Member Info for Ducati2

We are in the FAST LANE!

https://www.bioworld.com/articles/499587-bio-europe-taking-stock-of-the-covid-19-pipeline

The U.K. government is conferring urgent public health research status on select programs, which offers a kind of fast-lane to the most promising programs. Synairgen’s inhaled formulation of interferon-beta, SNG-001, recently received that designation.

Speaking during the same session, Richard Marsden, CEO of Southampton, U.K.-based Synairgen plc, identified a role for governments in tackling this problem. “If you’re just embarking on phase II trials now, you’re going to struggle to find sites and find patients,” he said. “A tricky thing that governments might have to do is kind of ration where drugs can get assessed in different trial sites.” The U.K. government is conferring urgent public health research status on select programs, which offers a kind of fast-lane to the most promising programs. Synairgen’s inhaled formulation of interferon-beta, SNG-001, recently received that designation. “Without it, you’d have to walk past the U.K., because you’re not going to get many people recruited into your clinical trial.” It’s a necessary intervention, given the urgent need to generate high-quality clinical data as quickly as possible. “Otherwise, everyone is going to end up with 50 or 60 patients in their trials, and we’ll all be scratching our heads trying to work out what worked and what didn’t work.”

Don’t think we have access to view once published, could be interesting. Friday 30th.

https://www.uhs.nhs.uk/ClinicalResearchinSouthampton/Research/COVID-19/BRC-COVID-19-Science-Forum.aspx

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)32175-9/fulltext

https://www.synairgen.com/wp-content/uploads/2020/10/Synairgen-FR-presentation-for-Website.pdf

Phase III randomised placebo-controlled trial of SNG001 in hospitalised COVID-19 patients
• Pre-IND meeting held with FDA. IND to be filed shortly
• Interaction with EMA ongoing
• 900 patients with OSCI score of 4 to be randomised, using the Aerogen Solo/Ultra nebuliser
– 300 patients with one syringe of SNG001
– 300 patients with two syringes of SNG001
– 300 patients with Placebo
• Dosing: Once daily dosing for 14 days in all arms
• Primary endpoint
– Time to Recovery to ‘No Limitation of Activities’ up to Day 28 • Secondary endpoints
– Endpoints based on OSCI o Worsening disease
o Discharge from hospital – Breathlessness
• Safety assessment

Pmjh great stuff.

https://www.theyworkforyou.com/wrans/?id=2020-09-21.92795.h&s=c

Have been requested!

Synairgen have been requested to submit a formal submission to UK-CTAP and NIHR UPH for review, where the inhaled interferon beta-1, SGN001 will be reviewed by a panel of independent experts to assess if it will be suitable to be incorporated into the RECOVERY+ trial or an independent trial, for Phase III.

https://www.globenewswire.com/news-release/2020/10/27/2115020/0/en/BetterLife-CEO-Highlights-Crucial-Difference-Between-the-Company-s-Interferon-Alpha-2b-and-Other-Treatements.html

https://www.hospimedica.com/covid-19/articles/294785231/closed-circuit-nebulizer-technology-to-help-deliver-potential-covid-19-inhaled-therapies.html

As below, just taking up my share offer from HL today.........

HL gives you until noon on Wednesday 28 October 2020.

https://www.globenewswire.com/news-release/2020/10/20/2110915/0/en/Parexel-Biotech-Collaborates-with-Synairgen-on-Pivotal-Phase-III-Trial-for-Study-of-Inhaled-COVID-19-Treatment.html

https://www.cnbc.com/2020/10/25/coronavirus-mark-meadows-says-were-not-going-to-control-the-pandemic-.html

https://www.dailymail.co.uk/news/article-8878251/12-minute-Covid-test-expected-available-Boots-weeks.html

Pge 123

https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf

Woodstock

Oxford coronavirus vaccine 'has only been tested on 500 over-70s' amid fresh concerns over its effectiveness!!

Britain's front-running Covid vaccine has only been tested on about 500 elderly people in this country, raising questions about how effective it might be for a vital section of the population.

There are high hopes for Oxford University's 'ChAdOx' jab but only 1,000 or so of the 10,000 people recruited to the UK arm of Oxford's trial are aged 70 or over. Half of them have been given the vaccine and half have had a placebo.

Last night, former immunisation 'tsar' Professor David Salisbury said the relatively small numbers might not be enough to generate a meaningful result.

Plans are being drawn up for frontline NHS staff to receive a coronavirus vaccine within weeks, as the Government moves to accelerate the timetable for a mass roll-out. An email sent by an NHS Trust chief to his staff, seen by The Mail on Sunday, reveals the Health Service is preparing for a national vaccination programme before Christmas. It can also be disclosed that the Government has introduced new laws that would allow the UK to bypass the EU approval process if a safe and effective jab is ready before the end of the post-Brexit transition period on December 31. The move will boost optimism that a 'game-changing' vaccine will soon allow Boris Johnson to relax the social restrictions which have crippled the country since March

https://www.dailymail.co.uk/news/article-8874173/Rapid-Covid-tests-deliver-results-15-minutes-available-little-5.html

https://www.dailymail.co.uk/news/article-8873559/UK-Government-blasted-refusing-extend-VAT-freeze-medical-PPE.html

https://www.parexel.com/news-events-resources/news/current/parexel-biotech-collaborates-synairgen-pivotal-phase-iii-trial-study-inhaled-covid-19-treatment

https://www.dailymail.co.uk/news/article-8871399/Number-daily-coronavirus-cases-Europe-doubles-200-000.html

https://www.businesswire.com/news/home/20201022006039/en/Aerogen-Collaborates-on-Development-of-More-Than-15-Potential-COVID-19-Inhaled-Therapies

https://www.irishtimes.com/business/health-pharma/galway-s-aerogen-plays-key-role-in-covid-19-therapies-1.4388423