Advancing Bemnifosbuvir to
New Data Demonstrate Bemnifosbuvir Retained Antiviral Activity Against Omicron Subvariant In Vitro
Progressing Internal Second-Generation Protease Inhibitor Discovery Program for COVID-19 Combination Therapy; New Data Indicate Additive Antiviral Effect with Bemnifosbuvir in Combination with Nirmatrelvir (Protease Inhibitor) In Vitro
Enrolling AT-752 Global Phase 2 Trial and
Preparing for Initiation of Phase 2 Combination Trial of Bemnifosbuvir and Ruzasvir for Hepatitis C (HCV)
Conference Call at
“COVID-19 continues to be a global emergency with waning efficacy from vaccines, therapeutics and prior infections driving an unmet medical need. New antivirals with improved profiles are urgently needed,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of
“For dengue, we are currently enrolling two proof-of-concept trials for AT-752 and expect initial results in late 2022. Dengue is the most prevalent mosquito-borne virus with no approved antiviral therapies, and it is a substantial public health and economic burden. Additionally, for HCV we are preparing for the initiation of a Phase 2 combination study of bemnifosbuvir and ruzasvir, which is expected in late 2022. The target profile of our HCV combination includes convenient and short duration treatment with the potential for the first ribavirin-free therapy for decompensated disease,” continued Dr. Sommadossi. “Importantly, we remain well capitalized to advance our programs, which we expect will deliver a number of important milestones over the next 18 months.”
Bemnifosbuvir (AT-527) Program Update for COVID-19
Bemnifosbuvir to Advance to
Topline Efficacy Results from Phase 3 MORNINGSKY Trial: In May, Atea reported a topline analysis of data from the MORNINGSKY trial in which the primary endpoint, time to symptom alleviation, was not achieved. However, a 71% reduction in hospitalization (2.9% versus 10%) was observed (p=0.047, unadjusted, exploratory) in the bemnifosbuvir arm (n=137) versus placebo (n=70). There were no deaths in the trial. Hospitalization and death are study endpoints that are currently preferred by the FDA and other regulatory authorities.
MORNINGSKY was a randomized, double-blind, multi-center, placebo-controlled Phase 3 trial evaluating the efficacy, safety, antiviral activity, and pharmacokinetics of bemnifosbuvir, which intended to enroll up to 1,400 patients randomized 2:1 to receive bemnifosbuvir 550 mg BID or placebo in an outpatient setting. Consistent with previous studies, bemnifosbuvir 550 mg BID was generally safe and well tolerated with no drug-related serious adverse events. The study was closed out early in
Data from Final Analysis of Phase 2 Hospitalized Study in High-Risk Patients: In May, Atea reported final clinical results from the Phase 2 hospitalized study in high-risk patients (n=83) and results suggest potential clinical benefits. The global Phase 2 trial was a randomized, double-blind, placebo-controlled, multi-center study to evaluate bemnifosbuvir in patients with moderate COVID-19 in the hospital setting. There were 3 deaths in the study, no deaths were reported in patients treated with bemnifosbuvir versus 3 deaths reported with placebo. Final virology results (secondary endpoint) were consistent with previously reported interim data from this study. Bemnifosbuvir was generally safe and well tolerated with no drug-related serious adverse events.
New: Bemnifosbuvir Retains Antiviral Activity Against Omicron Subvariant In Vitro: AT-511, the free base of bemnifosbuvir, has been shown to be a potent inhibitor of SARS-CoV-2 in vitro. New results demonstrated that AT-511 retained potent antiviral activity against the SARS-CoV-2 variant Omicron BA.2. AT-511 has previously demonstrated in vitro potent antiviral activity against variants of concern and/or of interest, including Alpha, Beta, Gamma, Epsilon, Delta and Omicron BA.1.
Advancing a Multipronged Approach for COVID-19 Future Preparedness
New: Additive Antiviral Effect Demonstrated with Bemnifosbuvir in Combination with Protease Inhibitor In Vitro in a Surrogate Virus Model: The combination of bemnifosbuvir with the protease inhibitor nirmatrelvir was examined in vitro in an HCoV-229E surrogate model and results indicate an additive antiviral effect. These data support the potential benefit of the combination of bemnifosbuvir and a protease inhibitor for the treatment of SARS-CoV-2 infection.
