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Atea Pharmaceuticals Introduces New Strategic Clinical Development Program for AT-527 in COVID-19

Atea Pharmaceuticals Introduces New Strategic Clinical Development Program for AT-527 in COVID-19


Responding to the speedily evolving SARS-CoV-2, rising variants and transforming procedure landscape, Atea is updating the growth technique for AT-527

In addition to monotherapy analysis, expanding advancement plan to optimize AT-527’s profile for prospective use in blend therapy to meet up with the latest and upcoming demands of COVID-19 as it transitions to endemic

AT-527’s differentiated system of action with dual targets, which includes chain termination (RdRp) and NiRAN inhibition, could perhaps present a high barrier to resistance with broad antiviral coverage to coronaviruses and variants producing its profile nicely suited for monotherapy and blend use

Initiating preclinical in vitro blend reports of AT-527 and other compounds with distinct mechanisms of action to examine additive and synergistic added benefits

BOSTON, Dec. 14, 2021 (World NEWSWIRE) — Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-phase biopharmaceutical corporation, right now introduced an up-to-date technique for AT-527 to address the swiftly evolving SARS-CoV-2 and rising variants by maximizing the compound’s unique profile for potential use as both equally a monotherapy and in mix. Having into account the changing COVID-19 landscape with the anticipated availability of new antiviral remedy regimens, the world wide Phase 3 MORNINGSKY trial will be closed out and the ongoing Stage 2 hospitalized trial will be further amended to broaden enrollment to unvaccinated, significant-risk outpatients. Atea expects to deliver a more detailed update on its strategy and new progress plan in 2022.

“We imagine strongly in AT-527’s possible to fight the evolving SARS-CoV-2 and rising variants as a monotherapy and as an vital spine in probable blend therapy,” mentioned Jean-Pierre Sommadossi, PhD, Main Government Officer and Founder of Atea Pharmaceuticals. “Our new system enables us to quickly travel forward a approach to optimize AT-527’s distinctive profile with a growth tactic designed to meet the present and potential desires of COVID-19, which may well include things like the emergence of new variants and drug resistance to other therapies.”

“The nucleoside class has been the cornerstone of powerful oral antiviral combination treatment options for extreme viral diseases, and we are making ready for a upcoming exactly where combination regimens may well be required to deal with COVID-19 as the virus and pandemic evolve. Importantly, we have the financial and internal assets to execute this strategy by way of key clinical and regulatory inflection factors,” extra Dr. Sommadossi.

“After very careful thought of the fast evolution of SARS-CoV-2 and the emergence of variants mixed with the increasing availability of new COVID-19 cure choices, which include the anticipated new antiviral regimens, continuing the MORNINGSKY demo is not the most efficient route ahead,” reported Janet Hammond, MD, PhD, Main Progress Officer of Atea Prescribed drugs. “Our new development strategy will leverage AT-527’s one of a kind profile with the objective to progress an oral, most effective-in-class, drug candidate that can be utilized broadly for the cure of coronaviruses and for long term pandemic preparedness.”

Atea will carry on to advance the global AT-527 Period 2 trial evaluating the basic safety, tolerability and virological activity of AT-527 in unvaccinated sufferers with risk aspects with moderate COVID-19. This ongoing analyze is at this time checking out doses up to 1,100 mg BID in sufferers who are managed in a hospitalized or confined setting. Atea intends to even further amend this examine to remove the need for affected person confinement or hospitalization. The amended Phase 2 demo is expected to enroll up to 200 individuals. Atea anticipates reporting details from this trial all through 2022. In addition, Atea is initiating preclinical in vitro mixture studies of AT-527 and other compounds with distinct mechanisms of action to evaluate additive and synergistic rewards.

In addition to MORNINGSKY, the adhere to-on MEADOWSPRING trial will also be shut out. The strategic collaboration with Roche will be terminated on February 10, 2022.

About the AT-527 COVID-19 Medical Improvement Method

Derived from Atea’s nucleos(t)ide prodrug platform, AT-527 is an oral direct-acting antiviral which is becoming analyzed to figure out its prospective to guard towards illness development and the enhancement of very long-COVID difficulties. Its distinctive system of motion, with dual targets like chain termination (RdRp) and NiRAN inhibition, has the potential to develop a substantial barrier to resistance with broad antiviral coverage to distinctive variants of SARS-CoV-2. Atea has concluded a detailed nonclinical program to characterize the protection profile of AT-527. Final results observed from these nonclinical studies demonstrated that AT-527 was non-mutagenic, experienced no outcomes on fertility or reproduction and was non-teratogenic.

About Atea Pharmaceuticals

Atea Prescription drugs is a scientific phase biopharmaceutical firm centered on finding, establishing and commercializing oral therapies to tackle the unmet clinical wants of people with existence-threatening viral disorders. Leveraging the Company’s deep comprehending of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has designed a proprietary nucleotide prodrug system to build novel products candidates to handle single stranded ribonucleic acid, or ssRNA, viruses, which are a widespread bring about of severe viral illnesses. Presently, Atea is targeted on the progress of orally-accessible, powerful, and selective nucleotide prodrugs for hard-to-treat, daily life-threatening viral infections, including critical acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that will cause COVID-19, dengue virus, hepatitis C virus (HCV) and respiratory syncytial virus (RSV). For far more details, you should pay a visit to www.ateapharma.com.

Forward-Seeking Statements

This push release includes forward-on the lookout statements in the this means of the Personal Securities Litigation Reform Act of 1995. All statements contained in this press launch that do not relate to matters of historic truth must be deemed forward-looking statements, like without limitation statements with regards to our expectations bordering the likely of our item candidates, which include AT-527 and AT-752, and anticipations concerning our pipeline, together with demo layout and enhancement timelines. These statements are neither guarantees nor ensures, but involve acknowledged and not known pitfalls, uncertainties and other essential variables that could induce our real effects, overall performance or achievements to be materially distinct from any long term benefits, efficiency or achievements expressed or implied by the forward-looking statements, which include, but not confined to, the adhering to: uncertainty all around and charges linked with the advancement of AT-527 as a potential remedy for COVID-19 and our other item candidates dependence on management, administrators and other vital personnel the effect of the COVID-19 pandemic on our organization our confined running record and significant losses given that inception our want for sizeable supplemental funding our capacity to use our web running decline carryforwards our dependence on the achievements of our most superior solution candidates hazards similar to the regulatory approval course of action threats affiliated with the clinical advancement course of action and reliance on interim or topline scientific trial final results challenges linked to healthcare laws and other lawful compliance issues challenges connected to potential commercialization threats connected to producing and our dependence on third get-togethers challenges relating to mental residence our ability to retain effective inner management around economical reporting and the significant prices as a end result of working as a general public business. These and other significant aspects reviewed under the caption “Risk Factors” in our most modern Quarterly Report on Kind 10-Q, and our other filings with the SEC could bring about actual benefits to differ materially from individuals indicated by the ahead-wanting statements created in this press release. Any this sort of forward-on the lookout statements signify management’s estimates as of the date of this push launch. Though we may well elect to update this sort of ahead-on the lookout statements at some point in the long run, we disclaim any obligation to do so, even if subsequent functions result in our sights to adjust.

Contacts

Jonae Barnes
SVP, Trader Relations and Corporate Communications
617-818-2985
[email protected]

Will O’Connor
Stern Trader Relations
212-362-1200
[email protected]



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