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 initiated to screen for potential problems or side effects before human testing can begin.
2020

AI-discovery pipeline: R&D

Studies begin using the ‘deep-fake’ AL algorithm to search for new drug candidates from the epidermicin family.
2021

Skin infections: Proof of concept

In vitro and ex vivo studies to conducted indicate the relevance of epidermicin NI01 in a range of skin infections including impetigo, acnes and chronic wounds. NI01 does not have toxic effects on the immune system in ex-vivo skin, which differentiates it from similar drug candidates.
2022

Nasal decolonisation: Successful Pre-clinical toxicology findings

Epidermicin formulated for delivery to the nose and pre-clinical safety and tolerability studies conducted with no adverse effects seen at the highest doses used.

Bacterial pneumonia: Early-stage R&D

Research commences to examine the feasibility of using epidermicin NI01 to treat bacterial pneumonia with promising data in laboratory assays.

AI-discovery pipeline: R&D

Testing begins for antibiotic candidates from the AI-discovery pipeline.
2023

AI-discovery pipeline: R&D

In late-2023, proof of concept studies will begin with any promising antibiotic candidates from the AI-discovery pipeline.

Bloodstream infections: Early-stage R&D

To investigate the potential for using epidermicin NI01 to treat Staph/Strep bloodstream infections, a preliminary IV study will be carried out.
2024

Skin infections: Pre-clinical efficacy & toxicology

Infection model efficacy and pre-clinical safety studies initiated to screen for potential problems or side effects before human testing can begin.

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

£2.5M in Seed funding provides resources to complete Phase-I and Phase-II human clinical trials to determine efficacy.

Bacterial pneumonia: Pre-clinical toxicology

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

AI-discovery pipeline: Pre-clinical toxicology

Pre-clinical efficacy and safety studies with leading candidates in their selected clinical indications.
2025

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

£5M Series-A funding completed to start human clinical trials to determine efficacy of topical application in treating skin infections.

AI-discovery pipeline: IND-filing/Phase-I/II clinical studies

Target indications will be selected for the lead AI candidates and human clinical trials will start to determine efficacy and safety in those target infections.
2026

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.

Nasal decolonisation: License deal closed

Licensing to pharmaceutical companies begins for use in treating MRSA infections: a potential $200M+ market opportunity.
2027

Bacterial pneumonia: License deal closed

Licensing to pharmaceutical companies begins for use in treating Staph/Strep Community Acquired Pneumonia (CAP): an infection affecting 450M+ people globally and presenting a potential $5B+ market opportunity.
2028

Nasal decolonisation: Phase-III clinical study completed

Successful Phase-III studies enable marketing and launch of epidermicin NI01.

Skin infections: Phase-III clinical study

Final human studies carried out before licensing for manufacture.
2029

Bacterial pneumonia: Phase-III clinical study

Final human studies carried out before licensing for manufacture.
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