Roche announces collaboration with Atea Pharmaceuticals to develop a potential oral treatment for COVID-19 patients
- Roche
and Atea partner to jointly develop AT-527, an orally administered direct-acting
antiviral (DAA) currently in Phase 2 clinical trials
- AT-527
has the potential to be the first novel oral antiviral to treat COVID-19
patients outside the hospital setting as well as in the hospital and may
also be used in post-exposure prophylactic settings
- Oral,
small-molecule DAAs for COVID-19 patients allow for large-scale
manufacturing and facilitate broad patient access
- If
approved, Atea will distribute AT-527 in the United States and Roche will
be responsible for global manufacturing and distribution outside the
United States
Basel, 22
October 2020 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Atea Pharmaceuticals,
Inc. announced today that they are joining forces in the fight against COVID-19
to develop, manufacture and distribute AT-527, Atea’s investigational oral
direct-acting antiviral, to people around the globe. AT-527 acts by blocking
the viral RNA polymerase enzyme needed for viral replication, and is currently
being studied in a Phase 2 clinical trial for hospitalised patients with
moderate COVID-19. A Phase 3 clinical trial, expected to start in Q1 2021, will
explore the potential use in patients outside of the hospital setting. In
addition, AT-527 may be developed for post-exposure prophylactic settings.
AT-527, while being a potential oral treatment option for hospitalised
patients, also holds the potential to be the first oral treatment option for
COVID-19 patients that are not hospitalised. Additionally, the
manufacturing process of small-molecule DAAs allows the ability to produce
large quantities of a much needed treatment. If successful, AT-527 could help
treat patients early, reduce the progression of the infection, and contribute
to decreasing the overall burden on health systems.
The collaboration aims to accelerate the clinical development and manufacturing
of AT-527, to investigate its safety and efficacy, and to provide this
potential treatment option to patients around the world as quickly as possible.
If AT-527 proves safe and effective in clinical trials and regulatory approvals
are granted, Atea will be responsible for distributing this treatment option in
the U.S, with the option to request Genentech’s support, and Roche will be
responsible for distribution outside the United States.
"The ongoing complexities of COVID-19 require multiple lines of defence.
By joining forces with Atea, we hope to offer an additional treatment option
for hospitalised and non-hospitalised COVID-19 patients, and to ease the burden
on hospitals during a global pandemic." said Bill Anderson, Chief
Executive Officer of Roche Pharmaceuticals. "In jointly developing and
manufacturing AT-527 at scale, we seek to make this treatment option available
to as many people around the world as we possibly can."
“Roche shares our passion for delivering innovative new medicines to address
great unmet medical needs. The COVID-19 pandemic has highlighted the urgent
need for a novel, oral antiviral to treat this highly infectious and often
deadly virus,” said Jean-Pierre Sommadossi, Ph.D., Chief Executive Officer and
Founder of Atea Pharmaceuticals. “AT-527 is expected to be ideally suited to
combat COVID-19 as it inhibits viral replication by interfering with viral RNA
polymerase, a key component in the replication machinery of RNA viruses.
Importantly, the manufacturing process for our small molecule direct-acting
antiviral allows us to produce AT-527 quickly and at scale.”
About AT-527
AT-527 is an investigational, oral, purine nucleotide prodrug, which has
demonstrated in vitro and in vivo antiviral activity against several enveloped
single-stranded RNA viruses, including human flaviviruses and coronaviruses.
This highly selective purine nucleotide prodrug was designed to uniquely
inhibit viral RNA dependent RNA polymerase, an enzyme that is essential for the
replication of RNA viruses. Antiviral activity and safety of AT-527 has been
demonstrated in Phase 2 clinical studies of hepatitis C patients, and in
preclinical in-vitro assays with SARS-CoV2 virus. AT-527 is not yet
licensed or approved for any indication in the United States or any other
country.
