KSP-1007 + Meropenem for Bacterial Infections

Overseen By Sam Azoulay, M.D.

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Sumitovant Biopharma, Inc.

Must not be taking: β-lactams, β-lactamase inhibitors

Disqualifiers: Gilbert's Syndrome, Pregnant, Lactating, others

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and behavior of a new drug, KSP-1007, in the body. Researchers are exploring its effects both alone and in combination with the existing antibiotic, meropenem. Different groups in the study will receive varying doses, with some receiving a placebo (a substance with no therapeutic effect) for comparison. Healthy individuals without a history of severe allergic reactions and without liver or kidney issues might be suitable for this trial. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves healthy subjects and has specific exclusion criteria, it's possible that you may need to pause certain medications. Please consult with the trial coordinators for more details.

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

Research has shown that KSP-1007 is a new drug under development for treating difficult bacterial infections. It is intended for use with meropenem, a well-known antibiotic. Studies suggest that KSP-1007 could be effective when combined with meropenem.

KSP-1007 remains in the early testing stages, with researchers primarily assessing its safety for humans. This marks the first time the drug is being tested in people, so detailed information on side effects or tolerability is not yet available.

Since meropenem is already an approved antibiotic, its safety profile is well understood. Researchers are familiar with its mechanism in the body and the potential side effects.

Joining this trial involves some risk, as the main goal is to observe the body's reaction to the new drug. However, this phase is crucial for researchers to learn about its safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard antibiotics used to treat bacterial infections, KSP-1007 represents a novel approach due to its unique mechanism of action. While typical antibiotics like penicillin or cephalosporins disrupt bacterial cell walls, KSP-1007 specifically targets bacterial DNA replication, potentially offering a new way to combat resistant strains. Researchers are particularly excited about KSP-1007 because it not only works on its own but may also enhance the effectiveness of existing antibiotics like meropenem when used together, potentially overcoming resistance issues and improving treatment outcomes.

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

Research has shown that KSP-1007, one of the treatments in this trial, could effectively treat bacterial infections. Studies have found it works well against hard-to-treat bacteria, especially those resistant to antibiotics like carbapenems. In this trial, some participants will receive KSP-1007 with another antibiotic, meropenem. Previous studies found this combination particularly effective against tough bacteria like A. baumannii. Lab tests suggest this combination might outperform other treatments, except for a few like cefiderocol. Early evidence indicates that KSP-1007 could become a strong option for treating resistant bacterial infections. ^{1 2 4 6 7}

Who Is on the Research Team?

Hayes Dansky, M.D.

Principal Investigator

Sumitovant Biopharma, Inc.

Are You a Good Fit for This Trial?

Inclusion Criteria

Females that engage in heterosexual activity must agree to use a highly selective birth control (BC) method (< 1% failure rate per year) throughout the study, or have a documented reproductive status of non-childbearing based on medical history, or is postmenopausal

Males that engage in heterosexual activity that has the risk of pregnancy must agree to use effective BC and agree to not donate sperm during the study and for at least 90 days after the last dose of the study medication

Body mass index (BMI) 2: 18 kg/m2 and :s 32 kg/m2

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and repeat escalating doses of KSP-1007, alone and coadministered with meropenem

Up to 5 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 14 days

What Are the Treatments Tested in This Trial?

Interventions

• KSP-1007
• Meropenem
• Placebo:0.9% sodium chloride

How Is the Trial Designed?

Group I: KSP-1007 single ascending dose Experimental Treatment 1 Intervention

Single, ascending intravenous dose of KSP-1007

Group II: KSP-1007 multiple ascending dose + Meropenem multiple dose Experimental Treatment 2 Interventions

Multiple, ascending intravenous doses of KSP-1007 and multiple doses of meropenem (fixed dose)

Group III: KSP-1007 multiple ascending dose Experimental Treatment 1 Intervention

Multiple, ascending, intravenous doses of KSP-1007

Group IV: Placebo single dose Placebo Group 1 Intervention

Single dose of placebo (0.9% normal saline)

Group V: Placebo multiple dose Placebo Group 1 Intervention

Multiple doses of placebo (0.9% saline)

Group VI: Placebo + Meropenem multiple dose Placebo Group 2 Interventions

Multiple doses of placebo (0.9% normal saline) plus multiple doses of meropenem (fixed dose)

Who Is Running the Clinical Trial?

Sumitovant Biopharma, Inc.

Lead Sponsor

Trials

1

Recruited

120+

Citations

1. journals.asm.org journals.asm.org/doi/10.1128/aac.01602-23

In vitro and in vivo activities of KSP-1007, a broad-spectrum ... The free concentration of 30 mg/kg of KSP-1007 observed to be effective in the urinary tract and thigh infection models exceeded 8 µg/mL (data ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38709005/

In vitro and in vivo activities of KSP-1007, a broad ... MEM/KSP-1007 at 8 µg/mL showed greater efficacy against A. baumannii than these comparators except for cefiderocol, tigecycline, and colistin. ...

3. sumitomo-pharma.com sumitomo-pharma.com/news/20230619.html

Joint Research between The Kitasato Institute and ... KSP-1007 is expected to become an effective treatment option against carbapenem-resistant bacterial infections in combination with meropenem hydrate.

4. journals.asm.org journals.asm.org/doi/abs/10.1128/aac.01602-23

In vitro and in vivo activities of KSP-1007, a broad-spectrum ... MEM/KSP-1007 showed excellent activity against Escherichia coli with PBP3 mutations and New Delhi metallo-β-lactamase compared to aztreonam/ ...

5. withpower.com withpower.com/trial/phase-1-infections-2022-2ae2d

Study of the Safety and Pharmacokinetics of KSP-1007 ... Meropenem is an antibiotic used to treat serious infections. The study involves healthy Japanese individuals to check if the drug is safe and well-tolerated.

6. delta.larvol.com delta.larvol.com/Products/?ProductId=dee91a62-8259-43b4-8c1a-b8c105fe342c

KSP-1007 / Sumitomo Pharma, The Kitasato Institute Safety, Tolerability, And Pharmacokinetics Of KSP-1007 After Single And Multiple Ascending Doses Alone Or In Combination With Meropenem In Healthy Subjects ...

7. researchgate.net researchgate.net/publication/380373004_In_vitro_and_in_vivo_activities_of_KSP-1007_a_broad-spectrum_inhibitor_of_serine-_and_metallo-b-lactamases_in_combination_with_meropenem_against_carbapenem-resistant_Gram-negative_bacteria

In vitro and in vivo activities of KSP-1007, a broad ... This report describes the first safety and pharmacokinetic data following oral administration as the isobutyryloxymethyl prodrug in humans. Methods Forty ...