Sabiad Pipeline

Advancing from preclinical success to Phase 0 clinical trials for Staphylococcus aureus infections.

PHASE 0

Why phase 0 clinical trials matter

Phase 0 clinical trials mark a crucial milestone in bringing new technologies from the lab to real-world clinical use. As a first-in-human study, Phase 0 trials allow us to gather essential data on the safety, behavior, and pharmacokinetics of our 1D9 platform in humans.

This phase is designed to test minimal product doses in a limited number of participants, giving us valuable insights into how the theranostic agent works in the human body.

The benefits of a Phase 0 study include:

  • Early Validation in Humans: It helps us confirm that the 1D9 platform behaves as expected based on preclinical results, providing confidence as we move into later, more extensive clinical trials.
  • De-Risking Future Trials: By collecting safety and efficacy data early on, we reduce the risks associated with progressing to Phase 1 and Phase 2 trials, ensuring a more streamlined development process.
  • Accelerating Development: Phase 0 allows us to make informed decisions faster, identifying any potential issues at an earlier stage. This can save both time and resources in the long run.
  • Early Validation in Humans: It helps us confirm that the 1D9 platform behaves as expected based on preclinical results, providing confidence as we move into later, more extensive clinical trials.
  • De-Risking Future Trials: By collecting safety and efficacy data early on, we reduce the risks associated with progressing to Phase 1 and Phase 2 trials, ensuring a more streamlined development process.
  • Accelerating Development: Phase 0 allows us to make informed decisions faster, identifying any potential issues at an earlier stage. This can save both time and resources in the long run.

At Sabiad, this phase is key in validating our theranostics platform’s dual capability—accurately diagnosing infections and targeting them with tailored therapies.

The results of this Phase 0 study will set the foundation for the next phases of development, bringing us closer to transforming infection management and improving patient outcomes.

Sabiad Pipeline

Program
Preclinical
Phase 0
Phase 1
Administration
Modality
Indication
Dx/Tx
Notes
In vivo
1D9 + 89Zirconium (molecular imaging)
Intravenous
PET-CT
Prosthetic joint infections (PJIs)/Fracture Related Infections
Dx
Phase 0 enrolling 15 patients in the Netherlands UMCG
1D9-CW800 (fluorescent imaging)
Intravenous/topical/popliteal injection
Near infrared camera
Prosthetic joint infections (PIJs)/Fracture Related Infection (FRI), during surgery/post-surgery/arthoscopy
Dx
Phase 0 scheduled to commence in 2025
1D9 + light + 700DX
Intravenous
Laser/LED
Prosthetic joint infections (PIJs)/Fracture Related Infections (FRI)
Tx
1D9-radio theranostics
Intravenous
PET-CT (Radio isotopes)
Prosthetic joint infections (PJIs) / Fracture Related Infection (FRI)
Tx
Ex vivo
1D9+ RAPPID (bioluminesense)
Diagnostic Kit
Luminometer
Synovial Fluid Point of Care test
Dx
Project enrolling in Northern Netherlands 4 hospitals.
1D9+ RAPPID (bioluminesense)
Selftest
Luminometer
S. aureus Point of Care selftest
Dx

Sabiad Pipeline

1D9 + 89Zirconium (molecular imaging)
Program
1D9 + 89Zirconium (molecular imaging)
In vivo/ex vivo
In vivo
Administration
Intravenous
Modality
PET-CT
Indication
Prosthetic joint infections (PJIs) / Fracture Related Infection (FRI)
Dx/Tx
Dx
Notes
Phase 0 enrolling 15 patients in the Netherlands UMCG.
Preclinical
Program
1D9 – CW800 (fluorescent imaging)
In vivo/ex vivo
In vivo
Administration
Intravenous/topical / popliteal injection
Modality
Near Infrared camera
Indication
Prosthetic joint infections (PJIs) / Fracture Related Infection (FRI), during surgery / post surgery / arthroscopy
Dx/Tx
Dx
Notes
Phase 1 scheduled to commence in 2025.
Preclinical
Program
1D9 + light + 700DX
In vivo/ex vivo
In vivo
Administration
Intravenous
Modality
Laser / LED
Indication
Prosthetic joint infections (PJIs) / Fracture Related Infection (FRI)
Dx/Tx
Tx
Preclinical
Program
1D9 – radio theranostics
In vivo/ex vivo
In vivo
Administration
Intravenous
Modality
PET-CT / LINAC (Radio isotopes)
Indication
Prosthetic joint infections (PJIs) / Fracture Related Infection (FRI)
Dx/Tx
Tx
Preclinical
1D9 + RAPPID (bioluminesence)
Program
1D9 + RAPPID (bioluminesence)
In vivo/ex vivo
Ex vivo
Administration
Diagnostic Kit
Modality
Luminometer
Indication
Synovial Fluid Point of Care test
Dx/Tx
Dx
Preclinical
Program
1D9 + RAPPID (bioluminesence)
In vivo/ex vivo
Ex vivo
Administration
Selftest
Modality
Luminometer
Indication
S. aureus Point of Care selftest
Dx/Tx
Dx
Preclinical
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