Tag Archives: MGB Biopharma

Confirmed Safety and Efficacy MGB-BP-3 and Highly Effective in the Target of Reducing C. difficile Recurrence In Promising Phase IIa Study

MGB’s antibacterial avoids infection recurrence cycle in promising phase IIa study

In the trial, 250-mg MGB-BP-3 enteric-coated tablets given twice a day for 10 days cured acute infections and prevented recurrence at eight weeks. That is in contrast to standard of care vancomycin where there is initial cure but the infection recurs in 20% to 30% of cases.

The company points to the ability to prevent recurrent infections as a key differentiator that gives the compound potential to become a first-line treatment.

MGB-BP-3 achieves that effect by rapidly killing vegetative C. difficile in the 10 to 15 hours before it sporulates and lies dormant in the gut.

“We are absolutely delighted to get that effect and to get a very clean safety profile,” said Chris Wardhaugh, chief business officer. “We’ve confirmed we have a compound that is both safe and highly effective in the target of reducing recurrence. There is a surprisingly high mortality from C. diff infections; it’s because the bugs aren’t killed,” he told BioWorld.

Glasgow, U.K.-based MGB Biopharma said the trial demonstrates the 250-mg dose is able to strike the right balance between maximal killing effects, whilst having a minimal effect on the normal gut flora.

That prevents MGB-BP-3 from sparking the usual vicious circle, in which broad-spectrum antibiotic treatment destroys the microbiota, giving resting C. difficile spores an opening to germinate and form vegetative cells that cause a further bout of diarrhea. Each recurrence is associated with increased risk of further recurrence.

The impact on the microbiome is one of the secondary endpoints, but that analysis is not completed yet. “We are still very much going through the data. We only got the safety and efficacy results last week,” Wardhaugh said. “But we’ve shown in previous studies that [MGB-BP-3] kills bacteria so they don’t form spores. We’ve been able to demonstrate in previous studies it is very rapidly bactericidal and wipes out bacteria in the vegetative state.”

It also has been demonstrated MGB-BP-3 is effective against a hypervirulent strain of
C. difficile that is largely resistant to current therapy. That strain accounts for 20% of cases in Europe and 50% in North America.

The cure rate is impressive, but the numbers are small, with only 10 patients in each of three dose cohorts, of which 250 mg was the middle dose. The company has drawn up plans to move straight to phase III, with an interim analysis on the way.

The next step will be to hold a phase II meeting with the FDA, which Wardhaugh suspects will be delayed because of the COVID-19 pandemic. “So we can’t confirm the size of the phase III yet. We did have a post phase I meeting and looked at a number of options. That gave us comfort a single phase III demonstrating superiority over vancomycin, in particular in hypervirulent strains of C. difficile, would be enough for approval,” Wardhaugh said.

“Phase III is really beyond us, so we are looking for partners or investors to take it on. We have it planned out so we can complete clinical development and have started to talk to companies large and small.”

Eligible for incentives

MGB Biopharma has had a hand to mouth existence since it was spun out of Strathclyde University in Glasgow in 2010, to commercialize research of chemistry professor Colin Suckling into compounds that are selective binders of the minor groove of pathogen DNA.

The main backers are Archangel Investors, a syndicate of business angels, and the government-backed Scottish co-investment fund, but the company has not disclosed the value of any rounds of investment. The phase IIa trial, which took place in North America, was funded through a £2.78 million (US$3.4 million) U.K. government grant.

C. difficile infection is recognized as an urgent threat pathogen by the U.S. CDC and MGB-BP-3 has FDA qualified infectious disease product status. That could lead to fast track submission and five years of extra marketing exclusivity.

The product also will be eligible for the prescribing incentives being put in place under the DISARM (Developing an innovative strategy for antimicrobial resistant micro-organism) Act. MGB Biopharma has also talked up the chances of MGB-BP-3 being recommended as first-line treatment in the Infectious Diseases Society of America guidelines, if it makes it through to approval.

