Repurposing call for chronic respiratory infection

People with bronchiectasis and cystic fibrosis require treatments that address the vicious cycle of infection, inflammation and lung damage. LifeArc will fund innovative projects that seek to develop therapeutics that can be rapidly brought to patients. This could include repurposed or reformulated medicines and deprioritised assets. LifeArc will commit £10m to fund up to five consortia programmes that seek to develop therapeutics that can provide a clear rationale for the use in these conditions. This forms part of LifeArc’s Translational Challenge in Chronic Respiratory Infection and follows from a joint workshop organised by LifeArc and the MRC in May 2022.

Projects should seek to develop treatments that are repurposed, repositioned, including reformulation, or have been deprioritised.

Proposed solutions should target the vicious cycle of infection, inflammation and lung damage, and might include improving muco-ciliary clearance, treating infection, and/or reducing inflammation.

Applicants are encouraged to take a collaborative approach, spanning different disciplines and organisations, to consolidate skills and resources within the research community. Academic institutions, government organisations and SMEs are welcome to apply for funding. Large companies can also take part in consortia, but their costs will not be covered by LifeArc. The lead organisation should be UK-based but participants can be from outside the UK.

In addition to developing the therapeutic agents, projects should include a strategy to develop and validate biomarkers to allow targeted treatment and report outcome. Applications can be at any stage within the development of candidate molecules to clinical stage testing. Novel approaches and use of innovative models that allow rapid translation are encouraged.

All projects should demonstrate a clear pathway to patient care.

New drug discovery projects, high throughput screening, hit to lead discovery and medicinal chemistry development, will not be considered.

Novel approaches are encouraged. Standalone model development and biomarker discovery will not be considered but can be included within applications for the development of the repurposed therapeutic. Sufficient data should be available to justify rapid translation to the clinic, and this may include PK/PD data.

The projects should present a clear rationale with evidence for the use of the existing agent in this context. Due consideration will be paid to intellectual property (IP), ownership of the drugs, current authorisation and the applicants should be able to describe how patients will have downstream access to the drug.

Please click here for the award conditions for the repurposing call.

This funding is part of LifeArc’s Translational Challenge in Chronic Respiratory Infection and follows from a joint workshop organised by LifeArc and the MRC in May 2022. The needs of people with bronchiectasis and cystic fibrosis (CF), beyond treating the infection, were made clear during the workshop. A collaborative approach across organisations and disciplines was also emphasised and this is reflected in the ambitions of the funding programme.

Approaches involving repurposing and reformulation of existing drugs are a more rapid way to bring treatments to patients. This may also include drugs that have been de-prioritised in development but have sufficient justification to allow them to be developed for this use. LifeArc particularly wants to support novel approaches through multi-disciplinary co-operation to bring novel models to bear as well as combining therapeutics with biomarkers.

This funding opportunity will support collaborations that provide a clear rationale for the proposed medicine and can articulate a clear route to patient delivery.

A clear strategy for progress to patients should be described together with relevant access and development of IP.

Proposals must define a substantial, ambitious programme of work with clear potential to catalyse delivery with downstream translatability towards patient treatment. Due consideration should be given to the IP and ownership of the therapeutic. This should be described within the project and if seeking to use a branded medicine involvement of the owner/manufacturer is ideal. Involvement of a manufacturer of a generic drug is also desirable.

Click here for guidance on repurposing medicines

The opportunity is open to academic and industry organisations based in the UK or abroad. The lead organisation must be UK based.

To apply for funding, you must be based at one of the following organisations:

• Academic organisation
• SMEs
• Government organisations such as:
  • public sector research establishment (PSRE)
  • UK Catapult.

Large industrial organisations can apply as co-investigators but may not request funding.

Projects should be collaborative with at least two organisations involved. Applicants will be required to demonstrate that the assembled team have the necessary experience, expertise and access to facilities to deliver the proposed research plan.

The principal investigator should have demonstrable experience in leading multi-investigator and multidisciplinary consortia or, at a minimum, applicants should demonstrate their potential to lead and manage a large-scale collaborative project.

Projects should seek to develop compounds that are repurposed, repositioned, including reformulation, or have been de-prioritised. Proposed solutions should target the vicious cycle of infection, inflammation and lung damage, and should ideally have broad potential benefits for people with CF and bronchiectasis. This might include muco-ciliary clearance, infection, and inflammation. There should be a clear rationale for such use, and the research should be directed at rapid progress to the clinic. The projects should take advantage of molecules that have sufficient data, which may include toxicity and PK/PD, to provide the basis to support rapid progress to patient treatment.

Preferably the development of the therapeutic should be accompanied by inclusion of a strategy for appropriate biomarkers or their development. The use of new models, including limited development, within the scope of progressing the therapeutic is also welcomed but standalone development of either new models or biomarkers will not be eligible for support.

New drug discovery, high throughput screening, hit to lead discovery and medicinal chemistry development, is not eligible for support.

• A new therapy that reduces the vicious cycle of infection, inflammation, and lung damage in people with bronchiectasis and CF.
• The strategy for progress to patients with relevant access to IP is developed.
• The use of the proposed compound is well validated in a relevant disease model, human-based tissue models are particularly relevant.
• The development of the therapeutic is complemented by relevant biomarkers that will improve the use, relevance, and progression of the therapeutic in patients.
• The collaboration is well managed and contributes to the community researching the needs of patients with chronic respiratory infection.
• The next stage of the route to the patient is well-founded and a progression strategy is in place including clinical development, regulatory process, and potential involvement of commercial organisations.

Projects will have a clearly defined scope and a plan that defines the key deliverables. These deliverables will lead to defined milestones and go/no go criteria allowing the project to be tracked to ensure progress to agreed quality/time and cost targets. These will also help to determine the likelihood of achieving the defined outputs and outcomes.

Project progress and payment will be assessed by achievement of milestones that will be monitored within joint steering group meetings, which will include LifeArc representation, throughout the lifecycle of the project.

During the application and at the workshop there will be an opportunity to seek advice and input with regard to various aspects of the application. This may be particularly relevant for describing pathway to the patient, IP considerations, inclusion of biomarker strategy.

A two-stage process is being used to select projects:

• A call for expression of interest (EOI) was open from 22 November 2022 and closed 15 February 2023.
• Submissions were reviewed by a panel in March 2023. Shortlisted applicants have been invited to attend a workshop in London on 5 April 2023 to receive guidance on shaping a successful application. Part of this will involve 1:1s to discuss IP strategy as required.
• Shortlisted applicants will be invited to enter into a confidentiality agreement (CDA) as part of the second stage of the application process. The CDAs will be sent out by LifeArc to the applicants and must be signed in order to progress to the second stage of the application process.
• Full applications must be submitted by 5pm on 31 May 2023.
• Full applications will be subject to due diligence (LifeArc diligence on IP and path to patient/commercialisation as well as review by external and internal peer reviewers).  The full applications and diligence will be considered by an expert panel. Consideration will be given to:
  • the strengths and weaknesses of the application, in the context of the assessment criteria and scoring guidance that the panel will use
  • delivering a balanced assessment of each application
  • the extent that the application is in accordance with LifeArc’s charitable purposes
• Panel review will be completed with decisions communicated during the week of 17  July 2023. While LifeArc will have the ultimate decision-making authority in respect of the applications, it will be strongly guided by the expert panel’s recommendations.
• Successful projects are expected to commence in November 2023.

Click here for guidance on repurposing medicines