Current results are suggesting the trial will complete earlier than originally required.
The impact of the trials progressing ahead of expectations marks an important milestone to expanded commercialisation opportunities that drug registration would offer.
Adjunct to depression treatment
Trials focus on an adjunct to depression treatment which is globally estimated to be a $US864 million market in 2015 and is expected to reach $US1.2 billion by 2024.
Overall, the global depression market is estimated to be $US15.6 billion, at 2.4% CAGR.
The plan for NRGBiotic™ is to follow a drug development pathway, whereby after this trial, Medlab would expect results publication, product optimisation and further trial work.
Medlab plans at the end of this trial to continue talks with the TGA for drug pathway development which would be critical for future NRGBiotic™ plans.
Team “very excited”
Medlab CEO Dr Sean Hall said, “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.”
Shares have been up as much as 4% in early trade to 38.5 cents.
In July 2018 Medlab announced the start of recruitment for an Australian Human Research Ethics and TGA approved Clinical Trial.
It is an n=150 study to follow on from previous trials investigating the use of NRGBiotic™ versus placebo as an adjuvant to SSRI and or SNRI, which are common anti-depressant medications, for people diagnosed with depression that were getting little or no relief from standard medical treatment for major depression.
Strict inclusion criteria
Progression of the Phase 2 trial to date with principal investigators Dr Esben Strodl and Dr Matthew Bambling at Queensland University of Technology, Brisbane, has seen about 1,500 potential candidates interviewed.
However, due to the strict inclusion criteria, to date 90 patients have been randomised and entered into the study.
Medlab CEO Dr Sean Hall said, “We understand 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.”
NRGBiotic™ is a multi-patented probiotic available throughout Australian pharmacies as part of the national rollout that began in the first half of 2019.
Since the trial recruitment announcement there have been approximately 13,500 units sold to Australians outside the trial cohort.
Hall said, “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.
“Presently this treatment-resistant group accounts for about one-third of all medicated depression patients.”
Potential efficacious trendline
While trial participants and researchers are blinded to the active or placebo treatment, preliminary reports highlight a potential efficacious trendline that may see the trial complete at 130 patients to report against statistically relevant powering to support the study outcomes.
As the Christmas season approaches, recruitment for the study will stop to ensure those patients under investigation are sufficiently monitored, with recruitment expected to recommence in mid-January 2020.
Hall said, “Depression is a global epidemic, affecting just over 5% of the world’s population, scarier though, health authorities are expecting this to rise to 7% within the immediate foreseeable future, resulting in a growing global patient group where medication strategies potentially will only work on two-thirds of the patient group.
“We, (Medlab) believe we can offer novel, replicable and reliable intervention strategies that will reduce symptoms and improve quality of life.”