This week AstraZeneca (AZN - Free Report) /Oxford University’s coronavirus vaccine candidate entered late-stage development in the United States while Sanofi (SNY - Free Report) /Glaxo (GSK - Free Report) began clinical studies on their adjuvant coronavirus vaccine candidate. Glaxo and partner Vir Biotech’s antibody candidate for COVID-19 also entered clinical studies while Sanofi/Regeneron’s rheumatoid arthritis drug, Kevzara failed in a COVID-19 study.
Recap of the Week’s Most Important Stories
AstraZeneca Begins U.S. Phase III Study on COVID-19 Vaccine Candidate: A phase III study has begun in the United Sates on AstraZeneca/Oxford University’s COVID-19 vaccine candidate, AZD1222. The phase III study will enroll 30,000 adult participants and assess the safety, efficacy and immunogenicity of AZD1222 across all adult age groups and various racial, ethnic and geographic populations. AZD1222 is also being evaluated in late-stage studies in the UK, Brazil and South Africa with studies due to start in Japan and Russia shortly.
Meanwhile, Imfinzi was approved in the European Union for the treatment of patients with extensive-stage small cell lung cancer in combination with etoposide plus a choice of platinum chemotherapy (either carboplatin or cisplatin). The approval was based on data from the phase III CASPIAN study. Imfinzi was approved in the United States for the same indication in the United States in March.
Sanofi/Glaxo’s Adjuvant Coronavirus Vaccine Enters Clinical Studies: Sanofi and Glaxo initiated a phase I/II clinical study on their COVID-19 vaccine candidate, which will enroll 440 healthy adult participants. Sanofi is combining its recombinant protein-based technology with Glaxo’s pandemic adjuvant technology to develop an adjuvanted COVID-19 vaccine. Data from the pre-clinical studies showed promising safety and immunogenicity of the candidate.
Data from the phase I/II study are expected in December. If this data is positive, then the companies plan to start a phase III study in the same month and file for regulatory approval in the first half of 2021. The companies plan to produce 1 billion doses of the adjuvant vaccine in 2021
Glaxo/Vir Biotech’s COVID-19 Antibody Drug Enters Clinical Studies: Glaxo and partner Vir Biotech announced the initiation of a phase II/III study on their monoclonal antibody, VIR-7831 to prevent hospitalization due to COVID-19. The companies expect initial results from the study before the end of the year and expect the candidate to be approved as soon as the first half of 2021. The study is part of a collaboration agreement between Glaxo and Vir Biotechnology signed in April to develop antibody treatments for coronaviruses including SARS-CoV-2.
Sanofi’s Kevzara Fails as Possible COVID-19 Treatment: Sanofi announced that a phase III outside U.S. study evaluating its immunology drug, Kevzara in hospitalized patients with severe and critical COVID-19did not meet its primary endpoint and key secondary endpoint. Data from the study showed that treatment with Kevzara achieved numerical trends toward decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes but failed to achieve statistical significance. Moreover, Kevzara also led to positive trends in reducing mortality in the critical patient group, which was not observed in the severe patient group. Meanwhile, serious infections were observed in 11-13% of patients treated with Kevzara versus 12% in placebo arm.
In July, a Sanofi-led U.S. based phase III study evaluating Kevzara in critical COVID-19 patients also failed to meet its primary and key secondary endpoints and was stopped. Sanofi and partner Regeneron do not plan to conduct any further studies on Kevzara in COVID-19.
J&J Ends Development of Influenza Candidate: J&J (JNJ - Free Report) announced its decision to discontinue development of pimodivir,its investigational antiviral treatment for influenza A infection. Data from an interim analysis of a phase III study on the candidate prompted the company’s decision. Data from this study in hospitalized patients with influenza A indicated that pimodivir in combination with the standard of care (SOC) was unlikely to demonstrate added benefit in this patient population compared to SOC treatment alone. In addition to this study in in hospitalized patients with influenza A, another study in outpatients with influenza A will be stopped.
FDA Approves Higher Doses Lilly’s Trulicity: The FDA granted approval to two higher doses (3 mg and 4.5 mg) of Lilly’s (LLY - Free Report) type-II diabetes injection, Trulicity. The approval was based on data from the AWARD-11 phase III study. 36-week data from the study published in May showed that higher doses of Trulicity pen were well-tolerated and led to A1C reductions of up to 1.9% and weight reductions of up to 10.4 pounds in type II diabetes patients. The additional doses will be available from late September.
The NYSE ARCA Pharmaceutical Index declined 2.2% in the last five trading sessions.
Here is how the eight major stocks performed in the last five trading sessions.
Last week, Roche recorded the highest increase (0.6%) while Pfizer (PFE - Free Report) declined the most (3.9%).
In the past six months, AstraZeneca has risen the most (12%) while Novartis recorded the minimum increase (1.5%).
(See the last pharma stock roundup here: AZN Begins Study on Coronavirus Antibody Combo & Other Updates)
What's Next in the Pharma World?
Watch out for regular pipeline and regulatory updates next week.
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