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2022-03-16|

4D Pharma Cleared to Investigate Healing the Brain through the Gut

by Eduardo Longoria
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The FDA has approved UK-based 4D Pharma’s investigational new drug applications for two drugs; MRx0005 and MRx0029. The pair are both meant to treat Parkinson’s disease by making use of treatments known as Live Biotherapies and will be in their first-in-human Phase 1 clinical trial in Parkinson’s disease sufferers in mid-2022. 

 

Live Biotherapies (LBPs)

 

These novel treatments are, according to the FDA, living strains of a microorganism (usually a symbiont with the human body) to treat an illness that is also not vaccines.

These kinds of treatments are particularly advantageous in Parkinson’s as it is suspected that impaired intestinal barrier function and intestinal permeability are common symptoms of Parkinson’s disease thought to potentially contribute to the onset or progression of the condition.

These treatments have the distinct advantage of being much safer than other Parkinson’s treatments as these strains of bacteria are all native to the human gut and won’t have the same risk of side effects as other medications would.

    

4D Pharma Innovations 

  

These LBPs were found using 4D Pharma’s MicroRx® platform. The platform works by isolating microbes from fecal samples using selective media and culturing methods. Once this is done the bacteria have their genome sequenced and function tested for their immunological interactions with the gut for both mechanisms and efficacy.

The company seized the opportunity left by the lack of approved disease-modifying treatments which prevent, slow or reverse the underlying neurodegenerative processes.

Along with its work with Parkinson’s 4D Pharma has clinical programs dealing with asthma, cancer and irritable bowel syndrome.

 MRx0005 and MRx0029 have been shown pre-clinically to have positive impacts on multiple key aspects of Parkinson’s disease pathology, including gut barrier integrity, neuroinflammation, oxidative stress and neuroprotection. In animal models of Parkinsonian syndrome, 4D Pharma demonstrated that MRx0005 and MRx0029, respectively protected against the loss of dopamine metabolites and dopamine-producing neurons in the brain.

 

Parkinson’s Impacts and Treatment Benefits

 

The second most common age-related neurodegenerative disorder, Parkinson’s affects an estimated ten million people worldwide. While motor symptoms such as tremors are a common hallmark of the disease there are many non-motor symptoms, such as constipation, that often precede the onset of motor symptoms by years.

Parkinsons’ often begins neurological symptoms around age 60 and has a deleterious effect on the sufferer as well as their family. To care for a person with this illness, it costs approximately $21,000 dollars per year when lost wages are accounted for. 

 

Company Outlook

 

4d pharma IPO’d on Mar 22, 2021, and has had a total of two financing rounds and taken on debt post IPO. Since the revelation of this MRx0005 and MRx0029 its stock price has remained relatively unaffected until March 14th when it hit a local maxima. This spike, while locally encouraging is part of an overall downward trend that has been going on since 2021. Despite the tepid response from the market being able to treat Parkinson’s early and through more than just the replacement of dopamine via L-Dopa supplements can avoid years of suffering and perhaps even prevent the onset of serious symptoms in potential Parkinson’s patients.  A company that is able to produce such a treatment and at such a low R&D burden as making use of naturally occurring bacteria has a lot of profit potential in the biotech space.

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