Project: NI01 MRSA nasal decolonization, bacterial pneumonia & topical skin infections

Our lead biologic, NI01, is a potent bactericidal peptide with promising efficacy for topical use, offering key advantages over existing antibiotic drugs.

Our initial focus with NI01 is for use in nasal decolonization of MRSA - currently treated using mupirocin which has relatively poor efficacy and sees a high chance of infection recurrence.

Minor modifications to the NI01 peptide sequence have generated a family of novel therapeutics with a wide range of potent antibacterial activity. These variants have the potential to be successful in the treatment of pneumonia and surface skin infections such as impetigo. Their development will follow success of the MRSA decolonisation programme.

You can follow the progress of our developments below.
View project pipeline

Project pipeline

PRE-2019

Nasal decolonisation: R&D

£1.2m SBRI-funded two year R&D project begins, taking our lead compound NI01 through a full pre-clinical ADMET work-up.
2019

Nasal decolonisation: Pre-clinical toxicology

Toxicology studies carried out to screen for potential problems or side effects before human testing can begin.
2021

Nasal decolonisation: IND-filing/Phase-I/II clinical studies

£10M in Series-A funding provides resources to complete Phase-I and Phase-II human clinical trials to determine efficacy.

Bacterial pneumonia: CMC / Formulation

Chemistry manufacturing control and formulation development begins.
2022

Bacterial pneumonia: Pre-clinical toxicology

Toxicology studies carried out to screen for potential problems or side effects before human testing can begin.
2023

Nasal decolonisation: Phase-III clinical study

Final human studies carried out before licensing for manufacture.

Bacterial pneumonia: IND-filing/Phase-I/II clinical studies

Human clinical trials begin to determine efficacy of an inhaled formulation application in treating bacterial pneumonia infections.

Skin infections: Proof of concept

In vitro and ex vivo studies to determine efficacy in a range of skin infection models including impetigo, acnes and chronic wounds.
2024

Skin infections: IND-filing/Phase-I/II clinical studies

Human clinical trials begin to determine efficacy of topical application in treating skin infections.
2025

Bacterial pneumonia: Phase-III clinical study

Final human studies carried out before licensing for manufacture.

Nasal decolonisation: Sales

Licensing to pharmaceutical companies begins for use in treating MRSA infections: a potential $200M+ market opportunity.
2026

Skin infections: Phase-III clinical study

Final human studies carried out before licensing for manufacture.
2027

Bacterial pneumonia: Sales

Licensing to pharmaceutical companies begins for use in treating bacterial pneumonia; an infection affecting 450M+ people globally and presenting a potential $5B+ market opportunity.

Skin infections: Sales

Licensing to pharmaceutical companies begins for use in treating skin infections (such as impetigo and atopic dermatitis), wound care, medical devices, etc., presenting a potential $10B+ market opportunity.
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