The phase IIa dataset has even more resting on it, in that MGB-BP-3 also is active against seven of 21 priority pathogens listed in the GAIN (Generating antibiotic incentives now) Act. Those include the gram-positive infections vancomycin-resistant Staphylococcus aureus and Enterococcus, and gram-negative PseudomonasKlebsiella and Escherichia coli.

MGB Biopharma has developed other formulations of MGB-BP-3, including liquid-filled capsules and a freeze-dried product which is designed to be reconstituted for intravenous administration.

Final formulation optimization and scale up of the intravenous formulation have been completed, as have preclinical proof-of-concept studies against Staphylococcus aureusStreptococcus pyogenes and pneumoniae. There also is a topical formulation for treating MRSA-infected skin lesions in the works.

MGB Biopharma Ltd. is looking for new investors or a commercialization partner to take its lead program, MGB-BP-3, through to market, after reporting 100% initial and sustained cure of Clostridium difficile infections in a phase IIa dose-ranging study.

 

SOURCE:  https://www.bioworld.com/articles/435241-mgbs-antibacterial-avoids-infection-recurrence-cycle-in-promising-phase-iia-study

MGB Biopharma (MGB) Prepares To Launch a Phase II Clinical Trial Of Its Anti-bacterial Agent MGB-BP-3

A new drug aimed at treating potentially deadly Clostridium difficile (C. diff) infections is set to be tested on patients for the first time.

Glasgow-based life sciences firm MGB Biopharma (MGB) said it was preparing to launch a Phase II clinical trial of its anti-bacterial agent MGB-BP-3.

The trial is expected to involve 30 patients based in North America.

All have been diagnosed with C.diff-associated disease (CDAD).

C.diff infections can cause diarrhoea and fever.

They have been a major problem in hospitals around the world, with thousands of deaths in the US alone linked to the bug each year.

The bacteria are able to take over the gut when a course of antibiotics kills off the bugs that normally live there.

MGB’s announcement came after it raised £1.3m from investors for trials of the new drug, which was invented at the University of Strathclyde.

The funding round was led by Edinburgh-based Archangels, with co-funding from a range of sources, including the Scottish Investment Bank, Barwell and Melrose-based Tri Capital.

The cash supplements a £2.7m grant awarded earlier this year by Innovate UK.

SOURCE:  https://www.bbc.com/news/uk-scotland-scotland-business-45508036

MGB said its trial would “evaluate safety and tolerability, efficacy and in particular look for improvement in global (or sustained) cure rates”.

Chief executive Dr Miroslav Ravic said: “We are already witnessing renewed interest in our new anti-bacterial agent and its trial in key medical centres in North America where CDAD is particularly prevalent.

“This offers opportunities both to progress the study rapidly and to attract increased attention to the results for this important trial.”

The company said it was aiming to start the trials in areas of the US and Canada with a high incidence of CDAD early next year.

MGB Biopharma Announced That the US FDA Has Granted Qualified Infectious Disease Product Designation For Treatment Of Clostridium difficile-associated Diarrhea (CDAD)

MGB Biopharma, a biopharmaceutical company developing a novel class of anti-infectives to address the major global problem of antibiotic resistance, announced that the US Food and Drug Administration (FDA) has granted MGB-BP-3, MGB Biopharma’s lead product, Qualified Infectious Disease Product (QIDP) designation for the treatment of Clostridium difficile-associated Diarrhoea (CDAD). The FDA grants QIDP designations to drugs intended to treat serious or life-threatening infections, caused by “qualified pathogens”.

MGB-BP-3 is an antibiotic that has shown to be active against a broad range of important multi-resistant and susceptible Gram-positive pathogens. The oral formulation of MGB-BP-3 is being developed by MGB Biopharma specifically for the treatment of Clostridium difficile, a Gram-positive bacterium responsible for the majority of cases of infectious hospital-acquired diarrhoea in developed countries.

