Anti-infective drugs from DNA Minor Groove Binders from bench to bedside

Who's involved?

Strathclyde Institute of Pharmacy & Biomedical Sciences

Department of Pure & Applied Chemistry

The research

Following the discovery of a range of anti-infective minor groove binders for DNA (patent application 2006, publication 2007) a commercial partnership was established between Strathclyde and a new Scottish company, MGB Biopharma, for the development of the University of Strathclyde IP through clinical trials to the market. The first of the compounds to be developed, MGB-BP-3 has now successfully completed Phase 1 clinical trials for the treatment of Clostridium difficile infections. MGB is ready to commence a Phase II study of MGB-BP-3’s oral formulation. The FDA has signalled support for Phase II and a single Phase III superiority study protocol. The project has been awarded GAIN (Generating Antibiotics Incentives Now) Status by the FDA. The FDA approved a single pivotal Phase III study demonstrating superiority against vancomycin in SCR to expedite development. The company are currently seeking investment to initiate the Phase II trial.

MGB-BP-3 is also being developed for other infections in intravenous and topical formulations that will result in further products going into clinical trials.The UoS is also the hub for the discovery of MGBs to treat other challenging bacterial infections including MRSA and tuberculosis and also parasitic diseases. Compounds are effective in-vitro against tuberculosis. Success has been achieved in a mouse model of African animal trypanosomiasis.

How we achieved bench to bedside research with a commercial partner

Following the discovery of a number of very active antibacterial compounds and the submission of patent applications (now granted), we sought a commercial partner for the development. After a substantial search led by our Research & Knowledge Exchange Services team, a licence was granted to Pharma Integra which was able to raise funds to establish a new, Scottish-based company, MGB Biopharma.

MGB Biopharma began operations in 2010. It's funded by a syndicate of some of Scotland’s leading business angels, in co-operation with Scottish Enterprise. The MGB Biopharma and Strathclyde partnership is concerned with discovering and developing new anti-infective drugs, in particular antibacterial drugs based upon Strathclyde’s IP.

MGB Biopharma undertakes the development of clinical candidate molecules selected from the Strathclyde collection. So far, one compound, MGB-BP-3, is in clinical development for the oral treatment of Clostridium difficile infections (CDI); it has successfully completed an integrated SAD and MAD Phase I clinical trial. The company is also developing an intravenous formulation of the same compound for the treatment of systemic Gram-positive infections, such as MRSA; this formulation is currently at the late pre-clinical stage. Furthermore, the completion of a topical feasibility study with MGB-BP-3 has highlighted another route of development to combat serious Gram-positive skin infections. MGB Biopharma is on track to be the first developer of a truly novel antibacterial for more than a decade, and is a beneficiary of the GAIN initiative in the US. 

There is a pipeline of antibacterial compounds being developed by MGB Biopharma in partnership with the University of Strathclyde, including those with activity against Gram-negative bacteria, viruses, parasites and fungi. There has been active scientific exchange of information between Strathclyde and MGB Biopharma throughout the partnership, and this relationship continues to thrive.

In a seriously challenging financial environment, MGB Biopharma has raised £5.5M commercial funding from investment syndicates and over £1.4M from public funds. Strathclyde has raised approximately £1M from public and private funds (including RCUK) to support the underlying basic science. There is evidence of international interest in many of these projects based on the interest from large international pharma companies, life science VCs and international funding syndicates such as ENABLE (ND4BB).