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 download a PDF outlining the progress of our developments below.
£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.
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.
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.
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.
