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Sanofi/Regeneron's Kevzara Fails in Phase III Coronavirus Study
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Sanofi (SNY - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the phase III study evaluating their IL-6 inhibitor, Kevzara (sarilumab), in hospitalized patients with severe COVID-19 patients failed to meet its primary endpoint. The drug also showed negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline. The study has been stopped following the recommendation of an Independent Data Monitoring Committee (“IDMC”) based on these results.
The U.S.-based study evaluated 400mg dose of Kevzara added to best supportive care compared to best supportive care alone (placebo) for percentage of patients achieving at least a 1-point change from baseline on a 7-point scale based on stages of improvement in patients. The companies were also evaluating a dose of 800mg in another cohort of the study, which was also discontinued along with the study.
The U.S.-based study was led by Regeneron. A similar study is being led by Sanofi outside the United States. The same IDMC, overseeing both studies, recommended continuation of the study outside the United States. Data from this is expected in the third quarter.
Shares of Sanofi and Regeneron were down 3.1% and 1.8%, respectively, in after-market trading on Jul 2 following the announcement. However, Sanofi’s shares have gained 2.8% so far this year against the industry’s decline of 2.2%.
Data from the U.S.-based phase III study showed that treatment with Kevzara achieved minor positive trends but failed to achieve statistical significance in the primary pre-specified analysis group. The group included critical patients who were mechanically ventilated at baseline and receiving 400mg dose of the drug. Moreover, Kevzara also led to negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline.
Serious adverse events and adverse events were also observed in higher proportion of patients compared to placebo.
Apart from Kevzara, Sanofi is also developing vaccines against COVID-19 in collaboration with pharma/biotech companies. Sanofi has also partnered with another large European pharma company, Glaxo (GSK - Free Report) to develop an adjuvant vaccine for COVID-19. The vaccine will be developed using Sanofi’s recombinant DNA technology and Glaxo’s proven pandemic adjuvant technology. The companies plan to initiate a phase I study on the coronavirus vaccine candidate in the second half of 2020.
Sanofi is also developing a mRNA-based vaccine in partnership with Translate Bio (TBIO - Free Report) . First-in-human clinical study on the same is expected to start during the fourth quarter of 2020.
Last month, the company announced creation of a dedicated vaccine center in France with both dedicated to vaccines. This site will enable Sanofi to produce three to four vaccines simultaneously, compared to only one at current industrial sites.
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.1% per year.
These 7 were selected because of their superior potential for immediate breakout.
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Sanofi/Regeneron's Kevzara Fails in Phase III Coronavirus Study
Sanofi (SNY - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) announced that the phase III study evaluating their IL-6 inhibitor, Kevzara (sarilumab), in hospitalized patients with severe COVID-19 patients failed to meet its primary endpoint. The drug also showed negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline. The study has been stopped following the recommendation of an Independent Data Monitoring Committee (“IDMC”) based on these results.
The U.S.-based study evaluated 400mg dose of Kevzara added to best supportive care compared to best supportive care alone (placebo) for percentage of patients achieving at least a 1-point change from baseline on a 7-point scale based on stages of improvement in patients. The companies were also evaluating a dose of 800mg in another cohort of the study, which was also discontinued along with the study.
The U.S.-based study was led by Regeneron. A similar study is being led by Sanofi outside the United States. The same IDMC, overseeing both studies, recommended continuation of the study outside the United States. Data from this is expected in the third quarter.
Shares of Sanofi and Regeneron were down 3.1% and 1.8%, respectively, in after-market trading on Jul 2 following the announcement. However, Sanofi’s shares have gained 2.8% so far this year against the industry’s decline of 2.2%.
Data from the U.S.-based phase III study showed that treatment with Kevzara achieved minor positive trends but failed to achieve statistical significance in the primary pre-specified analysis group. The group included critical patients who were mechanically ventilated at baseline and receiving 400mg dose of the drug. Moreover, Kevzara also led to negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline.
Serious adverse events and adverse events were also observed in higher proportion of patients compared to placebo.
Apart from Kevzara, Sanofi is also developing vaccines against COVID-19 in collaboration with pharma/biotech companies. Sanofi has also partnered with another large European pharma company, Glaxo (GSK - Free Report) to develop an adjuvant vaccine for COVID-19. The vaccine will be developed using Sanofi’s recombinant DNA technology and Glaxo’s proven pandemic adjuvant technology. The companies plan to initiate a phase I study on the coronavirus vaccine candidate in the second half of 2020.
Sanofi is also developing a mRNA-based vaccine in partnership with Translate Bio (TBIO - Free Report) . First-in-human clinical study on the same is expected to start during the fourth quarter of 2020.
Last month, the company announced creation of a dedicated vaccine center in France with both dedicated to vaccines. This site will enable Sanofi to produce three to four vaccines simultaneously, compared to only one at current industrial sites.
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Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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