ArroyoBannerLLC2

 

What We Do

Idiopathic Pulmonary Fibrosis (IPF)

Healthy_VS_ IFP_Lung

Chronic, progressive, fibrosing interstitial pneumonia of unknown cause.
 

ArroyoHorizBanLine

IPF: Prevalence and Incidence

  • Characteristics
    • 20-30% of all interstitial lung diseases
    • Age >60; males/females 1.6:1
       
  • Prevalence of 90-190K patients US (narrow - broad case definition)
    • Prevalence 28 - 63 /100K population
    • Incidence 8.8 - 17 /100K
    • Numbers increasing over the past 20 years
    • European, Japan diagnosis = 1/3 to 2/3 of US numbers
  • Mortality
    • 40K US deaths/yr; poor prognosis
    • Median survival, < 3 yr from diagnosis; 5 yr survival: 20% (vs 50% with heart failure)
    • 50% due to respiratory failure, half from acute exacerbations
    • Other causes: CVD 57%; cancer 10%, infection 6-10%; renal, liver disease 10-21%
  • Comorbidities
    • Gastroesophageal reflux disease:  87-97%
    • Pulmonary Hypertension:  46% (85% in advanced disease)
    • CAD, heart failure, atrial fibrillation:  57%
    • Lung cancer:  20-31% (IPF is risk factor, potentially causal fibrotic foci)
    • Combined emphysema and fibrosis:  8-28% (esp smokers)

Nalysnyk, Eur Respir Rev, 21: 126, 2012; Lee, Respir Med, 108: 955, 2014; Ryu, Mayo Clin Proc, 89: 11130, 2014

ArroyoHorizBanLine

IPF Competitive Landscape and Costs

The annual IPF-attributable medical cost to the U.S. health Medicare system, excluding medication costs, is estimated at $2 billion*  Only two products are FDA approved for the treatment of IPF

IPFCosts

Annual global sales for IPF medication are expected
to exceed $2B by 2018

* http://www.ncbi.nlm.nih.gov/pubmed/25923447

ArroyoHorizBanLine

IPF Etiology and Intervention

IPF_Etiology_and_Intervention

Ahluwalia, Am J Resp Crit Care Med, 190: 867, 2014

ArroyoHorizBanLine

Greater IPF Efficacy with AB22

  • More potent in Bleomycin-induced fibrosis model
  • Blocks disease progression at 6 different stages
    • S1PR2 acts via multiple IPF/lung cell types
  • Like Nintedanib, blocks TGF-b signaling
    • Also blocks fibrosis independently of TGF-b
  • Blocks S1P induced fibrosis
    • Blocks collagen and CTGF expression in human lung cells
  • Enhances S1P-mediated tissue/wound repair
    • S1P2 antagonist enhanced wound repair in diabetic mice1
  • Blocks mast cell mediated fibrosis and activation 2,3

1J Derm Soc, 48:53, 2007;  2J Exp Med, 207:465, 2010;  3Card. Pulm Ren Path, 182:2094, 2013

ArroyoHorizBanLine

Straight Forward Clinical & Regulatory Pathway

  • PK/PD predict doses for Ph1
  • Dose focusing in Ph1a
  • POC in Ph1b or Ph2
  • Ph3 trials currently utilize ~550 patients, distributed in 2 arms
  • Time for completion, 52 weeks
  • Primary endpoint
    • Annual rate of decline in FVC (decline of >10% surrogate marker of mortality)
    • All cause death
    • All-cause hospitalization
  • Secondary endpoints
    • Time to first exacerbation
    • Cardiovascular events
    • Change in total score of St George Respiratory Questionnaire (SGRQ)

Biomarker and Imaging technology
may allow POC in Ph1b

Mean decline of lung capacity of 150-200 ml/yr in multiple clinical trials for IPF
(= 5.6 - 9.3% FVC decline)

 

Inhaler

Ley, Am J Respir Crit Care Med, 183: 431, 2011

ArroyoHorizBanLine

© Copyright 2018 Arroyo BioSciences, Silver Spring, MD - All Rights Reserved
Web site designed and maintained by Sereni Web Design