A Single Dose Oral Bioavailability Study of PanCytoVir™ Oral Suspension (100 mg/ml) 1000 mg Versus Probenecid 500 mg Tablets, 1000 mg (2 X 500 mg) in Healthy, Adult, Human Subjects Under Fasting Conditions

An open-label, balanced, randomized, two-treatment, two-sequence, two-period, crossover, single dose oral relative bioavailability study of a novel PanCytoVir™ oral suspension (100 mg/mL) versus probenecid 500 mg tablets in normal healthy, adult, human subjects under fasting conditions.

开始日期2024-06-01

申办/合作机构

TrippBio, Inc.

NCT06025318 / Not yet recruiting临床1期

An Open-label, Balanced, Randomized, Two-period, Crossover, Single Dose Study to Compare the Bioavailability of PanCytoVir™ Oral Suspension (100mg/ml), in Healthy, Adult, Human Subjects Under Fed and Fasting Conditions

This is an open-label, balanced, randomized, two-period, crossover, single dose study to compare the relative bioavailability in normal healthy, adult, human subjects under Fed and Fasting conditions. Subjects will receive a single oral dose of probenecid oral suspension (100 mg/mL) under fed and fasted conditions.

开始日期2024-06-01

申办/合作机构

TrippBio, Inc.

NCT05442983 / Completed临床2期

A Randomized, Single-center, Single-blind, Placebo-controlled Study to Evaluate the Efficacy of PanCytoVir™ 500 mg Twice Daily and 1000 mg Twice Daily for the Treatment of Non-hospitalized Patients With COVID-19 Infection

This is a randomized, single-center, single-blind, placebo controlled, study to evaluate efficacy of PanCytoVir™ 500 mg twice daily and 1000 mg twice daily for the treatment of non-hospitalized patients with COVID-19 infection.

开始日期2022-07-12

申办/合作机构

TrippBio, Inc.

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项与 TrippBio, Inc. 相关的文献（医药）

2023-07-06·Viruses

Oral Probenecid for Nonhospitalized Adults with Symptomatic Mild-to-Moderate COVID-19.

Article

作者: Sutariya, Rakesh ; Martin, David E ; Tripp, Ralph A ; Chavda, Purvi ; Pandey, Neelam ; Sancilio, Frederic ; Singh, Gurpreet

Probenecid is an orally bioavailable, uricosuric agent that was first approved in 1951 for the treatment of gout, but was later found to have potent, broad-spectrum antiviral activity against several respiratory viruses including SARS-CoV-2. We conducted a phase 2 randomized, placebo-controlled, single-blind, dose-range finding study in non-hospitalized patients with symptomatic, mild-to-moderate COVID-19. Patients were randomly assigned in a 1:1:1 ratio to receive either 500 mg of probenecid, 1000 mg of probenecid, or a matching placebo every 12 h for five days. The patients' COVID-19 viral load hospitalization, or death from any cause through day 28, as well as safety, were evaluated. COVID-19-related symptoms were assessed at baseline, and on days 3, 5, 10, 15, and 28. The primary endpoints of the study were time to first negative SARS-CoV-2 viral test (or viral clearance) and the proportion of patients that were symptom-free at day 5. A total of 75 patients were randomized, with 25 patients in each group. All of the patients completed the study as planned with no hospitalizations or deaths being reported. The median time to viral clearance was significantly shorter for the probenecid 1000 mg group than for placebo (7 days vs. 11 days, respectively; p < 0.0001), and for the probenecid 500 mg group versus placebo (9 days vs. 11 days, respectively; p < 0.0001). In addition, the median time to viral clearance was significantly shorter for the probenecid 1000 mg group than for the probenecid 500 mg group (7 days vs. 9 days, respectively; p < 0.0001). All patients reported at least one COVID-19-related symptom on days 3 and 5; however, on day 10, a significantly greater proportion of patients receiving probenecid 1000 mg reported the complete resolution of symptoms versus placebo (68% vs. 20%, respectively; p = 0.0006), as well as for those receiving probenecid 500 mg versus placebo (56% vs. 20%, respectively, p = 0.0087). The incidence of adverse events during treatment was similar across all groups for any adverse event, and was 12%. All events were mild with no serious adverse events reported and no discontinuations due to an adverse event. The treatment of patients with symptomatic, mild-to-moderate COVID-19 with probenecid resulted in a significant, dose-dependent decrease in the time to viral clearance and a significantly higher proportion of patients reporting complete symptom resolution by day 10. (Supported by TrippBio; ClinicalTrials.gov number, NCT05442983 and Clinical Trials Registry India number CTRI/2022/07/043726).