Successful completion of the clinical phase I study of MGB-BP-3 confirmed the compound was well tolerated in healthy volunteers, was not systemically absorbed, had no effect on intestinal permeability, and had a noted effect on the Clostridium class of normal gut flora. MGB is preparing to initiate the phase II clinical study for MGB-BP-3 and investigate the safety and efficacy in patients with CDAD, caused by the most virulent ribotype of C. difficile B1/NAP1/027. This ribotype is shown to cause the highest morbidity and mortality in CDI patients, where the current therapy has only moderate efficacy.

Dr Miroslav Ravic, CEO of MGB Biopharma, said, “We are very pleased with the FDA’s decision to grant QIDP designation to MGB-BP-3 as we believe this drug has the potential to provide a significant benefit in the treatment of Clostridium difficile-associated Diarrhoea (CDAD). Granting of the QIDP designation highlights the potential of MGB-BP-3 to address serious and life-threatening infections and is an important milestone in the development of our lead product, as we prepare to initiate the phase II clinical trial.”

Dr Ravic, added, “Around the world, governments and global organisations are calling for new anti-bacterial drugs and are introducing incentives to reward companies for delivering these products; only last week antimicrobial resistance (AMR) was on the agenda of the G20 Summit. Our MGB-based anti-infectives have the potential to deliver significant advantages over current approaches.”

While pursuing its clinical development activities, MGB Biopharma is now evaluating partnering and funding sources for its lead compound MGB-BP-3, which has the potential to offer a clear differentiated treatment option for patients with life threatening infections caused by resistant and susceptible Clostridium difficile strains.

 

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MGB Biopharma Presented Data In Pre-IND Meeting With FDA With A Proposal For Further Clinical Development Of Oral MGB-BP 3, A Truly Novel Antibiotic Addressing Clostridium difficile (C. diff. )

MGB Biopharma, a biopharmaceutical company developing a truly novel class of anti-infectives to address the major global problem of antibiotic resistance, announces that it has held a pre-Investigational New Drug (pre-IND) meeting with the Food and Drug Administration (FDA) to discuss the regulatory strategy for the development programme of MGB-BP-3 in the US.

MGB Biopharma presented available Phase I and pre-clinical data together with a proposal for the further clinical development of oral MGB-BP-3 in Clostridium difficile infections (CDI). Following this positive meeting, MGB Biopharma are now in the process of obtaining a designation of Qualified Infections Disease Product (QIDP) status for MGB-BP-3, and are starting to prepare for the clinical Phase II study.

MGB-BP-3 is an antibiotic that has shown to be active against a broad range of important multi-resistant and susceptible Gram-positive pathogens. The oral formulation of MGB-BP-3 is being developed by MGB Biopharma specifically for the treatment of Clostridium difficile, a Gram-positive bacterium responsible for the majority of infectious hospital-acquired diarrhoea in developed countries.

Successful completion of the clinical Phase I study confirmed MGB-BP-3 was well tolerated in healthy volunteers, was not systemically absorbed, had no effect on intestinal permeability, and had a noted effect on the Clostridium class of normal gut flora.

Dr Miroslav Ravic, CEO of MGB Biopharma, said: “We are extremely pleased with the support we have received from the FDA with regards to our plans to further progress the clinical development of oral MGB-BP-3. We are now planning to initiate a Phase II clinical trial and investigate the safety and efficacy of MGB-BP-3 in patients with CDI, caused by the most virulent ribotype of C. difficile known as C. difficile B1/NAP1/027. This ribotype is shown to cause the highest morbidity and mortality in CDI patients, where the current therapy has only moderate efficacy.”

Dr Ravic added: “Our discussions with the FDA have provided clear guidelines on the development path we need to take to bring our truly novel antibiotic MGB-BP-3 to market in the shortest possible time. In parallel with our clinical development activities we are now evaluating partnering and funding sources for this exciting opportunity, which we believe will offer a clearly differentiated treatment option for patients with life threatening infections caused by resistant Clostridium difficile.”