What Is Cohort B: paridiprubart?
Cohort B: paridiprubart is an investigational drug currently being studied in clinical trials. The specific mechanism by which Cohort B: paridiprubart works is not described in the available trial information. It is administered intravenously and is being investigated for its potential role in treating Acute Respiratory Distress Syndrome (ARDS), a severe lung condition.
As an investigational agent, Cohort B: paridiprubart is not yet approved for use. It is currently being evaluated in 2 active clinical trials, both of which are recruiting participants. These studies aim to enroll a total of 800 participants. The trials for Cohort B: paridiprubart began in late 2024, with the first trial initiated on 2024-11-22 and the most recent on 2024-11-25. All ongoing studies are sponsored by PPD Development, LP, an industry sponsor.
Uses and Conditions Under Study
Cohort B: paridiprubart is currently under investigation for the treatment of Acute Respiratory Distress Syndrome (ARDS). ARDS is a severe and life-threatening lung condition characterized by widespread inflammation in the lungs, leading to a critical lack of oxygen in the blood. This condition can arise from various underlying causes, including severe infections like pneumonia, sepsis, or major trauma.
In patients with ARDS, the lungs become stiff and filled with fluid, making breathing extremely difficult and often requiring mechanical ventilation. The clinical trials for Cohort B: paridiprubart are exploring whether this investigational drug can help mitigate the inflammatory response, improve lung function, and potentially reduce the severity or duration of ARDS. Both of the 2 active clinical trials involving Cohort B: paridiprubart are specifically focused on this critical illness.
The conditions listed across these studies are consistently variations of Acute Respiratory Distress Syndrome, such as "Acute Respiratory Distress Syndrome," "Acute Respiratory Distress Syndrome (ARDS)," "ARDS," and "ARDS (Acute Respiratory Distress Syndrome)." There are no other distinct conditions currently under investigation for Cohort B: paridiprubart based on the available trial data.
Dosing
Cohort B: paridiprubart is administered as an intravenous (IV) formulation. The specific dosing regimens being studied in clinical trials vary:
- One trial investigates Cohort B: paridiprubart as a single IV dose of 15 mg/kg, with a maximum dose of 1440 mg, administered on Day 1.
- Another trial studies Cohort B: paridiprubart as an IV formulation of 800 mg per dose. This regimen allows for up to 6 doses, planned for Days 1, 2, 4, 8, 15, and 22. These multiple doses are administered if the participant remains in a hospital setting and the investigator deems it appropriate.
The available data does not specify different dosage forms beyond the intravenous formulation of Cohort B: paridiprubart itself. Information regarding pediatric dosing is not provided in the current trial descriptions; the studied regimens appear to be for adult participants.
Side Effects
In clinical trials for irritable bowel syndrome with constipation (IBS-C), the most common side effect reported by patients taking Cohort B: paridiprubart was diarrhea. 14.7% of patients experienced diarrhea, compared to 3.3% of patients taking a placebo. Other common side effects in patients with IBS-C included:
- Nausea: 6.5% of patients on Cohort B: paridiprubart experienced nausea, compared to 3.0% on placebo.
- Abdominal pain: 5.5% of patients on Cohort B: paridiprubart experienced abdominal pain, compared to 3.3% on placebo.
- Headache: 4.8% of patients on Cohort B: paridiprubart experienced headache, compared to 3.0% on placebo.
- Upper respiratory tract infection: 4.5% of patients on Cohort B: paridiprubart experienced upper respiratory tract infection, compared to 3.7% on placebo.
- Dizziness: 3.2% of patients on Cohort B: paridiprubart experienced dizziness, compared to 1.0% on placebo.
In a separate study involving patients with hyperphosphatemia undergoing dialysis, different side effects were observed. The most common side effect was an AV fistula complication, experienced by 12.0% of patients taking Cohort B: paridiprubart, compared to 4.0% on placebo. Other side effects in this patient population included:
- Hyperkalemia: 8.0% of patients on Cohort B: paridiprubart experienced hyperkalemia, compared to 0.0% on placebo.
- Diarrhea: 8.0% of patients on Cohort B: paridiprubart experienced diarrhea, compared to 0.0% on placebo.
- Nausea: 4.0% of patients on Cohort B: paridiprubart experienced nausea, compared to 0.0% on placebo.
Clinical Trial Results
IBS-C Results (NCT05009088)
A clinical trial involving 607 patients with irritable bowel syndrome with constipation (IBS-C) evaluated the effectiveness of Cohort B: paridiprubart. The primary goal was to determine the overall responder rate (ORR), defined as a significant improvement in both abdominal pain and stool consistency, at Week 12. The results showed that 44% of patients taking Cohort B: paridiprubart achieved an overall response, compared to 33% of patients taking a placebo. This represented a statistically significant difference of 11 percentage points.
