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Given the reported "distinct advantages" of TILS drug candidate, any early positive trial data from Sanofi, will no doubt greatly increase investor interest here imho. Gla ;-)
Sanofi's Kevzara patient trials underway.....Gla ;-)
Sanofi and Regeneron are currently exploring the use in this setting of Kevzara, another FDA-approved anti-IL-6 receptor arthritis therapy.
Tiziana, meanwhile, will start assessing the drug in patients as soon as is practicable and will administer TZLS-501 using its proprietary formulation technology.
It said the features of its drug candidate should provide it with distinct advantages other anti-IL-6R mAbs such as Actemra and Kevzara in treating severely affected COVID-19 patients.
The aforementioned advantages are TZLS-501s dual mechanism of action to inhibit signalling by the membrane-bound and soluble IL-6 receptors along with the rapid depletion of circulating IL-6 cytokine, a major cause of lung damage.
We are excited to move forward with our clinical development plan to expedite evaluation in patients as soon as possible", said Tiziana's chief executive Dr Kunwar Shailubhai.
Gabriele Cerrone, chairman, added that Tiziana only became aware of the potential of its anti-IL6R mAb after people in Naples with lung problems caused by coronavirus started to respond to treatment with Actemra.
We are sitting on one of best anti-IL6R monoclonal antibodies on the market but had no idea it could be used for Covid-19 complications on the respiratory system as no-one had ever tried it before.
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Monday 30 March, 2020
Sanofi: First patient outside U.S. treated in global Kevzara® (sarilumab) clinical trial program for patients with severe COVID-19
Phase 2/3 trial initiated in Italy, Spain, Germany, France, Canada and Russia and is enrolling patients immediately
Kevzara inhibits IL-6, which may play a role in driving the inflammatory immune response that causes acute respiratory distress syndrome observed in patients with severe COVID-19 infection
Sanofi is leading trials outside the U.S., while Regeneron is leading U.S. trials
PARIS and TARRYTOWN, N.Y. – March 30, 2020 – The first patient outside of the U.S. has been treated as part of a global clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19. The global clinical program has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the United States – all countries that have been impacted by COVID-19.
This is the second multi-center, double-blind, Phase 2/3 trial as part of the Kevzara COVID-19 program, and the companies are continuing to work with health authorities around the world to secure initiation at additional sites. This follows Sanofi and Regeneron’s announcement earlier this month of the initiation of the first trial, which is U.S.-based.
https://www.investegate.co.uk/sanofi/gnw/sanofi--first-patient-outside-u-s--treated-in-global-kevzara--174---sarilumab--clinical-trial-program-for-patients-with-severe-covid-19/20200330060000H7883/