A Study to investigate MBS2320 in Patients with IPF

• Research type

  Research Study

• Full title

  A Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study to Investigate the Efficacy and Safety of MBS2320 in Patients With Idiopathic Pulmonary Fibrosis (IPF)

• IRAS ID

  1007976

• Contact name

  Kerry Hylands

• Contact email

  Kerry@istesso.co.uk

• Sponsor organisation

  Modern Biosciences Ltd.

• Research summary

  IPF is an interstitial lung disease and one of the most aggressive and common forms of idiopathic interstitial pneumonia. The condition is characterised by chronic progressive lung fibrosis leading to a decline in lung function, progressive respiratory failure and high mortality.
  Complications include increased gastroesophageal reflux disease, coronary artery disease, pulmonary hypertension, dyspnoea and depression. A critical mechanistic feature of the disease is impaired epithelial regeneration after lung injury, driven by dysregulation of alveolar Type 2 cells (AEC2).
  Treatment options for IPF remain limited, with only 2 approved anti-fibrotic therapies available: nintedanib and pirfenidone. Pirfenidone has anti-inflammatory, antioxidant and anti-fibrotic effects and reduces the decline of forced vital capacity (FVC) in patients with IPF. It also shows effects on disease progression, mortality, 6-Minute Walk Test, dyspnoea and respiratory-related hospitalisation. Nintedanib, a tyrosine kinase inhibitor reduces both FVC decline and time to first acute exacerbation but without a clear impact on mortality.
  Despite the impact of both drugs on the decline in FVC, the unmet need remains high, with most patients continuing to experience disease progression and/or exacerbation despite treatment. In addition, both approved therapies are associated with a high adverse-effect burden, including gastrointestinal effects, photosensitivity and the potential for elevations in liver enzymes.
  The purpose of the study is to test a new medicine (MBS2320) for IPF. It is anticipated that MBS2320 can be developed as a once-daily oral therapy for IPF, with a direct impact on alveolar epithelial response, in contrast to the current standard of care (SoC), along with an improved adverse event profile and less frequent administration (once daily versus twice or three times daily for current SoC therapies).
  The study is sponsored by Modern Biosciences Ltd

• REC name

  London - Brighton & Sussex Research Ethics Committee

• REC reference

  23/LO/0675

• Date of REC Opinion

  11 Oct 2023

• REC opinion

  Further Information Favourable Opinion