AT-752 Program Update for Dengue
Enrolling Global Phase 2 Dengue Study and Human Challenge Trial: Patient enrollment continues for the global Phase 2 DEFEND-2 (DEngue Fever END) study of AT-752 for the treatment of dengue. The randomized, double-blind, placebo-controlled study is evaluating multiple doses of AT-752 and is expected to enroll up to 60 adult patients infected with dengue. The primary objective of the study is to assess antiviral activity, with change from baseline in dengue virus (DENV) viral load as the primary endpoint [DENV RNA by reverse transcription-polymerase chain reaction (RT-PCR)].
In addition to the DEFEND-2 study, Atea is enrolling a dengue human challenge trial. This trial, which is being conducted exclusively in
Results from the human challenge trial and initial results from the DEFEND-2 study are expected in the fourth quarter of 2022.
Hepatitis C Virus (HCV) Program Update
Phase 2 HCV Combination Program: Atea has completed a required combination preclinical toxicology study and is currently manufacturing ruzasvir (RZR) clinical trial supplies. Also, Atea is finalizing a clinical trial design for the Phase 2 combination study of bemnifosbuvir and RZR, which is expected to be initiated in late 2022. Studies conducted by Atea have shown in vitro synergy from the combination of bemnifosbuvir and RZR in inhibiting HCV replication. In
Second Quarter 2022 Financial Results
Cash and Cash Equivalents: $684.5 million at
Research and Development Expenses: Research and development expenses for the quarter ended
General and Administrative Expenses: General and administrative expenses for the quarter ended
Interest Income and Other, Net: Interest income and other, net increased by
Income Tax Expense: Income tax expense decreased by
Net Income (Loss): Net loss for the quarter ended
Condensed Consolidated Statement of Operations and Comprehensive Income (Loss) (in thousands, except share and per share amounts) (unaudited) | |||||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Collaboration revenue | $ | — | $ | 60,391 | $ | — | $ | 126,376 | |||||||
Operating expenses | |||||||||||||||
Research and development | 19,858 | 39,803 | 49,491 | 66,375 | |||||||||||
General and administrative | 12,437 | 11,901 | 24,979 | 20,658 | |||||||||||
Total operating expenses | 32,295 | 51,704 | 74,470 | 87,033 | |||||||||||
Income (loss) from operations | (32,295 | ) | 8,687 | (74,470 | ) | 39,343 | |||||||||
Interest income and other, net | 1,080 | 52 | 1,178 | 109 | |||||||||||
Income (loss) before income taxes | (31,215 | ) | 8,739 | (73,292 | ) | 39,452 | |||||||||
Income tax expense | (120 | ) | (7,200 | ) | (120 | ) | (7,200 | ) | |||||||
Net income (loss) and comprehensive income (loss) | $ | (31,335 | ) | $ | 1,539 | $ | (73,412 | ) | $ | 32,252 | |||||
Net income (loss) per share attributable to common stockholders | |||||||||||||||
Basic | $ | (0.38 | ) | $ | 0.02 | $ | (0.88 | ) | $ | 0.39 | |||||
Diluted | $ | (0.38 | ) | $ | 0.02 | $ | (0.88 | ) | $ | 0.36 | |||||
Weighted-average common shares outstanding | |||||||||||||||
Basic | 83,257,591 | 82,743,530 | 83,217,223 | 82,662,019 | |||||||||||
Diluted | 83,257,591 | 88,091,384 | 83,217,223 | 88,683,767 |
Selected Condensed Consolidated Balance Sheet Data (in thousands) (unaudited) | |||||
Cash and cash equivalents | $ | 684,480 | $ | 764,375 | |
Working capital(1) | 664,344 | 715,520 | |||
Total assets | 694,338 | 772,892 | |||
Total liabilities | 33,881 | 62,815 | |||
Total stockholders' equity | 660,457 | 710,077 |
(1) The Company defines working capital as current assets less current liabilities. See the Company’s condensed consolidated financial statements in its Quarterly Report on Form 10-Q for the three months ended
Conference Call and Webcast
Atea will host a conference call and live audio webcast to discuss second quarter 2022 financial results and provide a corporate update today at
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, 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. 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
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