A day after the announcement by Johnson & Johnson that they were pausing their high-profile trial of its experimental coronavirus vaccine – a further study has now been put on hold – the announcement comes from Eli Lilly who are trialling an antibody drug.
On Tuesday, Lilly said enrolment in a trial of its monoclonal antibody treatment sponsored by the National Institutes of Health (NIH/Anthony Fauci) had been paused due to a potential safety concern.
The Eli Lilly trial was designed to test the benefits of the antibody therapy on hundreds of people hospitalized with Covid-19, compared with a placebo. All of the study participants also received another experimental drug, Remdesivir, which has become commonly used to treat coronavirus patients. It is unclear exactly what safety issues prompted the pause.
The new study is one of four ongoing or planned trials in the National Institutes of Health’s. Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) program, a public-private partnership to speed development of the most promising treatments and vaccine candidates. It is also receiving support through “Operation Warp Speed) the US government’s multi-agency effort to develop, manufacture and distribute medical countermeasures to fight COVID-19.
Through the ACTIV initiative, NIH is pursuing 4 fast-track focus areas most ripe for opportunity, each of which is led by a working group of senior scientists representing government, industry, non-profit, philanthropic and academic organisations.
This government-sponsored clinical trial is similar to the treatment undertaken by US President Donald Trump. President Trump touted the Lilly drug, along with the antibody treatment from Regeneron as tantamount to a cure in a video that he posted.
The Indianapolis-based drug maker did not comment on the implications for the paused trial, called ACTIV-3, which is testing the treatment on COVID-19 patients who require hospitalization, or on its other ongoing trials. It is also testing the drug in nursing homes to see if it can prevent staff and residents from getting infected.
Lilly began its ACTIV-3 trial in August and is aiming to recruit 10,000 patients primarily in the United States. There are 51 sites for this study
While the ACTIV-3 trial remains in limbo, the company said on Wednesday that the Independent Data Safety Monitoring Board that recommended the pause hasn’t called for enrolment to be paused in another government-run trial it is overseeing, known as ACTIV-2.
The treatment is being developed together with Canadian biotech AbCellera.
Just last week, Trump promised to get both Regeneron and Eli Lilly’s drug approved “urgently”
Was the halting of this treatment a political move? – it certainly bears all the hallmarks of President Trump’s previous “game changer” Hydroxychloroquine which was also removed from the trials.
But of course that would be a “tin foil hat” conspiracy theory wouldn’t it?
I fell into politics quite by accident in 2014 and all because my local County Council brought in a policy switching off street lighting overnight my elderly neighbours felt vulnerable – this spurred me into action and the Right to Light Campaign was born.
I started the Right to Light Petition which garnered over 11,000 signatures enough to trigger a debate at Kent County Council. I delivered a speech in front of 88 Councillors and journalists but they refused to listen to the people and kept the lights off.
I worked closely with a local journalist who followed the campaign from start to finish, publishing articles on an almost weekly basis.
Word spread about the campaign and the Council’s refusal to listen – my phone became a hotline, I was invited onto BBC Breakfast and live radio something I would never have contemplated happening in a million years. Following a fierce 2 year battle and against all the odds streetlighting was restored throughout Kent.
Spurred on by success and having witnessed how badly represented people were at local level I joined UKIP standing as a candidate in Borough and County elections narrowly missing out on a seat by 22 votes on one occasion.
The run-up to the EU Referendum was an exciting time I joined the Grassroots Out Campaign and ran weekly street stalls delivering thousands of leaflets and meeting hundreds of people including Nigel Farage and Gerard Batten. I loved the buzz and the fun was infectious. I have been hooked ever since.
I became a prolific poster on Facebook building up relationships in many groups, I was approached by the owner of a Website/FB page called Fortis est Veritas asking if I would like to write articles to post on his platform. I have to date written 22 articles and really enjoy documenting the twists and turns of Brexit a very exciting time – we are writing history and it is essential that is fully documented.
I am very excited to now be given the opportunity to join the UNN family as a Political Analyst – the next chapter in a very exciting 5 years of my life.