AstraZeneca’s AZD7442 to enter Phase 3 clinical trials for Covid-19 prevention and treatment

AstraZeneca has announced the progression of its monoclonal antibody combination, AZD7442, into two pivotal Phase 3 clinical trials. This long-acting antibody (LAAB) combination is being evaluated for both the prevention and treatment of Covid-19, marking a significant step in the pharmaceutical giant’s efforts to combat the global pandemic. With more than 6,000 participants slated for recruitment, these trials aim to assess the effectiveness and safety of AZD7442 in diverse settings, as AstraZeneca seeks to deliver a long-lasting solution to the ongoing Covid-19 crisis.

AZD7442: A Promising Candidate for Covid-19

AZD7442 is a combination of two monoclonal antibodies (mAbs) derived from convalescent patients who recovered from SARS-CoV-2 infection. These antibodies are designed to specifically target the spike protein of the virus, preventing it from entering human cells. The dual mechanism of action is aimed at reducing the risk of resistance, which can be a challenge in the treatment of viral infections.

The long-acting antibodies are engineered using AstraZeneca’s proprietary half-life extension technology, which enables the antibodies to remain effective for 6 to 12 months following a single administration. This extended duration of action makes AZD7442 a potential game-changer for Covid-19 prevention, especially for high-risk individuals who may not be able to receive a vaccine or those in need of immediate protection after exposure to the virus.

Phase 3 Trials to Evaluate Safety and Efficacy

The Phase 3 clinical trials for AZD7442 will take place across several sites in the United States and other locations worldwide. These trials are set to assess both the preventive and therapeutic potential of the antibody combination.

The first of the two trials will evaluate the safety and efficacy of AZD7442 for the prevention of Covid-19, enrolling nearly 5,000 participants. The trial will track participants over a 12-month period to determine how well the antibody combination can provide long-term protection against the virus. This trial is crucial in establishing AZD7442 as a viable option for preventing Covid-19, especially in vulnerable populations.

The second trial will focus on the use of AZD7442 as a post-exposure prophylaxis (PEP) and pre-emptive treatment, enrolling around 1,100 participants. This study will assess the ability of AZD7442 to reduce the severity of infection and prevent the onset of symptomatic Covid-19 after exposure to the virus. These trials are particularly important for providing treatment options for individuals who may not have access to vaccines or those who experience breakthrough infections after vaccination.

In addition to these two trials, AstraZeneca plans to conduct further studies involving nearly 4,000 participants to explore AZD7442’s potential in treating active Covid-19 infections, offering additional avenues for therapeutic use.

Strategic Government Support and Partnerships

AstraZeneca’s push for AZD7442’s widespread use is supported by significant government funding. In June 2020, the company secured a licensing agreement with Vanderbilt University Medical Center for the development of the monoclonal antibody combination. Subsequently, AstraZeneca received nearly $486 million in funding from the U.S. government under an agreement with the Biomedical Advanced Research and Development Authority (BARDA). This financial backing is intended to accelerate the development and distribution of AZD7442, with an initial goal of supplying 100,000 doses by the end of 2024.

As part of the arrangement, the U.S. government also has the option to purchase up to an additional one million doses of AZD7442 in 2025, ensuring that the antibody combination is available for broader public health needs, including the prevention and treatment of Covid-19. Pascal Soriot, CEO of AstraZeneca, expressed optimism about the partnership, noting the potential of AZD7442 to provide both immediate and long-lasting protection against Covid-19.

“This agreement with the U.S. Government will help accelerate the development of our long-acting antibody combination which has the potential to provide immediate and long-lasting effect in both preventing and treating COVID-19 infections,” said Soriot. “We will be evaluating the LAAB combination in different settings from prophylaxis, to outpatient treatment to hospitalisation, with a focus on helping the most vulnerable people.”

The Road Ahead for AZD7442

As AstraZeneca moves forward with its clinical trials and prepares for the distribution of AZD7442, the company remains focused on providing a solution to the ongoing Covid-19 pandemic. The combination of monoclonal antibodies presents a promising option for preventing and treating the virus, particularly as new variants continue to emerge. If successful, AZD7442 could become an important tool in the global fight against Covid-19, alongside vaccines and other antiviral treatments.

With the support of government partners and the ongoing clinical trials, AZD7442 could play a pivotal role in the management and control of the Covid-19 pandemic, offering a potentially long-term solution for those at risk of infection and disease progression. The outcomes of these trials will be closely watched by the scientific community, healthcare professionals, and governments around the world, as they could pave the way for new standards of care in the fight against Covid-19.