Janssen Reports Positive Top-line Phase 3 Study Results of Investigational, Long-acting Injectable HIV Treatment Regimen Administered Every Two Months
CORK, Ireland, Aug. 22, 2019 /PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) have announced positive top-line results from the Phase 3 ATLAS-2M study of the investigational, long-acting two-drug injectable regimen of its rilpivirine and ViiV Healthcare's cabotegravir for the treatment of HIV. The study achieved its primary objective, showing that administering the long-acting (LA) injectable regimen of Janssen's rilpivirine and ViiV's cabotegravir every two months was as effective in maintaining viral suppression throughout the 48-week study period as monthly dosing in adults living with HIV-1 infection, whose viral load is suppressed and not resistant to rilpivirine or cabotegravir.
Non-inferiority was measured by the proportion of participants with plasma HIV-RNA ? 50 copies per milliliter (c/mL) using the FDA Snapshot algorithm at Week 48 (Intent-to-Treat Exposed [ITTE] population). Overall safety, virologic response, and drug resistance results for the LA regimen were consistent with results from the Phase 3 ATLAS study1
The ATLAS-2M study is a Phase 3, randomized, open-label, active-controlled, multicenter, parallel-group, non-inferiority study designed to assess the antiviral activity and safety of the LA regimen administered every two months compared to the LA regimen administered monthly over a 48-week treatment period in 1,045 adults living with HIV-1. The study is being conducted at research centers in Australia, Argentina, Canada, France, Germany, Italy, Mexico, Russia, South Africa, South Korea, Spain, Sweden and the United States. For further information, please see https://clinicaltrials.gov/ct2/show/NCT03299049.
Detailed results from the ATLAS-2M study will be presented at an upcoming scientific meeting.
The LA regimen is being co-developed as a collaboration with ViiV Healthcare and has been submitted to regulatory authorities in the United States, Canada and Europe. A Priority Review Designation for the once-monthly injectable regimen was granted by the US FDA.
About rilpivirine long-acting
Rilpivirine long-acting is an investigational, prolonged-release suspension for intramuscular injection being developed by Janssen Sciences Ireland UC and is not approved by regulatory authorities anywhere in the world.
Cabotegravir is an investigational integrase inhibitor (INI) and is not approved by regulatory authorities anywhere in the world. Cabotegravir is being developed by ViiV Healthcare for the treatment and prevention of HIV and is currently being evaluated as a long-acting, prolonged-release formulation for intramuscular injection and also as a once-daily oral tablet for short-term use prior to long-acting injection.
About the Janssen Pharmaceutical Companies of Johnson & Johnson
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Notice to Investors Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding rilpivirine and development of potential preventive and treatment regimens for HIV. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Sciences Ireland UC, any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 30, 2018, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in the company's most recently filed Quarterly Report on Form 10-Q, and the company's subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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1CROI 2019. Long-acting cabotegravir + rilpivirine as maintenance therapy: ATLAS week 48 results. Available at: http://www.croiconference.org/sessions/long-acting-cabotegravir-rilpivirine-maintenance-therapy-atlas-week-48-results. Last accessed August 2019.
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