Safety and pharmacokinetic data in healthy volunteers support ongoing clinical development
AT-752 is a novel, orally administered, direct-acting antiviral in Phase 2 development with a Fast Track designation from the
Dengue is endemic in more than 100 countries putting greater than half the world’s population at-risk for this mosquito-borne viral disease
The poster #1358, titled “Safety, tolerability, and pharmacokinetics of AT-752, a novel nucleotide prodrug with pan-serotype activity against dengue virus: results from a Phase 1, first-in-human, dose-escalation study,” was presented by
“Dengue is the most prevalent mosquito-borne virus and despite its alarming increase over the last two decades, there are no direct-acting antiviral treatments available,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of
“Importantly, these results support our advancement of two proof-of-concept studies to demonstrate AT-752’s safety and efficacy for the treatment and potential prophylaxis of dengue,” continued Dr. Sommadossi.
Atea is currently conducting two AT-752 clinical studies. The first study is a global, randomized, double-blind, placebo-controlled Phase 2 trial in adult patients with dengue virus infection. The study is designed to evaluate the antiviral activity, safety and pharmacokinetics (PK) of multiple doses of AT-752 in areas where dengue is endemic. The second study is a human challenge study that is being conducted in
AT-752, a novel, orally administered direct-acting antiviral derived from Atea’s purine nucleotide prodrug platform was designed for the treatment and prophylaxis of dengue. It works by impairing the dengue viral polymerase, which then inhibits replication of the virus. In preclinical studies, AT-752 showed potent in vitro activity against all dengue serotypes, as well as potent in vivo antiviral activity in a small animal model.
The
AT-752 Phase 1 Study Results
In the Phase 1 study, 65 healthy subjects aged 18–65 years old were sequentially enrolled into single ascending dose (SAD) and multiple ascending dose (MAD) cohorts and randomized to receive oral AT-752 or placebo. AT-752 was administered as a single oral dose up to 1500 mg, or as multiple oral doses up to 750 mg three times a day. In this study, AT-752 rapidly achieved plasma levels exceeding the in vitro EC90. AT-752 was generally safe and well tolerated and no premature discontinuations due to adverse events or serious adverse events were reported. Most adverse events were mild and there were no clinically relevant changes in laboratory parameters. AT-752 exhibited no PK sensitivity across varying ethnic populations participating in the trial and no food effect was seen.
The overall safety and PK results obtained in this Phase 1 study supported the initiation of two clinical studies of AT-752 for the treatment and prophylaxis of dengue infection.
About Dengue Fever
It is estimated that dengue accounts for up to 400 million infections a year globally, of which 100 million people get sick from the infection and 500,000 cases develop into life-threatening dengue hemorrhagic fever. Dengue infection is currently endemic in equatorial regions of the world, including
Four serotypes of dengue viruses (DENV1–4) are common and a fifth serotype has been isolated but is yet to be fully characterized. As dengue serotypes are sufficiently different antigenically, infection with one serotype will confer lifelong immune protection against that serotype only, with only temporary, partial cross-immunity to other serotypes following recovery. A person can therefore potentially be infected with each dengue serotype in their lifetime. Subsequent infections with other serotypes increase the risk of developing severe disease due to antibody-dependent enhancement (ADE).
The
About
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding our expectations surrounding the potential of our product candidates, including bemnifosbuvir combination product candidates, and expectations regarding our pipeline, including trial design and development timelines. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the uncertainty around and costs associated with the clinical development of bemnifosbuvir as a potential treatment for COVID-19 and HCV and the clinical development AT-752 for the potential treatment and prevention of dengue. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ended
Contacts
SVP, Investor Relations and Corporate Communications
617-818-2985
Barnes.jonae@ateapharma.com
Will O’Connor
Stern Investor Relations
212-362-1200
will.oconnor@sternir.com
Source:
2022 GlobeNewswire, Inc., source