The trial closed at 120 patients and aimed to follow-on from previous trials investigating the use of NRGBiotic™ versus placebo as an adjuvant (used with) to a selective serotonin reuptake inhibitor (SSRI) and or serotonin-norepinephrine reuptake inhibitor (SNRI) which are common anti-depressant medications for people diagnosed with depression.
Shares in the company closed at 22 cents, up from 13.5 cents on March 27.
Medlab chief executive officer Dr Sean Hall said: “Personally, in light of the COVID impact, I am very pleased we have been able to fulfil our research duties with minimal interference to participants, and whilst the intervention stage is completed, the trial cohort will for the next three months focus on testing outcomes and an independent analysis of those results.”
Medlab has indicated that completion of this trial, whilst retaining its statistical relevance, is a key driver for the business moving forward in managing the company’s exposure to COVID and any potential economic impact.
Medlab director of medical research Professor Luis Vitetta said: “The completion of a randomised placebo-controlled study with patients diagnosed with major depression unresponsive to standard pharmaceutical medications is a significant milestone achievement for Medlab’s research group.”
Vitetta said: “We look forward to the independent analysis of the data that will provide important links between the gut bacteria cohort, blood metabolites and mood; and the level of treatment efficacy achieved for depression with a Medlab patented formulation.”
Pathology and an independent review is expected in three months.
Depression treatment market
The trial focused on an adjunct to depression treatment, which was globally estimated to be a US$864 million market in 2015 and is expected to reach US$1.2 billion by 2024.
Overall, the global depression market is estimated to be US$15.6 billion at a 2.4% compound annual growth rate.
The impact of the trials progressing ahead of expectations marks an important milestone to expanded commercialisation opportunities that drug registration would offer.
Medlab expects that results publication and doctor/pharmacist education, as well as undertaking heightened dialogue with the Therapeutic Goods Administration, will determine the next potential steps.