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Recent Studies Funded by the Progressive MS Alliance

The Progressive MS Alliance aims to accelerate the development of effective therapies for progressive forms of multiple sclerosis. With funding from 14 MS societies representing 12 countries, the alliance funds research projects focused on better understanding progression, designing faster clinical trials, testing new agents, and developing therapies for symptom management.

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Recent Studies Funded by the Progressive MS Alliance

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  1. Recent Studies Funded by the Progressive MS Alliance Tim Coetzee, PhD ACTRIMS 2016

  2. Disclosures • TC is an employee of the National MS Society • The National MS Society is founding member of the Progressive MS Alliance

  3. Outline • Overview of the Alliance • Collaborative Network Awards Update • Future Plans

  4. Every time another therapy is approved for relapsing MS, a large proportion of our constituents feel left behind

  5. Progressive MS Map Neural Pathways & Mechanisms Immune Mechanisms Symptom Management Purple = Progressive Orange = Non-Progressive

  6. Global Progressive MS Portfolio Distribution of Progressive Projects by Alliance Priority

  7. Global Progressive MS Portfolio Distribution of Projects by Priority/Stage Clinical Trials Clinical Research Discovery Sympt. Mgmt/Rehab Understanding Progression Clin. Trial Designs/Outcomes Dev./Testing of New Agents

  8. Mission: To expedite the development of effective disease modifying and symptom management therapies for progressive forms of multiple sclerosis

  9. 14 MS Societies representing 12 countries

  10. Goals Leverage and coordinate the Global MS movement to focus on Progressive MS Expand the global commitment to progressive MS research by €22 million ($30 million) over the next 6 years Fund research together without considering geography Funding the best science anywhere in the world

  11. Research Priorities Better understand progression so we can identify and test treatments Design shorter, faster trials that measure patient outcomes Conduct trials to test agents Develop and evaluate new therapies to manage symptoms

  12. Sept 2016 Sept 2015 Sept 2013 Sept 2014 Science Strategy Meeting RFA 1 – Challenge & Infrastructure RFA 2 – Collaborative Networks Rehab Meeting Industry stakeholders meeting Industry stakeholders engagement Alliance Scientific Meeting

  13. Collaborative Network Awards Large projects aimed at building global research networks 4 years of funding €1 million/year Each team must at least 3 investigators from 3 countries

  14. Process Summary • Call for submissions November, 2014; closed 31 January 2015 • Worldwide communication and targeted promotion resulted in 52 applications • Involving close to 500 investigators • Peer/Technical review completed in two stages for proposals, with 21 in the second stage • Scientific Steering Committee assessments completed; 11 selected for funding

  15. Collaborative Network Awards – Theme 1 Drug discovery programs that identify and validate molecular and cellular targets and screen and characterize drug candidates, which may be either repurposed or first-in-human drugs. • Expected impact: development of one+ pre-clinical drug candidates within the 4 year funding period of the full network award.

  16. Network Projects:Drug Discovery/Target Discovery/Validation • Quintana • Screen for drug candidates that modulate the activity of immune cells in the central nervous system (astrocytes, microglia and infiltrating macrophages) and identify drug candidates to be analyzed in clinical trials on SPMS patients. • Mahad • Improve the understanding of tissue damage and clinical symptoms in progressive MS and identify pre-clinical candidate drugs using new experimental systems that are relevant to progressive MS

  17. Network Projects:Drug Discovery/Target Discovery/Validation • Goldman • Develop the transplantation of human oligodendrocyte progenitor cells, which as they mature proceed to remyelinate demyelinated axons, as a therapeutic strategy for progressive MS • Martino • Bioinformatics to discover new drugs for progressive Multiple Sclerosis and to identify molecules that might have a therapeutic protective role on neurons and/or the capacity of favoring the proliferation of myelinatingcells

  18. Network Projects:Drug Discovery/Target Discovery/Validation • Hafler-De Jager • Identify genes that predispose to MS, examine in large patient cohorts from around the world if patients who carry these genes have a higher chance to develop severe progression and establish if patients with these genes respond to specific treatments that target that genetic dysfunction.

  19. Collaborative Network Awards – Theme 2 The discovery, advancement and validation of new or existing biological or imaging biomarkers. • Expected Impact: development of a meaningful outcome measure that could be integrated into early clinical development within the 4 year funding period.

  20. Network Projects:Biomarkers – Biological/Imaging • Arnold • Develop new MRI outcome measures that could provide a more efficient preliminary readout of drug efficacy, i.e., that could be used in smaller, shorter trials that would cost much less money • Filippi • Determine and validate novel cervical cord MRI biomarkers to be utilized as predictors and/or outcomes in future studies of progressive MS

  21. Network Projects:Biomarkers – Biological/Imaging • Lublin • The discovery, advancement and validation of new or existing biological or imaging biomarkers leading to development of a meaningful outcome measure that could be integrated into early clinical development within the 4 year funding period.

  22. Network-Projects:Biomarkers – Biological/Imaging • Stankoff-Nicholas • Develop and apply in clinical studies new imaging probes (PET) that will allow the quantification of cells involved in inflammation and remyelination. • Fuhr-Calabresi • The goal of these projects are to develop and validate the utility of different methods (precise tools) to measure disease progression and perform clinical trials more efficiently.

  23. Collaborative Network Awards – Theme 3 Proof-of-concept trials and proof of concept trial designs, including, but not limited to trials in remyelination, neuroprotection, enhanced plasticity or other first-in-human, exploratory clinical trials for progressive MS • Expected impact: initiation of clinical trials of new interventions for progressive MS within the 4 year funding period.

  24. Network Projects:Clinical Trials (Designs/Rehabilitation) • Feinstein-Leocani • The goal of this proposal is to undertake rehabilitation studies in people with progressive MS and attempt to address some of the questions about what might represent the most effective approach to symptom management.

  25. Sept 2016 Sept 2015 Sept 2013 Sept 2014 Science Strategy Meeting RFA 1 – Challenge & Infrastructure RFA 2 – Collaborative Networks Rehab Meeting Industry stakeholders meeting Industry stakeholders engagement Alliance Scientific Meeting

  26. Looking Ahead Convene additional scientific meetings and workshops in focus areas Continue to develop the Industry Forum Connect and coordinate global research efforts in progressive MS Identify new funding strategies to accelerate progress

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