OPT101 for Community-Acquired Pneumonia

Overseen By Marc L Giles, BS

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Op-T LLC

Must not be taking: Immunosuppressants

Disqualifiers: Hepatic dysfunction, Renal dysfunction, HIV, others

Compensation: Varies

Number of Visits: Unknown

Duration: 4 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment, OPT101, for individuals hospitalized with community-acquired pneumonia that has progressed to sepsis (a serious infection causing the body to harm its own tissues). The researchers aim to determine if this drug is safe and tolerable for patients. Participants will receive either the experimental drug or a placebo (a harmless, inactive solution) through an IV. Ideal participants have been hospitalized for pneumonia with severe symptoms, such as high fever or difficulty breathing, and require oxygen support. As a Phase 1 trial, this research focuses on understanding 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 does not specify if you must stop taking your current medications, but it mentions that treatment with certain prohibited medications must be stopped within 5 half-lives before starting the trial and cannot be used during the treatment period. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that OPT101 is likely to be safe for humans?

Research shows that OPT101 is being tested for safety and tolerability in patients with community-acquired pneumonia and sepsis. As a Phase 1 study, researchers are just beginning to test this treatment in humans. This phase typically involves a smaller group of participants to assess how they handle the treatment and identify any possible side effects.

Earlier tests on different groups revealed a safety profile for OPT101 that researchers continue to investigate. Although detailed information is limited, the progression to human trials suggests that initial lab results were promising enough to warrant testing in real patients. However, as this trial is in an early stage, much remains to be learned about the safety of OPT101 for everyone. Participants will be closely monitored to ensure their safety and to address any side effects that might arise promptly. ^{1 2 3 4 5}

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

Researchers are excited about OPT101 because it introduces a novel approach to treating community-acquired pneumonia. Unlike existing antibiotics that target bacteria directly, OPT101 is a 15-mer peptide designed to boost the body's immune response, potentially reducing the reliance on antibiotics and addressing antibiotic resistance. Additionally, it offers a unique delivery method through intravenous infusion, allowing for precise dosage control and potentially faster action. These features make OPT101 a promising candidate for improving pneumonia treatment outcomes.

What evidence suggests that OPT101 might be an effective treatment for Community Acquired Pneumonia with sepsis?

Research has shown that OPT101, which participants in this trial may receive, might help treat Community-Acquired Pneumonia (CAP) with sepsis. This treatment targets a protein called CD40, often elevated in individuals with these conditions. By focusing on CD40, OPT101 aims to reduce inflammation and aid recovery. Early results indicate that OPT101 has manageable side effects and may be effective. Although more information is needed, current evidence is promising for its use in these patients. ^{1 2 3 6 7}

Who Is on the Research Team?

Herbert B Slade, MD FAAAAI

Principal Investigator

Are You a Good Fit for This Trial?

Adults over 18 with Community Acquired Pneumonia and sepsis, needing oxygen but not severe interventions like intubation. They must be able to consent and stay in the hospital for the trial duration. Excluded are pregnant individuals, those with renal or hepatic dysfunction, certain heart conditions, heavy immunosuppression, weight over 250lbs, or allergies to OPT101.

Inclusion Criteria

I am using birth control as a woman able to have children.

Able and willing to give signed informed consent (legally authorized representative can provide informed consent if needed)

I need extra oxygen through a device.

Exclusion Criteria

Pregnancy-related criteria

I expect to leave the hospital or be transferred within 2 days of screening.

My kidney function is low, with an eGFR below 50, or I need dialysis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive OPT101 or placebo for up to 4 days

4 days

Daily visits (in-person) during treatment

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

Regular follow-up visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• OPT101

Trial Overview The study tests OPT101 against a placebo in patients hospitalized with CAP and sepsis. It's blinded for participants and investigators but not the sponsor. The goal is to see if OPT101 is safe and tolerable when given for up to four days.

How Is the Trial Designed?

Group I: OPT101 Experimental Treatment 1 Intervention

OPT101 (15-mer peptide) will be provided across 2 cohorts at 1.1 (cohort 1) and 2.8 mg/kg (cohort 2) doses . On the day of administration, the product will be diluted in saline to result in 50 mL for intravenous (IV) infusion over 120 minutes.

Group II: 0.9% Sodium Chloride Injection USP Placebo Group 1 Intervention

Placebo will be 50mL normal saline (Sodium Chloride), USP sterile solution provided in a 50mL pre-packaged Intravenous (IV) bag.

