RABI-767 for Acute Pancreatitis

Recruiting at 12 trial locations

Overseen By Kelly Abernathy

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Panafina, Inc.

Disqualifiers: Severe pancreatitis, Pancreatic necrosis, Cholangitis, others

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

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called RABI-767 to determine its safety and effectiveness for people with severe acute pancreatitis, a painful condition involving inflammation of the pancreas. Participants will receive either a single dose of RABI-767 with standard care or standard care alone. The goal is to compare the effectiveness of RABI-767 against usual care. This trial targets individuals diagnosed with acute pancreatitis who are not showing significant improvement after hospital admission. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important medical advancements.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that RABI-767 is likely to be safe for humans?

Research has shown that RABI-767 is being tested for safety in people with severe acute pancreatitis. Although specific safety data from past studies is not yet available, its presence in a mid-phase trial suggests earlier tests have indicated it to be fairly safe. This reduces the likelihood of serious safety issues, but participants must still be closely monitored for any unwanted side effects. The trial aims to learn more about the safety of this treatment when administered in a single dose using a method called EUS-guided peripancreatic injection, which allows doctors to inject the treatment directly near the pancreas. Participants should discuss any concerns with the trial team before joining. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acute pancreatitis?

RABI-767 is unique because it combines with the standard-of-care to potentially enhance treatment for acute pancreatitis. Unlike traditional treatments that primarily focus on addressing symptoms and complications, RABI-767 is designed to target the underlying inflammation directly with a novel mechanism of action. Researchers are excited about this treatment because it could offer quicker relief and improved outcomes by working synergistically with existing therapies.

What evidence suggests that RABI-767 might be an effective treatment for acute pancreatitis?

Research has shown that RABI-767 might help with severe acute pancreatitis. In this trial, one group of participants will receive a single dose of RABI-767 near the pancreas using a special ultrasound tool, along with standard-of-care treatment. RABI-767 aims to reduce swelling and speed up recovery in the pancreas. Although detailed information from human studies remains limited, early animal studies and ongoing research suggest it could be effective. The treatment targets the problem area directly, potentially making it more effective than general treatments. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

This trial is for people with severe acute pancreatitis, confirmed by specific imaging tests (CECT or CEMRI), who haven't improved significantly since being admitted to the hospital. Participants must be suitable for a procedure that uses an endoscope to deliver the study drug near the pancreas.

Inclusion Criteria

Lack of clinically meaningful improvement from status at admission, at the discretion of Investigator, at the time of randomization

I have been diagnosed with acute pancreatitis.

I am at high risk for severe acute pancreatitis.

Exclusion Criteria

Anticipated discharge from hospital within 48 hours of randomization

I have been diagnosed with severe acute pancreatitis.

My pancreas has areas of dead tissue seen on a special scan.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of RABI-767 via EUS-guided peripancreatic injection plus standard-of-care or standard-of-care only

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 days

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• RABI-767

Trial Overview The trial is testing RABI-767, administered once via an endoscopic ultrasound around the pancreas, against supportive care alone. The goal is to see if this single dose can safely and effectively treat severe acute pancreatitis.

How Is the Trial Designed?

Group I: RABI-767 plus Standard-of-Care Experimental Treatment 1 Intervention

Single-dose 125 mg RABI-767 plus standard-of-care

Group II: Standard-of-Care Only Active Control 1 Intervention

No Intervention, Standard-of-Care Only

RABI-767 is already approved in United States for the following indications:

Approved in United States as RABI-767 for:

• None - Currently under investigation for acute pancreatitis, not yet approved

Who Is Running the Clinical Trial?

Panafina, Inc.

Lead Sponsor

Trials

1

Recruited

40+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06080789

NCT06080789 | A Study to Evaluate the Safety and ... Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection effective in treating patients with predicted severe acute pancreatitis. Study ...

2. reporter.nih.gov reporter.nih.gov/project-details/11124672

Project Details We are here proposing a companion animal trial to study the clinical response to RABI-767 using different dosing schedules, with two primary goals, 1) to ...

3. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06080789/

Trial | NCT06080789 Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection effective in treating patients with predicted severe acute pancreatitis. Study ...

4. ufhealth.org ufhealth.org/clinical-trials/panafina-rabi-767-201

Panafina RABI-767-201 Is a single-dose of RABI-767 given by EUS-guided peripancreatic injection effective in treating patients with predicted severe acute pancreatitis. Study ...

5. uams.trialstoday.org uams.trialstoday.org/trial/NCT06080789

Translational Research Institute The goal of this clinical trial is to test the safety and effectiveness of a single dose of RABI-767 given by endoscopic ultrasound (EUS) guided peripancreatic ...

6. empr.com empr.com/home/news/drugs-in-the-pipeline/novel-lipase-inhibitor-gets-fast-track-status-for-acute-pancreatitis/

Novel Lipase Inhibitor Gets Fast Track Status for Acute ... “RABI-767 has the potential to improve patient outcomes, avoid lengthy hospitalizations and save lives,” said Dr Tim Gardner, professor at The ...