LTG-001 for Acute Pain

Overseen By Todd Bertoch, MD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Latigo Biotherapeutics

Must not be taking: NSAIDs, Benzodiazepines, Opioids, others

Disqualifiers: Hepatic function, Heart disease, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 hours

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, LTG-001, as a potential pain reliever to determine its effectiveness in relieving pain after wisdom tooth surgery. Researchers aim to assess whether LTG-001 alleviates pain for 12 hours and if it is safe. Participants will be compared against a placebo (a pill with no active drug) and another pain relief option. Ideal candidates have at least two impacted wisdom teeth needing removal and experience significant pain after surgery. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to early-stage pain relief advancements.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but it excludes those who use NSAIDs, benzodiazepines, opioids, or medications that affect heart rhythms. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found LTG-001 to be well tolerated by 72 healthy participants. Most did not experience major side effects, and the drug was absorbed quickly, suggesting it might provide fast pain relief.

Research shows Suzetrigine is generally safe. Most side effects were mild, such as headaches, occurring in about 7% of participants. This suggests both treatments are manageable for most people.

This trial is in Phase 2, indicating some safety data is available, but researchers are still gathering more information on the treatments' effectiveness and safety in a larger group. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about LTG-001 for acute pain because it offers a potentially faster-acting and more precise approach to pain relief. Unlike standard medications like opioids or NSAIDs, LTG-001 is designed to target specific pain pathways, which could lead to fewer side effects and reduced risk of dependency. Additionally, LTG-001 is being tested in various doses (low, mid, and high), allowing for tailored pain management that could optimize effectiveness while minimizing adverse effects. With these innovative features, LTG-001 could represent a significant advancement in acute pain treatment.

What evidence suggests that LTG-001 might be an effective treatment for acute pain after wisdom teeth removal?

Studies have shown that LTG-001 looks promising for treating sudden pain. In trials with 72 healthy volunteers, LTG-001 was well tolerated and quickly absorbed by the body. This rapid absorption suggests it might provide fast pain relief, ideal for post-surgical pain, such as after wisdom teeth removal. The drug blocks a specific pathway involved in pain signals, offering a potential non-opioid option for pain management. Participants in this trial may receive different doses of LTG-001 or a comparator treatment to evaluate its effectiveness and safety. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults who've had their impacted third molars (wisdom teeth) surgically removed and are experiencing acute pain can participate. Specific details about eligibility criteria are not provided, but typically participants must be in good health aside from the condition being studied.

Inclusion Criteria

My post-surgery pain fits the study's criteria.

Subject must agree to study required use of birth control

I need to have 2 or more wisdom teeth removed, including at least 2 lower ones that are partially or fully covered by bone.

Exclusion Criteria

I cannot take medications by mouth.

I have sleep apnea or use a CPAP machine at home.

I haven't had dental or other surgeries in the last 60 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants take LTG-001 one time after the surgical removal of impacted third molars and remain at the clinic for 12 hours for monitoring

12 hours

1 visit (in-person)

Follow-up

Participants return after a week for a safety check-up

1 week

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• LTG-001

Trial Overview The trial is testing LTG-001's effectiveness in treating post-surgical pain after wisdom tooth removal. It involves a single dose of LTG-001 at various strengths or a placebo, with patients monitored for 12 hours post-dosing and returning after a week for safety evaluation.

How Is the Trial Designed?

Group I: LTG-001 Mid Dose Experimental Treatment 1 Intervention

Group II: LTG-001 Low Dose Experimental Treatment 1 Intervention

Group III: LTG-001 High Dose Experimental Treatment 1 Intervention

Group IV: Suzetrigine Active Control 1 Intervention

Group V: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Latigo Biotherapeutics

Lead Sponsor

Trials

4

Recruited

480+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06774625

NCT06774625 | This is a Study Evaluating the Efficacy ... The goal of this clinical trial is to learn if LTG-001 works to treat pain after third molar removal surgery in adults. It will also learn about the safety of ...

2. latigobio.com latigobio.com/latigo-biotherapeutics-announces-positive-phase-1-data-for-lead-non-opioid-pain-medicine-candidate/

Latigo Biotherapeutics Announces Positive Phase 1 Data ... Results from the Phase 1 clinical trial in 72 healthy subjects showed that LTG-001 was well tolerated and demonstrated rapid absorption with a T ...

3. prnewswire.com prnewswire.com/news-releases/latigo-biotherapeutics-granted-fda-fast-track-designation-for-ltg-001--potential-best-in-class-nav1-8-inhibitor-for-the-non-opioid-treatment-of-acute-pain-302387994.html

Latigo Biotherapeutics Granted FDA Fast Track ... Results from the trial with 72 healthy subjects showed that LTG-001 was well tolerated and demonstrated rapid absorption with a Tmax of about ...

4. enterprises.upmc.com enterprises.upmc.com/resources/insights/reimagining-relief-fostering-innovation-in-pain-management/

Reimagining Relief: Fostering Innovation in Pain ... In the Phase 1 first-in-human clinical trial, data showed that LTG-001 was well tolerated with rapid absorption.

5. clinicalpainadvisor.com clinicalpainadvisor.com/news/ltg-001-fast-tracked-nonopioid-treatment-acute-pain/

FDA Fast Tracks Investigational Nonopioid Treatment for ... Results showed LTG-001 demonstrated rapid absorption (Tmax ~1.5 hours), suggesting the investigational therapy may provide quick pain relief.

6. rheumatologyadvisor.com rheumatologyadvisor.com/news/ltg-001-fast-tracked-nonopioid-treatment-acute-pain/

FDA Fast Tracks Investigational Nonopioid Treatment for ... Results showed LTG-001 demonstrated rapid absorption (Tmax ~1.5 hours), suggesting the investigational therapy may provide quick pain relief.