About Roche’s response to
the COVID-19 pandemic
As a leading healthcare company we are doing all we can to support countries in
minimising the impact of COVID-19. We have developed a growing number of
diagnostic solutions that help to detect and diagnose the infection in
patients, as well as providing digital support to healthcare systems, and we
continue to identify, develop and support potential therapies which can play a
role in treating the disease.
We understand the impact of COVID-19 goes beyond those who contract it, which
is why we are working with healthcare providers, laboratories, authorities and
organisations to help make sure that patients continue to receive the tests,
treatment and care they need during these challenging times. As we learn from
the pandemic, we are partnering with governments and others to make healthcare
stronger and more sustainable in the future.
Our diagnostics solutions:
Reliable, high-quality testing is essential to help healthcare systems overcome
this pandemic. Our portfolio includes:
- a
high-volume molecular test to detect SARS-CoV-2, the virus that causes
COVID-19, (FDA Emergency Use Authorisation (EUA) and available in
countries accepting the CE Mark)
- a SARS-CoV-2
laboratory-based antibody test, aimed at detecting the presence of
antibodies in the blood targeting the nucleocapsid (FDA EUA and CE Mark)
- an IL-6 test
to assist in identifying severe inflammatory response in patients with
confirmed COVID-19 (FDA EUA and CE Mark)
- Roche v-TAC,
which could help simplify the screening, diagnosis and monitoring of
patients with respiratory compromise in the current COVID-19 pandemic
- a SARS-CoV-2
rapid antibody test to help determine at the point of care whether a
person has been exposed to the virus (CE Mark)
- a rapid
antigen test to support in the detection of SARS-CoV-2 at the point of
care within 15 minutes (CE Mark)
- a
high-volume molecular test to simultaneously detect and differentiate
between SARS-CoV-2 and influenza A/B, as the symptoms are similar for both
(FDA EUA and CE Mark)
- a second
SARS-CoV-2 antibody test, aimed at measuring the spike protein to support
vaccination development and complement our existing portfolio
- a
point-of-care molecular PCR test that simultaneously detects and
differentiates between SARS-CoV-2 and influenza A/B infections to support
urgent triage and diagnosis (FDA EUA and CE Mark)
Roche is committed to improving the treatment of COVID-19. We are actively involved in understanding the potential of our existing portfolio and are exploring the potential of our investigational molecules.
In August, we announced a partnership with Regeneron to develop, manufacture, and increase global supply of their investigational antibody combination for COVID-19 if it proves safe and effective in clinical trials and regulatory approvals are granted.
At the beginning of the pandemic, on 19 March, we announced the initiation of COVACTA - a global Phase III randomised, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous Actemra©/RoActemra© (tocilizumab) plus standard of care in hospitalised adult patients with severe COVID-19 pneumonia compared to placebo plus standard of care. On 29 July we announced that COVACTA did not meet its primary endpoint of improved clinical status in patients with COVID-19 associated pneumonia or the key secondary endpoint of reduced mortality.
Separately, we have studied Actemra©/RoActemra© in the EMPACTA study in COVID-19 associated hospitalised pneumonia in patients that are often underrepresented in clinical trials. On 18 September we announced that the phase III EMPACTA study showed Actemra/RoActemra plus standard of care reduced the likelihood of progression to mechanical ventilation or death in hospitalised patients with COVID-19 associated pneumonia compared to placebo plus standard of care. However, there was no statistical difference in mortality between patients who received Actemra/RoActemra or placebo.
Actemra©/RoActemra© is also being studied in combination with the investigational antiviral remdesivir in hospitalised patients with severe COVID-19 pneumonia in the REMDACTA trial in partnership with Gilead, announced 28 May. Actemra©/RoActemra© is not approved by any health authority for use in COVID-19 pneumonia. Roche has further initiated an internal early research programme focused on the development of medicines for COVID-19 and is engaged in multiple research collaborations.
In these exceptional times, Roche stands together with governments, healthcare providers and all those working to overcome the pandemic.
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