MGB Biopharma is developing a pipeline of antimicrobials to tackle antimicrobial resistance.
“MGB Biopharma has made excellent progress across all areas of the business in 2014,” said Dr Miroslav Ravic, MGB Biopharma’s CEO.
“We secured £4 million, including a £1.3 million funding award from the Biomedical Catalyst programme in September 2014 to advance our novel antibiotic candidate MGB-BP-3. The equity funding, from a syndicate of Scotland’s leading investors, clearly highlights their ongoing commitment to our business and to our unique approach to develop differentiated antibacterials.
We concluded significant manufacturing agreements with Almac and Encap for the supply of our forthcoming trials with MGB-BP-3. As a result, we remain on track to start Phase I trials with the oral formulation of MGB-BP-3 for C.difficile in the first half of 2015 and expect the preclinical I.V. formulation for hospital-acquired Gram-positive infections to be IND-ready by the end of 2015.
“With our truly novel anti-infective candidates that have a unique mode of action and a broad platform, we are well positioned to address the global call for better anti-infectives that can help solve the major problem of resistance. We believe 2015 will be a pivotal year for the Company and the progress of MGB-BP-3 as we deliver important milestones that will significantly increase the value of our business.”
In September 2014, MGB Biopharma secured £4 million ($6.4M) for the further development of its novel lead antibiotic candidate MGB-BP-3. MGB-BP-3 is being developed against a range of Gram-positive infections including C. difficile (oral) and resistant and susceptible Staphylococcus and Streptococcus species (I.V.). MGB-BP-3 is the first antibacterial for over a decade with a novel mode of action from a truly novel class to be developed globally.
£2.7m of this funding came from a syndicate of investors, led by Archangels, and includes existing investors Barwell PLC, TRI Cap and the Scottish Investment Bank, the investment arm of Scottish Enterprise. In addition, MGB Biopharma was the recipient of a prestigious £1.3m funding award announced in June by Innovate UK, formerly the Technology Strategy Board (TSB), under its Biomedical Catalyst programme.
The group has made progress in finalising preparations for the Phase I trial for the oral formulation of lead candidate MGB-BP-3 for the treatment of C. difficile infections. In December 2014 MGB concluded manufacturing agreements with Almac Group Ltd and Encap Drug Delivery to manufacture and fill and coat the MGB-BP-3 API respectively. These companies will supply MGB-BP-3 for upcoming clinical trials.
The Phase I trial is on track to start in the first half of 2015. Approximately 40 healthy subjects are expected to be enrolled into the single centre, double-blind, placebo controlled trial to determine the safety and tolerability of single and multiple ascending doses of oral MGB-BP-3. The trial will also examine the effect of MGB-BP-3 on normal gut flora.
The group says it also expects to complete the preclinical development of an injectable formulation of its lead product MGB-BP-3 by the end of 2015. The I.V. formulation will target major hospital-acquired Gram positive infections caused by Methicillin Resistant Staphylococcus aureus (MRSA), Vancomycin Resistant Enteroccoci (VRE) and Streptococci.
In June 2014, Dr Stephanie Dancer, an internationally renowned medical microbiologist, joined MGB Biopharma’s scientific advisory board (SAB) to help oversee the development of MGB-BP-3.
Dr Dancer is currently a medical microbiologist in NHS Lanarkshire and has been editing the Journal of Hospital Infection for 18 years, five of which as editor-in-chief. Her current research focuses on the role of antibiotics, screening and cleaning in the control of Methicillin-resistant Staphylococcus aureus (MRSA) and other hospital pathogens.