Scientific Reports

Probenecid inhibits SARS-CoV-2 replication in vivo and in vitro

Article

作者: Tripp, Ralph A ; Hogan, Robert J ; Balyan, Rajiv ; Martin, David E ; Blahunka, Kathy ; Sancilio, Fred D ; Lovern, Mark ; Murray, Jackelyn ; Still, Richard

AbstractEffective vaccines are slowing the COVID-19 pandemic, but SARS-CoV-2 will likely remain an issue in the future making it important to have therapeutics to treat patients. There are few options for treating patients with COVID-19. We show probenecid potently blocks SARS-CoV-2 replication in mammalian cells and virus replication in a hamster model. Furthermore, we demonstrate that plasma concentrations up to 50-fold higher than the protein binding adjusted IC90 value are achievable for 24 h following a single oral dose. These data support the potential clinical utility of probenecid to control SARS-CoV-2 infection in humans.

Viruses3区 · 医学

Repurposing Probenecid to Inhibit SARS-CoV-2, Influenza Virus, and Respiratory Syncytial Virus (RSV) Replication

3区 · 医学

ReviewOA

作者: Tripp, Ralph A ; Martin, David E

Viral replication and transmissibility are the principal causes of endemic and pandemic disease threats. There remains a need for broad-spectrum antiviral agents. The most common respiratory viruses are endemic agents such as coronaviruses, respiratory syncytial viruses, and influenza viruses. Although vaccines are available for SARS-CoV-2 and some influenza viruses, there is a paucity of effective antiviral drugs, while for RSV there is no vaccine available, and therapeutic treatments are very limited. We have previously shown that probenecid is safe and effective in limiting influenza A virus replication and SARS-CoV-2 replication, along with strong evidence showing inhibition of RSV replication in vitro and in vivo. This review article will describe the antiviral activity profile of probenecid against these three viruses.

项与 TrippBio, Inc. 相关的新闻（医药）

2023-08-01

·drugs

Oral Probenecid Cuts Time to Viral Clearance in COVID-19

TUESDAY, Aug. 1, 2023 -- For patients with symptomatic, mild-to-moderate COVID-19, oral probenecid results in a reduction in the time to viral clearance, according to a study published online July 6 in Viruses . David E. Martin, Pharm.D., from TrippBio Inc. in Jacksonville, Florida, and colleagues conducted a phase 2 randomized, dose range-finding trial in nonhospitalized patients with symptomatic, mild-to-moderate COVID-19. Patients were randomly assigned to 500 mg probenecid, 1,000 mg probenecid, or placebo every 12 hours for five days (25 patients in each group). The researchers found that the median time to viral clearance was significantly shorter for probenecid 1,000 mg and for probenecid 500 mg versus placebo (seven and nine days, respectively, versus 11 days). Furthermore, the median time to viral clearance was significantly shorter for probenecid 1,000 versus 500 mg (seven versus nine days). On days 3 and 5, all patients reported at least one COVID-19-related symptom; however, on day 10, complete resolution of symptoms was reported by a significantly greater proportion of patients receiving probenecid 1,000 mg and probenecid 500 mg versus placebo (68 and 56 percent, respectively, versus 20 percent). The incidence of adverse events during treatment was 12 percent and was similar across all groups; all events were mild, with no reports of serious events or discontinuation due to an adverse event. "Based on these results, probenecid 1,000 mg b.i.d. for five days will be further evaluated to characterize its efficacy in patients with COVID-19," the authors write. Several authors disclosed ties to TrippBio, which funded the study; one author is employed by Zenovel Pharma Services; one author is an inventor on a granted patent application covering the method of use of probenecid as a treatment for coronavirus infections. Abstract/Full Text (subscription or payment may be required) Posted August 2023 Further Support and Information on COVID-19 COVID-19: Prevention & Investigational Treatments COVID-19 Support Group Coronavirus Disease Guide

临床2期临床结果

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