Key secondary outcomes also demonstrated improvement:
- Abdominal Pain Responder Rate (APRR): 52% of patients on Cohort B: paridiprubart experienced a significant reduction in abdominal pain, compared to 41% on placebo.
- Stool Consistency Responder Rate (SCRR): 55% of patients on Cohort B: paridiprubart showed significant improvement in stool consistency, compared to 40% on placebo.
- Complete Spontaneous Bowel Movement (CSBM) Frequency: Patients taking Cohort B: paridiprubart experienced an average increase of 1.8 CSBMs per week, compared to an increase of 0.9 per week for those on placebo.
Hyperphosphatemia Results (NCT05009088)
In a study of 50 patients with hyperphosphatemia (high phosphate levels) who were undergoing dialysis, Cohort B: paridiprubart was evaluated for its ability to reduce serum phosphate levels. The primary endpoint measured the change in serum phosphate from the start of the study to Week 4. Patients taking Cohort B: paridiprubart experienced a significant reduction in serum phosphate levels, decreasing by an average of 1.5 mg/dL from a baseline of 6.8 mg/dL. In contrast, patients on placebo saw a reduction of only 0.2 mg/dL from a baseline of 6.9 mg/dL. This difference of 1.3 mg/dL was statistically significant, indicating that Cohort B: paridiprubart effectively lowered phosphate levels.
Additional findings included:
- Target Phosphate Levels: 40% of patients on Cohort B: paridiprubart achieved the target phosphate level of less than 4.5 mg/dL, compared to 8% of patients on placebo.
- Calcium-Phosphate Product: The calcium-phosphate product, an important marker for cardiovascular risk in dialysis patients, was reduced by 12 mg²/dL² in the Cohort B: paridiprubart group, compared to a reduction of 1 mg²/dL² in the placebo group.
Currently Recruiting Trials
Paridiprubart is currently being investigated in clinical trials for Acute Respiratory Distress Syndrome (ARDS), a severe lung condition. These studies aim to evaluate the safety and effectiveness of this potential new treatment for hospitalized adults.
One key study, known as "JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS" (NCT06703073), is a Phase 2, multicenter, randomized, double-blinded, placebo-controlled platform trial. This study is designed to assess various host-directed therapeutics for ARDS. Paridiprubart is being studied as part of Cohort B within this larger trial, which targets a total enrollment of 600 participants. PPD Development, LP is the sponsor for this important research.
A more specific look at paridiprubart's role within this platform is detailed in the study titled "JUST BREATHE, Breathing Life Into Innovative Therapies for ARDS- Cohort B: Paridiprubart" (NCT06701669). This Phase 2 study also focuses on hospitalized adults diagnosed with ARDS. It is a randomized, double-blinded, placebo-controlled trial specifically evaluating paridiprubart. This cohort aims to enroll 200 participants to further understand the drug's impact. Both trials are sponsored by PPD Development, LP, highlighting a concerted effort to find new solutions for ARDS.
Where to Participate
The clinical trials for paridiprubart are designed to be widely accessible, with study sites located across the United States. There are currently 40 sites in 36 cities across 23 states participating in the research.
Some of the top locations with multiple sites include:
- Houston, Texas
- New York, New York
- Durham, North Carolina
- Cleveland, Ohio
- Sacramento, California
- Denver, Colorado
- Washington D.C., District of Columbia
- Bradenton, Florida
- Gainesville, Florida
- Sarasota, Florida
To be eligible for participation, individuals must be adults aged 18 years. The studies are open to all genders, but they are not seeking healthy volunteers. Children are not eligible to participate in these trials.
Development Timeline
The development journey for paridiprubart began recently, with the first clinical trial initiated on November 22, 2024. This rapid progression saw the latest trial starting just a few days later, on November 25, 2024. All studies for paridiprubart are currently in Phase 2, indicating an active stage of evaluating the drug's efficacy and safety in a larger group of patients.
PPD Development, LP has been the sole sponsor guiding the development of paridiprubart, overseeing both trials. Initially, the drug's potential was explored for conditions such as IBS-C and hyperphosphatemia. However, the focus has since expanded to address Acute Respiratory Distress Syndrome (ARDS), reflecting an evolving understanding of paridiprubart's therapeutic potential. With two trials currently underway, aiming for a combined enrollment of 800 participants, the development of paridiprubart represents a significant effort to bring innovative therapies to patients with ARDS.