4D Pharma was a UK-based pharmaceutical company recognized as a pioneer in Live Biotherapeutics (LBPs). It aimed to develop a new class of medicines to treat a wide range of diseases by harnessing the human gut microbiome. The company focused on identifying specific, single strains of bacteria that could provide therapeutic benefits, moving beyond traditional drug development.
The MicroRx Platform
4D Pharma’s innovation was its proprietary MicroRx platform, a discovery engine designed to identify beneficial bacteria from the gut. Live Biotherapeutics are biological products containing live microorganisms for the prevention or treatment of a disease. Unlike broad-spectrum probiotics, 4D Pharma’s LBPs consist of a single, well-characterized strain of bacteria chosen for a specific therapeutic purpose.
The platform worked by screening a vast library of bacteria isolated from the guts of healthy human donors. MicroRx analyzed these individual strains to understand their specific functions and mechanisms of action. This allowed researchers to pinpoint which bacteria could modulate the immune system, improve gut barrier function, or produce beneficial metabolites relevant to a particular illness.
Promising Clinical Candidates
The MicroRx platform produced a diverse pipeline of clinical candidates. The company’s lead candidate for Irritable Bowel Syndrome (IBS) was Blautix (MRx1234), a single-strain LBP. This candidate completed a Phase II clinical trial for both constipation-predominant (IBS-C) and diarrhea-predominant (IBS-D) forms of the condition. While the study did not meet its primary endpoint, post-hoc analyses showed positive signals in improving symptoms.
In immuno-oncology, 4D Pharma’s candidate MRx0518 showed considerable promise. This LBP was evaluated in multiple Phase I/II clinical trials for its ability to stimulate the immune system to fight solid tumors. It was often studied in combination with checkpoint inhibitors like MSD’s Keytruda, particularly in patients with advanced cancers who had stopped responding to previous immunotherapy. The studies aimed to show that MRx0518 could re-sensitize tumors to treatment.
The company’s research extended to other chronic conditions. For respiratory disease, MRx-4DP0004 was developed for asthma and had successfully completed Part A of a Phase I/II clinical trial, showing it was safe and well-tolerated. 4D Pharma was also advancing into neurology, having received FDA clearance to begin a Phase I trial for two candidates, MRx0005 and MRx0029, for Parkinson’s disease.
The Fall into Administration
Despite its scientific progress, 4D Pharma faced significant financial headwinds. The company struggled to secure the funding required to sustain its extensive and costly clinical trial programs. These difficulties were compounded by challenging market conditions for biotech firms, making it increasingly hard to raise capital.
On June 24, 2022, the company’s primary secured creditor, Oxford Finance LLC, demanded repayment of an outstanding loan facility totaling approximately $13.9 million. Unable to meet this demand or find an alternative funding solution, 4D Pharma’s board placed the company into administration, a form of corporate insolvency. Trading of its shares was suspended on London’s AIM stock exchange, and administrators were appointed to manage the company’s affairs.
Acquisition and Asset Future
After entering administration, US-based investment fund Armistice Capital acquired the secured debt from Oxford Finance. Armistice initially explored a rescue plan that involved converting the debt to equity and providing an additional $15 million in funding. However, this proposed equity raise did not materialize, and by January 2023, Armistice indicated it would no longer fund the group.
With the rescue attempt failing, the administrators sold the company’s assets to recover value for creditors. The company’s intellectual property and research assets were sold to the South Korean firm CJ Bioscience. In a separate transaction, its manufacturing subsidiary in Spain, 4D Pharma León S.L.U., was acquired by Bacthera. This sale ensured that the development of 4D’s LBP candidates could potentially proceed under new ownership.