depulfavirine (VM-1500A-LAI) / Viriom - LARVOL DELTA

Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Viriom | Recruiting ➔ Completed

Trial completion • Human Immunodeficiency Virus • Infectious Disease

Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects (clinicaltrials.gov) - P1 | N=24 | Recruiting | Sponsor: Viriom | Not yet recruiting ➔ Recruiting | Trial completion date: Mar 2022 ➔ Jun 2022

Enrollment open • Trial completion date • Human Immunodeficiency Virus • Infectious Disease

Study to Evaluate Efficacy and Safety of Switching to VM-1500A-LAI + 2NRTIs From the 1st Line Standard of Care Therapy (clinicaltrials.gov) - P2/3; N=438; Not yet recruiting; Sponsor: Viriom

New P2/3 trial • Human Immunodeficiency Virus • Infectious Disease • CD4

Study of Single Ascending Doses of Elsulfavirine to Evaluate the Safety, Tolerability, and Pharmacokinetics of Elsulfavirine and Its Active Metabolite VM-1500A in Healthy Subjects (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Viriom

Clinical • New P1 trial • Human Immunodeficiency Virus • Infectious Disease

Open Labelled, Randomized Study to Evaluate the Efficacy, Safety and Dose Selection of VM-1500A-LAI Drug in HIV-infected Patients Transferred From Previous Stable Therapy (NNRTI + 2NRTI), Including ELPIDA® (clinicaltrials.gov) - P1/2; N=36; Completed; Sponsor: Viriom

Clinical • New P1/2 trial • Human Immunodeficiency Virus • Infectious Disease

Study to Evaluate Safety, Tolerability and Pharmacokinetics of VM-1500A-LAI Single and Multiple Ascending Doses in Healthy Subjects (clinicaltrials.gov) - P1; N=27; Completed; Sponsor: Viriom; Not yet recruiting ➔ Completed; N=42 ➔ 27

Clinical • Enrollment change • Trial completion • Human Immunodeficiency Virus • Infectious Disease

Biochemical profiling of anti-HIV prodrug Elsulfavirine (Elpida) and its active form VM1500A against a panel of twelve human carbonic anhydrase isoforms. (PubMed, J Enzyme Inhib Med Chem) - "Biochemical profiling against twelve human carbonic anhydrase (CA, EC 4.2.1.1) isoforms showed that while elsulfavirine was a weak inhibitor of all isoforms, VM1500A potently and selectively inhibited human (h) hCA VII isoform, a proven target for the therapy of neuropathic pain. The latter is a common neurologic complication of HIV infection and we hypothesise that by using Elpida in patients may help alleviate this debilitating symptom."

Journal • Human Immunodeficiency Virus • Infectious Disease • Neuralgia • Pain • Peripheral Neuropathic Pain

Elpida (elsulfavirine) becomes the preferred first line therapy for treatment of HIV infection in Russia (PRNewswire) - "Viriom Inc...announces that its antiviral drug Elpida®(elsulfavirine) has been included in the preferred first-line antiretroviral therapy (ART) regimens by the Ministry of Health of the Russian Federation according to updated clinical guidelines for the treatment of HIV infection in adults and children. Regimens for adults include the combination of elsulfavirine + lamivudine (or emtricitabine) + tenofovir. Viriom has filed for the market authorization of the fixed dose combination of elsulfavirine + tenofovir and emtricitabine in Russia and the Eurasian Economic Union....Viriom is conducting a broad development program to evaluate the potential of elsulfavirine/VM1500A for the treatment and prevention of HIV-1 infection."

Clinical guideline • Non-US regulatory • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] Multicenter, open‐label, post‐authorization safety study (PASS) of elsulfavirine (Elpida®) used in the first‐line therapy for HIV‐1 infected patients added to standard ART (NNRTI + two NRTIs) (HIV-Glasgow 2020) - "Background: VM1500A is a novel, potent non-nucleoside reverse transcriptase inhibitor with a unique clinical pharmacokinetic profile and broad-spectrum activity across HIV-1 variants. The interim analysis of the study supports the previous safety and efficacy data for Elpida and encourages further treatment. The preliminary efficacy data shows a consistently high full viral suppression rate in patients with significant immunological efficacy. The safety and tolerability profile allows for high adherence and long-term treatment with ESV 20 mg as part of ART."

Clinical • Human Immunodeficiency Virus • Infectious Disease

[VIRTUAL] SAFETY AND PK STUDY OF VM-1500A-LAI, A NOVEL LONG-ACTING INJECTABLE THERAPY FOR HIV (CROI 2020) - "VM-1500A-LAI IM qm of 1200 mg achieved median plasma Ctrough above target for 35 days and above. VM1500A LAI was tolerated and had an acceptable PK profile in healthy volunteers following single IM dosing in a range of 150mg to 1200mg."

Clinical • Late-breaking abstract