ABI-1179 for Genital Herpes

Not currently recruiting at 18 trial locations

Overseen By Assembly Biosciences Assembly Biosciences

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Assembly Biosciences

Disqualifiers: HIV, Hepatitis B, Hepatitis C, others

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment, ABI-1179 (a potential antiviral drug), for individuals with recurrent genital herpes caused by Herpes Simplex Virus Type 2 (HSV-2). Part A of the study assesses the drug's safety and tolerability in healthy participants and examines the impact of food on the drug's performance. Part B focuses on individuals with recurrent genital herpes to evaluate the effects of multiple doses. Those who are generally healthy but experience frequent genital herpes outbreaks may qualify for this trial. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that ABI-1179 is likely to be safe for humans?

Research has shown that ABI-1179 was well-tolerated in earlier studies, with participants not experiencing serious side effects. These studies involved individuals with recurring genital herpes, and the safety results appear promising. Although this trial remains in the early stages, current information suggests that ABI-1179 is safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for genital herpes?

ABI-1179 is unique because it offers a potentially new approach to treating genital herpes. While current treatments, like acyclovir and valacyclovir, primarily focus on suppressing the herpes virus and reducing outbreak frequency, ABI-1179 may work differently. Researchers are interested in its novel mechanism of action that could target the virus in a new way, potentially improving effectiveness and reducing the frequency of dosing. This could mean less frequent medication and possibly fewer side effects, making it a promising option for patients seeking more convenient and effective management of their condition.

What evidence suggests that ABI-1179 might be an effective treatment for genital herpes?

Research has shown that ABI-1179, which participants in this trial may receive, could help treat genital herpes. Studies have found a 94% decrease in the release of the HSV-2 virus from the body, meaning less virus spreads. Another study showed a 98% drop in cases with a high virus amount, indicating the treatment effectively reduces the virus level. These results are statistically significant, meaning they are unlikely due to chance. Patients also tolerated ABI-1179 well, suggesting it could be a safe option for managing genital herpes. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI between 18.0 and 32.0 kg/m2, who are not pregnant, agree to use contraception, and have no health issues apart from HSV-2 causing recurrent genital herpes.

Inclusion Criteria

I am eligible for both parts A and B of the study.

My BMI is between 18 and 32.

I agree to follow the study's birth control requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Single ascending dose (SAD) of ABI-1179 in healthy participants, including evaluation of food effect

1 week

1 visit (in-person)

Treatment Part B

Multiple ascending doses (MAD) of ABI-1179 in participants seropositive for HSV-2 with recurrent genital herpes

4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABI-1179

Trial Overview The study tests ABI-1179's safety, how the body processes it (pharmacokinetics), and its tolerability in two parts: one with single doses in healthy people and another with multiple doses in those with HSV-2 related recurrent genital herpes.

How Is the Trial Designed?

Group I: Part B: MAD Cohorts 1-4, ABI-1179 Experimental Treatment 2 Interventions

Weekly dose ofABI-1179 (tablet) in Part B for Cohorts 1-4. May have loading dose.

Group II: Part A: SAD Cohorts 1-5, ABI-1179 Experimental Treatment 2 Interventions

Single dose of ABI-1179 (tablet) in Part A for cohorts 1-5

Group III: Part A: (SAD) Fed Cohort 6 or 7, ABI-1179 Experimental Treatment 2 Interventions

Single dose of ABI-1179 (tablet) in Part A for Cohort 6 or 7, food effect

Group IV: Part A:SAD Cohorts 1-5, Placebo Placebo Group 2 Interventions

Single dose of matching placebo (tablet) in Part A for Cohorts 1-5

Group V: Part B: MAD Cohorts 1-4 Placebo Placebo Group 2 Interventions

Weekly dose of matching placebo (tablet) in Part B for Cohorts 1-4.

Who Is Running the Clinical Trial?

Assembly Biosciences

Lead Sponsor

Trials

21

Recruited

1,300+

Citations

1. investor.assemblybio.com investor.assemblybio.com/news-releases/news-release-details/assembly-biosciences-reports-positive-interim-results-phase-1b

Assembly Biosciences Reports Positive Interim Results ... 94% reduction in HSV-2 shedding rate and 98% reduction in high viral load shedding rate, both statistically significant, observed in cohort ...

2. clinicaltrialsarena.com clinicaltrialsarena.com/news/assembly-bio-herpes-drug-94-viral-shedding/

Assembly Bio's herpes drug shows 94% drop in viral ... Assembly Biosciences is advancing its herpes drug to Phase II trials after it showed 94% antiviral efficacy in a Phase Ib trial.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06698575

NCT06698575 | A Study to Assess the Safety, ... A Study to Assess the Safety, Pharmacokinetics, and Tolerability of ABI-1179 in Healthy Subjects and in Subjects Seropositive for HSV-2 With Recurrent Genital ...

4. firstwordpharma.com firstwordpharma.com/story/5936832

Assembly Biosciences Reports Positive Interim Phase 1a ... ABI-1179 was well-tolerated, with a half-life of approximately four days and high exposure across the dose range evaluated supporting the ...

5. biospace.com biospace.com/press-releases/assembly-biosciences-doses-first-participant-in-phase-1b-portion-of-phase-1a-b-clinical-trial-of-investigational-long-acting-herpes-simplex-virus-helicase-primase-inhibitor-abi-1179

Assembly Biosciences Doses First Participant in Phase 1b ... The Phase 1b study will evaluate the safety and antiviral activity of weekly oral doses of ABI-1179 over a 29-day treatment period in participants with ...

6. clinicaltrialsarena.com clinicaltrialsarena.com/news/assembly-study-genital-herpes/

First subject dosed in Assembly Bio's study for genital herpes “With the Phase Ib study of ABI-1179 now underway, we look forward to evaluating viral and clinical outcomes for both promising long-acting HSV ...

7. liverpool.ac.uk liverpool.ac.uk/centre-of-excellence-for-long-acting-therapeutics/global-news/stories/title,1510635,en.php

Assembly Biosciences Reports Positive Interim Phase 1a ... ABI-1179 was well-tolerated with a favorable safety profile observed. ... ABI-1179 study in participants with recurrent genital herpes. This ...

8. investor.assemblybio.com investor.assemblybio.com/news-releases/news-release-details/assembly-biosciences-doses-first-participant-phase-1b-portion

Assembly Biosciences Doses First Participant in Phase 1b ... The Phase 1b study will evaluate the safety and antiviral activity of weekly oral doses of ABI-1179 over a 29-day treatment period in ...

9. investor.assemblybio.com investor.assemblybio.com/news-releases/news-release-details/assembly-biosciences-presents-data-highlighting-recurrent

Press Release Unblinded safety data for ABI-1179 are also included in this presentation. Additional posters presented at STI & HIV 2025 review previously ...