Who Is Running the Clinical Trial?

Op-T LLC

Lead Sponsor

Trials

3

Recruited

60+

Published Research Related to This Trial

In a clinical development program involving 1684 subjects and 2038 injections, OptiMARK demonstrated a safety profile comparable to Magnevist, with 31% of its injections associated with adverse events.

OptiMARK was found to be safe and well-tolerated, showing fewer adverse events compared to Magnevist (35%) and placebo (48%), indicating its potential as a reliable imaging agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The OptiMARK clinical development program: summary of safety data. Brown, JJ., Kristy, RM., Stevens, GR., et al.[2019]

In a 5-year study at a Finnish tertiary hospital, the Global Trigger Tool (GTT) identified 53 adverse drug events (ADEs) among 834 patient records, indicating a rate of 13 ADEs per 1000 patient-days and affecting 6% of patients.

The study found that as the number of medication-related triggers increased, so did the likelihood of experiencing an ADE, suggesting that the GTT medication module is useful for detecting potential risks, although modifications could enhance its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Global trigger tool as a medication safety tool for adverse drug event detection-a cross-sectional study in a tertiary hospital. Valkonen, V., Haatainen, K., Saano, S., et al.[2023]

The extended Liverpool Adverse Event Profile (E AEP) was used to analyze side effects in 1,605 epilepsy patients and 537 healthy subjects, revealing that many reported symptoms were not directly related to anti-seizure medication (ASM) after normalization for age and gender.

The study found that while medication choice influenced side effect complaints, the E AEP's ability to differentiate between physical and psychological domains was stronger, suggesting that a norm-referenced approach is crucial for accurately assessing treatment-related problems in epilepsy patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Normalization and cross-sectional validation of an extended Adverse Event Profile (E AEP) in a large cohort of patients with epilepsy. Helmstaedter, C., Meschede, C., Mastani, S., et al.[2023]

A review of safety alerts from major health regulatory authorities identified 38 alerts related to ocular adverse events from systemic drugs, with urological medications being the most frequently implicated.

The most common ocular issues reported were visual disorders, such as visual impairment and blurred vision, highlighting the need for physicians to monitor and address these drug-induced effects to prevent progression and potential vision loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug-induced ocular adverse reactions: review of the safety alerts issued during the last decade. Penedones, A., Mendes, D., Alves, C., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06669403

Study Details | NCT06669403 | OPT101 in Patients With ... This study will be performed in patients with Community Acquired Pneumonia (CAP) with Sepsis, who are 18 years or older to evaluate the safety and tolerability ...

2. withpower.com withpower.com/trial/phase-1-pneumonia-1-2025-27fda

OPT101 for Community-Acquired Pneumonia ... OPT101 will have tolerable side effects & efficacy for patients with Community-acquired Pneumonia, Sepsis, Community-acquired Pneumonia and Sepsis. Learn ...

3. ctv.veeva.com ctv.veeva.com/study/opt101-in-patients-with-community-acquired-pneumonia-cap-with-sepsis

OPT101 in Patients With Community Acquired Pneumonia ... This study will be performed in patients with Community Acquired Pneumonia (CAP) with Sepsis, who are 18 years or older to evaluate the safety ...

4. synapse.patsnap.com synapse.patsnap.com/disease/504a27640b18406ab62f60a963c8396f

Community Acquired Pneumonia - Drugs, Targets, Patents A Phase 1b Study to Assess the Safety, Tolerability and Pharmacokinetics of OPT101 in Patients With Community Acquired Pneumonia (CAP) With Sepsis.

5. go.drugbank.com go.drugbank.com/conditions/DBCOND0037905

Community Acquired Pneumonia (CAP) (DBCOND0037905) Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes ... Safety and Efficacy Study of Oral Zabofloxacin in Community Acquired Pneumonia.

6. cdek.pharmacy.purdue.edu cdek.pharmacy.purdue.edu/trial/NCT06669403/

Trial | NCT06669403 This study will be performed in patients with Community Acquired Pneumonia (CAP) with Sepsis, who are 18 years or older to evaluate the safety and tolerability ...

7. synapse.patsnap.com synapse.patsnap.com/drug/3366a14079e4479daff5fd46d87e222b

OPT-101 - Drug Targets, Indications, Patents A Phase 1b Study to Assess the Safety, Tolerability and Pharmacokinetics of OPT101 in Patients With Community Acquired Pneumonia (CAP) With ...