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Pipeline

NM002

NM002 is a unique immunomodulator-antimicrobial that could bring about a paradigm shift in the treatment of inflammatory-infectious disease.

NM002 is a small molecule (aminothiol) derived from the innate immune defense response. It has the potential to resolve (hyper)inflammation as well as the infectious cause of that inflammation. 

Respiratory disease

NM002’s unique combination of immunomodulatory (anti-inflammatory) and antimicrobial (antiviral and antibacterial) properties position this therapy candidate as a potential game-changer in inflammatory-infectious respiratory and other diseases.  NM002 is currently being on-boarded to a major international platform (phase 3) clinical study for community acquired pneumonia (including COVID19) in an ICU setting.

Novabiotics for medically unmet diseases

Antimicrobial resistance

NM002 is a potential solution to the worsening, global antibiotic resistance crisis. NM002 is an antibiotic potentiator/resistance breaking agent to a number of antibiotic classes; potentially extending their utility and scope against drug resistant, even MDR and XDR bacterial infections. Put simply, NM002 ‘supercharges’ existing antibiotics, especially against drug resistant bacteria and has potential utility that extends significantly beyond respiratory infections.

NP339 for Respiratory Fungal Disease

For respiratory fungal infections.

 

Fungal infections of the airways are an increasing clinical challenge and negatively impact outcomes in a number of patients with complex respiratory disease.

NP339 is an antifungal peptide with activity against Aspergillus spp. Scedosporium spp., Exophiala spp. and other pathogens of relevance to respiratory disease and is being developed in inhaled form for chronic and acute treatment of respiratory fungal infections.  The physicochemical properties of NP339 are ideally suited for direct delivery into the lungs and in simulations of respiratory Aspergillus fumigatus infection, we have already demonstrated that inhaled NP339 is effective in killing Aspergillus within lung tissue [see ECCMID poster here].

 

NP213 (Novexatin)

The first fungal nail therapy to rapidly address the infection and improve nail appearance in fungal nail infection

NP213 is a novel, synthetic peptide generated from NovaBiotics’ proprietary technology platform.

Clinical studies have demonstrated that a brush-on formulation containing NP213 is safe, well-tolerated and effective in resolving mild to moderate toenail infection following just one month of once daily application.  Currently available topical treatments require up to 52 weeks of treatment.  NP213 based treatments are the first solutions for fungal nail infection to address both the underlying cause of the condition and the cosmetic issues associated with the infection.  In clinical studies, patients and physicians reported an improvement in affected nails after only 11 days of once-daily NP213 application and >50% of patients‘ nails were clear (by culture test) of fungi 1 year on following 28 days of application of an NP213 based solution.

 

NP213 replicates the natural defences of the healthy nail, creating an environment that doesn’t support fungal growth and prevents re-infection.  The peptide remains active within the nail as it grows out, maintaining an environment that doesn’t support fungal growth and prevents re-infection beyond the period of product application.  NP213 is based on natural, catabolic nail/dermal peptides but is a more potent, synthetic fungal membrane lysing peptide.  The mechanism of action of NP213 is physical kill via fungal membrane disruption and rapid lysing on contact.

Global Market

clinical-stage biotechnology company

Onychomycosis affects an estimated 12% of the world’s population and therefore represents a significant market.  There are a number of environmental and medical risk factors associated with this condition including physical insult to the nail, poor circulation, compromised immunity and diabetes; onychomycosis being a major comorbidity – along with foot ulcers – for type II diabetes.  Fungal nail infection has a higher prevalence in the elderly which, against a background of an ageing population means that the overall frequency of fungal nail infections will increase over time.  Importantly onychomycosis is not merely a cosmetic condition; it also impacts the quality of life of those affected.  Current treatments are either ineffective or associated with adverse effects and the market is poised for rapid uptake of a novel treatment with the unique and highly differentiated features of NP213.

NP432

A novel strategy to combatting drug-resistant bacterial infections

NP432 has been derived from a platform of antibacterial peptide therapy candidates.  These bactericidal agents have a number of key benefits over conventional antibiotic therapies and the clear potential to succeed where existing treatments for a number of bacterial infections, including drug resistant MDR and XDR infections are failing.

NP432 and our family of antibacterial peptides are derived from same technology platform as NP213 (Novexatin) and NP339 and so the route to clinic anticipated for this novel antibacterial therapy candidate has already been significantly de-risked.

NP432 is NovaBiotics’ preclinical stage lead antibacterial peptide asset and along with its family of related peptides is broad-spectrum, potently and rapidly bactericidal in vitro against clinically and economically important bacteria. NP432 is active against bacteria identified by the World Health Organisation as Priority Pathogens including Pseudomonas aeruginosa, Clostridium difficile, Acinetobacter baumannii and Klebsiella pnuemoniae. NP432 and its related family of antibacterial peptides are active against drug resistant and multi drug resistant bacteria. NP324 has shown to be well-tolerated and has demonstrated efficacy in in vivo infection models.

NP432’s unique therapeutic mechanism of action is rapid bacterial membrane perturbation and lysis leading to bacterial death (not merely inhibiting growth). Importantly, this mechanism of action also means that NP432 does not interact with human cells and that is possesses no or a very low risk of acquired resistance developing in the bacteria it targets compared to conventional antibiotics.

Global Market

Bacterial infectious diseases represent a massive unmet medical need globally.  The worldwide market for antibacterials is considerable at $45 billion; more than 50% of the overall anti-infectives market at $65 billion.  Despite this significant global opportunity, the sector remains dominated by a relatively small number of drug classes, some having existed in clinical practice for over 50 years.  R&D efforts are also focused on re-invigorating these existing/older drug classes versus the creation of new classes, typically via new formulations to secure IP, rather than launch of new compounds.

NovaBiotics is pioneering anti-infective peptide drug discovery and development for bacterial disease and is targeting difficult-to-treat, potentially life-threatening infections with its Novarifyn technology.  Uniquely, Novarifyn effectively kills antibiotic sensitive and resistant bacteria both in planktonic (“free”) form and in more challenging biofilm infections (biofilms serve as a means of protection for bacteria against the immune system and antibiotic therapies and are the main reason why many infections remain insensitive to conventional antibiotics).