellular matrix (ECM) protein  production, a major therapeutic target in IPF, presenting it as a promising and novel anti-fibrotic agent. 1
  • NXP002 is differentiated as it is a new form of tranilast and will be formulated for delivery direct to the lungs by inhalation, a new route of administration for this drug.
  • Delivery by the inhalation route is a well-known strategy for treatment of lung diseases to yield greater efficacy and reduce systemic side-effects compared to oral treatment.
  • We have filed two patent applications on new forms of tranilast, one of which is granted and the other is issued in the US and undergoing examination in other territories.
  • Our studies have yielded positive data underpinning the potential of NXP002 as an IPF treatment, including potential for use in combination with standard of care therapy and support continuing to develop this asset.
  • Our studies have yielded positive data underpinning the potential of NXP002 as an IPF treatment, including potential for use in combination with standard of care therapy and support continuing to develop this asset.
    • The first of these studies demonstrated that NXP002 can be efficiently delivered to the lung, achieving significant drug levels, whilst limiting systemic exposure compared to oral dosing
    • The second in vivo study evaluated the pharmacodynamics of NXP002 when delivered by nebulisation. This study showed that inhaled NXP002 could dose-dependently regulate the production of fibrosis-relevant mediators

The final planned study as part of the NXP002 pre-clinical data package is an in vivo study investigating the durability of the pharmacodynamic effect. The Company anticipates receiving the data for this study in early 2022 prior to seeking licensing/partnering opportunities.