4D Pharma receives FDA approval on investigational new drug (IND) applications for two Live Biotherapeutics (LBPs), MRx0005 and MRx0029.
4D Pharma focuses on Live Biotherapeutic products (LBPs) which are derived from microbiomes. The LBPs are in development for the treatment of Parkinson’s disease.
With the approval from the FDA, 4D underway to begin first-in-human Phase 1 clinical trials in patients diagnosed with Parkinson’s disease by mid-2022.
More than 10 million people globally suffer from Parkinson’s disease.
“Current treatments focus on symptoms but do not address the underlying causes of neurodegeneration. Patients and clinicians are in need of new, more effective treatment options, and the gut-brain axis is an exciting area of innovation with the potential to change the way we approach Parkinson’s treatment. We believe that our LBPs MRx0005 and MRx0029, which each have different mechanisms of action worthy of investigation, provide a unique opportunity to address the high unmet needs of those living with Parkinson’s disease,” said Dr. Alex Stevenson, Chief Scientific Officer, 4D Pharma.
“Oral, gut-targeted treatments such as 4D pharma’s Live Biotherapeutics MRx0005 and MRx0029 offer an exciting new way for possibly slowing Parkinson’s disease progression. The development of these potential new therapies is really breaking new ground in the field,” said Professor Peter LeWitt, Sastry Foundation Endowed Chair in Neurology at Wayne State University School of Medicine, and Coordinating Investigator of the Phase I clinical trial.
4D Pharma enabled a microbiome profiling platform known as MicroDx which allows them to understand the correct treatment and diagnosis with their LBPs. Live Biotherapeutic products is disruptive medicine which understand the workings of the bacteria found in your gut interact with the rest of your body. With MicroRx, 4D Pharma can select the gut bacteria which would have a therapeutic effect on certain diseases.
With the use of MicroRx, 4D Pharma was able to cater to various therapeutic areas including immuno-oncology, GI, respiratory, autoimmune and CNS disease, using their development programs.
4D Pharma’s Parkinson’s treatment is one of a number of pipeline treatments that includes oncology and respiratory drugs.
A quick look at their pipeline:
Immuno-oncology
MRx0518 have all reached various phases of in-human trials. The MRx1299 is still in development.
CNS
In neurodegeneration, MRx0029 & MRx0005 are in development whereas, Psychiatric disorders to be treated by MRx0006 is still in the preclinical stage.
Respiratory
MRx4DP0004 used to treat asthma is nearing the end of Phase 1 trials.
Gastro-intestinal medicines are also progressing in-human trials beyond Phase 1. However, autoimmune treatments are still in development.
4D Pharma shares spiked high on the open and drifted to 2.92% at 31.39p mid day on Tuesday.
“We’re looking to push the boundaries of microbiome therapeutics further,” says Duncan Peyton, the co-founder and CEO of 4D Pharma, said in an interview with Genetic Engineering & Biotechnology News.