Supporting the Development and Testing of Therapeutics to Treat COVID-19

Job Description

LifeArc has made available an initial £10M for the identification of therapeutics that can be rapidly deployed to treat COVID-19. The aim is to run trials in patients during the current epidemic. It is anticipated that applications will be for funding to repurpose one or more drugs that are generic, already licensed, or are in late stage development for another indication.

Introduction

COVID-19 now represents a global emergency. Development and testing of a vaccine will take at least a year and it may be two years before there is good protection across the most vulnerable groups. There is a clear need for new treatments that will reduce the mortality rate while we wait for a vaccine.

Development of novel molecules is not thought to be realistic in the timeframe needed to impact upon this pandemic, so the focus for this call is on repurposing already available drugs (including biologics) or those in late stages of development.

The call

LifeArc is calling for applications from academics, NHS employees or companies that have therapeutics that could be repurposed or repositioned for use in COVID-19 patients. The primary purpose is to accelerate availability of treatments for patients and it is therefore expected that applicants will already have material available for testing and a plan for rapid scale up of clinical material. Priority will be given to projects that have a clear path and availability for patients in a 6-12 month timeframe.

Plans for the structure of the clinical trials should be in advanced stages of development and should follow the specialist guidance from the regulators on COVID-19 trials.

The expectation is that the data obtained will be shared openly and, where knowledge obtained could benefit the development of other COVID-19 therapeutics, this should be done as quickly as is reasonably possible.

Eligibility and terms of funding

• Applications from academics, NHS employees, or companies from any geographical location are welcomed.
• Grants will be awarded rapidly under standard, non-negotiable terms. LifeArc will not seek any financial return on these grants. It will not take any equity stakes or other revenue return. It is expected that those receiving funding will respect the spirit of the award and where relevant prioritise COVID-19 patients’ access over any potential for profit.
• The grant will pay for the direct costs of the trials and the science associated with that. There is no official cap on size of applications, however, it is anticipated that a small number of the most promising projects will be funded from the £10M currently available. Applications for funding to supplement existing funding to enable a COVID-19 trial will also be eligible.

Assessment criteria

Applications will be assessed by an expert scientific and clinical panel to ensure that the key aims of the call are delivered. Applications will be assessed against the following criteria:

• Scientific rationale – there must be a clear scientific rationale for why the drug proposed could reasonably be expected to alter the outcome for patients with COVID-19.
• Deliverability of the project within an appropriate timescale. As this epidemic is progressing rapidly, applications for projects that can launch quickly, with all the components necessary already available or in an advanced stage of planning, will likely be more competitive e.g:
  • is the material available or what are the plans for obtaining sufficient clinical quality material?
  • is there a clinical site already associated with the study and how will the study integrate with the clinical care of these patients?
• Trial design – it is important that trials deliver clear meaningful results:
  • What are the endpoints?
  • Are the assays available for measuring those endpoints?
  • Detail on how statistical significance will be assessed and explanation of power calculations should be included in the application
  • Are the plans for patient recruitment realistic?
• Path to patient – if the trial delivers a positive result how will drug or combination of be made available to patients more widely.

Process and timelines

• Call opens 20^th March 2020
• Deadline for applications is 6^th April
• Funding decisions expected week beginning 27^th April
• Funds could be released very rapidly following a funding decision

Please complete the application form to apply to the LifeArc COVID-19 Fund.

You will need to send your completed form to covid19@lifearc.org by 6th April, 2020. We expect to make final funding decisions on the week commencing 27^th April and anticipate releasing funds very rapidly following a confirmed funding decision.