Navenibart for Hereditary Angioedema

Age: Any Age

Sex: Any

Trial Phase: Phase 3

Sponsor: Astria Therapeutics, Inc.

Must not be taking: ACE inhibitors, Estrogen

Disqualifiers: Other clinical trials, Sensitivity to ingredients

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety and effectiveness of a treatment called navenibart for individuals with hereditary angioedema (HAE), a condition that causes severe swelling. The trial consists of two parts: initially, all participants receive a set dose of navenibart, and later, doses are adjusted based on individual needs. Participants will receive different dosing regimens, such as 300 mg or 600 mg, at varying intervals. This trial is suitable for those who participated in a previous study (STAR-0215-301) and have hereditary angioedema. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to potentially bringing a new treatment to market.

Will I have to stop taking my current medications?

You will need to stop taking any ACE inhibitors or estrogen-containing medications (like certain birth control pills or hormone therapies) at least 30 days before joining the trial. The protocol does not specify other medications, so it's best to discuss your current medications with the trial team.

Is there any evidence suggesting that navenibart is likely to be safe for humans?

A previous study found navenibart safe for patients, even at doses up to 1200 mg, with most participants experiencing no serious side effects. Research has shown that navenibart remains in the body for an extended period, helping to reduce the frequency and severity of hereditary angioedema (HAE) attacks. Another study compared navenibart to a placebo, examining its safety and effectiveness in preventing HAE attacks. These studies suggest that navenibart is generally safe for individuals with HAE. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for hereditary angioedema?

Navenibart is unique because it offers a new dosing flexibility for treating hereditary angioedema, which could be more convenient for patients. Most current treatments for this condition, like C1 inhibitors or bradykinin receptor antagonists, require more frequent administrations. Navenibart allows for less frequent dosing, with options for either a 3-month or 6-month interval, potentially improving adherence and lifestyle for patients. Additionally, the option to adjust dosing based on age and specific needs could make it more adaptable to individual patient circumstances. Researchers are excited about the potential for Navenibart to simplify treatment regimens and enhance quality of life for patients.

What evidence suggests that this trial's treatments could be effective for hereditary angioedema?

Research has shown that navenibart can significantly reduce the frequency and severity of hereditary angioedema (HAE) attacks. This trial will test different dosing regimens of navenibart, allowing participants to receive it every 3 or 6 months. Studies have found that navenibart helps prevent these attacks for extended periods. The treatment is generally safe and well-tolerated. Participants in those studies experienced fewer HAE attacks and required less emergency medication during attacks. Overall, navenibart offers hope for lasting relief from HAE symptoms. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

This clinical trial is for adults and adolescents with hereditary angioedema (HAE) who were previously part of the STAR-0215-301 study. Specific eligibility criteria are not provided, but typically participants must meet certain health standards to be included.

Inclusion Criteria

Completed STAR-0215-301 through the Day 181 visit

Withdrew from STAR-0215-301 but met the following criteria: Received 2 doses of IP, completed ≥ 2 months of trial follow-up after the second dose of IP, Met other eligibility criteria as assessed by Investigator

Participants from STAR-0215-301 who met one of the following conditions:

Exclusion Criteria

Known sensitivity to the ingredients in the formulation of IP

I haven't been in any clinical trials or taken any experimental drugs recently, except for navenibart in STAR-0215-301.

I haven't taken ACE inhibitors or estrogen medications in the last 30 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive navenibart in a dose-controlled fashion

Long-term

Every 3 to 6 months

Treatment Part 2

Participants receive personalized dosing option (PDO) based on individual needs

Long-term

Every 3 to 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Navenibart

Trial Overview The trial is testing navenibart's long-term safety and effectiveness in two parts: initially providing a controlled dose to all participants, followed by personalized dosing based on individual needs.

How Is the Trial Designed?

Group I: Adult Dosing Regimen 3 Experimental Treatment 1 Intervention

Participants will receive 600 mg of navenibart every 6 months.

Group II: Adult Dosing Regimen 2 Experimental Treatment 1 Intervention

Participants will receive 300 mg of navenibart every 3 months.

Group III: Adult Dosing Regimen 1 Experimental Treatment 1 Intervention

Participants will receive 600 mg of navenibart every 3 months.

Group IV: Adolescent Dosing Regimen 1 Experimental Treatment 1 Intervention

Participants will receive 300 mg of navenibart every 3 months.

Who Is Running the Clinical Trial?

Astria Therapeutics, Inc.

Lead Sponsor

Trials

5

Recruited

310+

Citations

1. ir.astriatx.com ir.astriatx.com/news-releases/news-release-details/astria-therapeutics-announces-final-positive-results-all

Astria Therapeutics Announces Final Positive Results from ... These results reinforce the potential of navenibart's profile to provide effective, long-acting prevention from HAE attacks and highlight ...

2. annallergy.org annallergy.org/article/S1081-1206(25)00520-4/fulltext

FINAL RESULTS FROM ALPHA-STAR, A PHASE 1B/2 ... Navenibart robustly and durably decreased the HAE attack rate with a favorable safety profile. Every 3- and 6-month regimens are currently being investigated in ...

3. jacionline.org jacionline.org/article/S0091-6749(24)01898-0/fulltext

Treatment with Navenibart (STAR-0215) Reduces Attack ... This interim analysis suggests that navenibart reduces the burden of HAE, assessed by reduction in HAE attack frequency, severity and use of rescue medication.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06842823

NCT06842823 | A Study of Navenibart in Participants With ... The goal of this clinical trial is to evaluate the efficacy and safety of navenibart compared to placebo in preventing HAE attacks in participants with HAE.

5. sciencedirect.com sciencedirect.com/science/article/pii/S108112062500153X

Safety and pharmacokinetics of long-acting plasma ... In this first-in-human study, up to 1200 mg of navenibart was well tolerated and demonstrated an extended half-life with durable plasma kallikrein inhibition.

6. astriatx.com astriatx.com/our-science/our-pipeline/star-0215/

Navenibart (STAR-0215) Navenibart is in clinical development for the treatment of hereditary angioedema. ... safety and tolerability profile, reduction in the mean monthly attack ...

7. ir.astriatx.com ir.astriatx.com/news-releases/news-release-details/astria-therapeutics-announces-positive-initial-results-alpha

Astria Therapeutics Announces Positive Initial Results from ... Navenibart demonstrated overall attack-freedom of 50% over six months, which is the longest period of follow-up for all 16 patients to date.