Our current pipeline is focused on finding revolutionary solutions to a number of neurological and psychiatric disorders based on therapeutics derived from the microbiome. High on the list is our ongoing progress made in pilot studies and the phase 1 trial for ALS (amyotropic lateral sclerosis) as well as the concurrent development of its companion diagnostic biomarker.
There is currently no simple blood biomarker to diagnose or to track the progression of ALS. ALS is diagnosed based on clinical examination, motor tests, electrophysiological findings, medical history and the exclusion of confounding disorders. Although the disease is easily recognized in its later stages, it is very difficult to diagnose during its early stages. Due to the need for development of a patient’s symptoms, there is often a diagnostic delay of months to years. The diagnostic process can take between 13 to 18 months or even longer and this delay prevents appropriate treatment from being administered. Unfortunately, by then, the disease can be very debilitating and the brain’s rate of deterioration rapid. There is a higher chance to receive an effective treatment at the early stages of the disease. In fact, the earlier, the better. Currently available therapies have also demonstrated higher efficacy at earlier stages of the disease.
From our human pilot studies, we are seeing some promising results from our proposed blood biomarker’s ability to identify at-risk individuals and those in the early stages of the disease. Pending a bigger sampling size validation, our initial results also show that the biomarker is tracking the efficacy of RaphaLX™ therapy. A discussion with FDA is currently ongoing for it to be considered as a Companion Diagnostic Biomarker in our upcoming clinical Phase 2 trial for ALS.
Our team of researchers and collaborators are actively investigating and developing possible blood diagnostic biomarkers to provide early detection for a number of other central nervous system (CNS) disorders.
In our Pipeline Discovery Phase, some exciting headway is made in therapeutics of early Parkinson's Disease, Peripheral Neuropathy and other conditions .
Summary of our pipeline and clinical timeline with the various milestones