MedLab have revealed that the clinical trials for its Depression drug, NRGBiotic, are progressing ahead of expectations.
MedLab Clinical Ltd (ASX: MDC) made an attention-grabbing announcement today, when it updated the market on the progress of its Phase 2 Depression Trial.
The study is a follow-up to previous trials conducted by the company, which investigated the efficacy of MedLab's formulation versus a placebo—working in conjunction with common anti-depressant medications—as a treatment option for patients diagnosed with treatment-resistant Depression.
This could potentially have huge implications for the future of mental health treatment, as the treatment resistant cohort of Depression sufferers accounts for almost one third of all medicated Depression patients. And luckily for investors, this is also a highly profitable area of the market to target, as it is currently estimated to be worth $15.6 billion, with a 2.4% CAGR.
More importantly, it also acts as an important milestone for the company by validating the potential commercialisation opportunities that drug registration could potentially offer. Following the completion of the trial, the company expects to continue pursuing the drug development pathway, which will involve further product optimisation, and additional clinical research.
"Progression to date has the Board and Research team very excited and optimistic. The study timelines are progressing as planned, and at this point the trial should complete ahead of expectations." MedLab Clinical CEO, Dr Sean Hall
The clinical trial makes use of the company's multi-patented probiotic, NRGBiotic, which is sold as part of MedLab's nutraceuticals range. NRGBiotic is currently available in pharmacies throughout Australia, following a nationwide rollout that commenced earlier this year.
In fact, it has already sold approximately 13,500 units—outside of product reserved for the clinical trial—since patient recruitment began.
The CEO of MedLab Clinical, Dr Sean Hall, explained that the company understands, "this is a much-needed trial for a significant patient group, we further understand Depression is an illness that can have life-long repercussions."
"Patient demand for trial entry exceeded our initial thoughts, and whilst we would ultimately like to help everyone, the trial entry criteria has specific requirements."
"We are looking at, in short, developing a medication that hopefully will address a unique cohort, those over 18 years of age, who have been on anti-depressants, with little to no improvement in symptoms and/or quality of life (QoL). Presently this treatment resistant group accounts for about 1/3rd of all medicated Depression patients," Hall said.
The second phase of the company's clinical trials—which received approval from Australian Human Research Ethics and the Therapeutic Goods Administration—saw an unprecedented expression of interest from potential participants, with more than 1,500 potential candidates eventually being interviewed.
However, due to the strict application criteria, only 90 patients have been selected thus far for participation in the randomised trial.
Preliminary reports from the trial have already highlighted a potentially "efficacious trendline", which may see the trial increase its intake to 130 patients, as a means of further supporting the study's outcomes.
The company expects recruitment for the trial to conclude during the December period—to ensure its current patients are sufficiently monitored—before resuming in mid-January 2020.
News of the trial's latest update has caused MedLab stock to begin climbing in value by 2.70%, which as of midday is currently trading at 0.38 a share.
To learn more about MedLab Clinical visit their Company HQ here.
Disclaimer: Past performance is not an indicator of future performance.
Disclaimer: past performance is not an indicator of future performance
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