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Find Clinical Drug Pipeline Developments & Deals for DSSTox_CID_29808
Stride's Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Truvada Tablets, 200 mg/300 mg, of Gilead Sciences.
Following 90 days of dosing, ATI-2173, in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated with alanine aminotransferase (ALT) normalization and no ALT flares off-treatment.
JNJ-3989 is a sub-cutaneous, ribonucleic acid interference (RNAi) therapy candidate which is designed to silence all HBV gene products and intervenes upstream of the reverse transcription process where current standard-of-care nucleotide and nucleoside analogues act.
The data showed that ATI-2173 alone, or in combination with tenofovir disoproxil fumarate (TDF), was generally well-tolerated among the cohorts, and ATI-2173 and TDF suppressed HBV DNA and induced declines in biomarkers of cccDNA activity.
The proceeds from this financing will be used to advance the clinical development of ATI-2173, Antios’ lead Phase 2b clinical candidate. ATI-2173 is the only Active Site Polymerase Inhibitor Nucleotide (ASPIN) in clinical development.
The NDA was based on the results from two phase IIb/III studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in men who have sex with men, transgender women, and cisgender women use in HIV prevention.
The multi-center, double-blinded, placebo-controlled, multiple-dose cohort will evaluate the safety, pharmacokinetics, immunogenicity, and antiviral activity of the combination of ATI-2173, AB-729 and Viread.
Lupin has received tentative approval from the United States FDA under the U.S. President’s Emergency Plan for AIDS Relief for its NDA for Dolutegravir, Lamivudine & Tenofovir Disoproxil Fumarate Tablets, 50 mg/300 mg/300 mg, and antiretroviral Fixed Dose Combination.
Lupin has received approval from the United States Food and Drug Administration (USFDA) to market its Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 200 mg/300 mg. The drugs are indicated in combination with other antiretroviral agents for HIV-1 infection.
The breakthrough therapy designation is based on efficacy and safety results from HPTN 083, a phase IIb/III clinical trial that compared long-acting, injectable cabotegravir to daily oral emtricitabine/tenofovir disoproxil fumarate 200 mg and 300 mg for HIV prevention.
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