US Patent Office issues Notice of Allowance status for NRGBiotic™ for treating, preventing, or Ameliorating depression or a Depressive disorder.

US Patent Office issues Notice of Allowance status for NRGBiotic™ for treating, preventing, or Ameliorating depression or a Depressive disorder.




US Patent Office issues Notice of Allowance status for NRGBiotic™ for treating, preventing, or Ameliorating depression or a Depressive disorder.

SYDNEY, July 27, 2021 (GLOBE NEWSWIRE) — Medlab Clinical Ltd (ASX.MDC), an Australian biotech using delivery platforms to enhance medicines is very pleased to announce the United States Patent Office (USPTO) has issued a Notice of Allowance for Application number 15/523,271 for the formulation known as NRGBiotic, currently available in Australian Pharmacies.

The Notice of Allowance refers to a USPTO designation that the Patent is allowed to be granted, and Medlab is expecting this pending formality should occur within the next 3 to 4 months.

For context, The World Health Organization (WHO) in January 2020 stated, Depression is a leading cause of disability worldwide with more than 264 million people suffering from Depression.1 With close to 800,000 deaths associated annually, overall, costing approximately US$1 trillion per year in lost productivity.2

In today’s environment and somewhat exaggerated by the COVID-19 related issues, Australian peer group, Beyond Blue estimates 3,000,000 Australians live with Depression, over 10% of the Australian population and is reflected globally.

The patent covers both the formulation of NRGBiotic and a method for treating, preventing, or ameliorating at least one symptom of depression or a depressive disorder and is valid through to 28 October 2035. 

Dr Sean Hall, CEO of Medlab stated “the USPTO decision to allow is welcoming news. NRGBiotic has both the formulation and capabilities of that formulation previously approved in Australia. Receiving this notification off the back of successful trial outcomes (announced on 5 July 2021) attests to the robust work Medlab undertakes. From a commercial aspect, NRGBiotic is a branded line here in Australia, and will now go to our partnering network in the Northern Hemisphere.”

On 5 July 2021, Medlab announced the NRGBiotic Depression Trial conducted at Queensland University of Technology (QUT) under Australian Clinical Trial Research Number ACTRN12617000419369 / HREC Approval: 2017000186, NRGBiotic MET 4 of the 5 endpoints:

The Primary Outcomes (2/2 MET) were:

  1. MET – Participants taking both NRGBiotic, and an anti-depressant had greater symptom remission over the 8 weeks period than those on an anti-depressant alone (p=0.015)*.
  2. MET – Incidence of dysbiosis assessed by faecal analysis showed both groups were dysbiotic, holding to the premise that anti-depressant medications adversely affect the intestinal bacteria leading to an unbalanced dysbiotic gut.

The Secondary Outcomes (2/3 MET) were:

  1. MET – Participants taking both NRGBiotic and an anti-depressant had greater proportional increase in Quality of Life (QoL) Scale from baseline to 8 weeks, than those on anti-depressants alone (p=0.015).
  2. MET – Participants taking both NRGBiotic and an anti-depressant had greater improvement in non-clinical levels of symptoms (e.g., interpersonal, social, etc) than those on anti-depressant medications alone (p=0.003).
  3. NOT MET – Proportion of participants with a reduction in lipopolysaccharides (LPS) showed no noticeable differences between the groups.

* The lower the p-value, the greater the statistical significance of the observed difference, for example, a p-value of 0.0254 is 2.54%. This means there is a 2.54% chance your results could be random (i.e., happened by chance).

About Depression

Depression is classified as a mood disorder. It may be described as feelings of sadness, loss, or anger that interfere with a person’s everyday activities.3 Depression can be mild, moderate, or debilitating. Conditions known to worsen due to depression include Arthritis, Asthma, Cardiovascular Disease, Cancer, Diabetes and Obesity.

Authorisation & Additional information

This announcement was authorised by the Board of Directors of Medlab Clinical Limited.

About Medlab Clinical:

Medlab Clinical LTD (ASX:MDC) is pioneering the development and Commercialisation of a delivery platform, allowing for enhanced medical properties, including increased efficacy, safety, patient compliance and stability. Medlab’s pipeline comprises a number of small and large molecules from repurposing generic medicines to enhancing the delivery of immunotherapies. Patented lead drug candidate NanaBis has been developed for cancer bone pain as a viable alternative to opioid use. Data to date, strongly suggests NanaBis may be equally effective in non-cancer neuropathic pain. NanoCelle®, the patented delivery platform is wholly owned by Medlab and developed in Medlab’s owned OGTR Registered Laboratory. NanoCelle® is designed to address known medication problems, addressing global unmet medical needs. Medlab operates in Australia (Head Office), USA, and the UK.
For more information, please visit www.medlab.co

Medlabbetter medicines, better patient care

Contact:

Medlab Clinical
Dr. Sean Hall, CEO
Sean_hall@medlab.co
Medlab US Investor Relations
Laine Yonker
lyonker@edisongroup.com

1 https://www.who.int/news-room/fact-sheets/detail/depression
2 https://www.who.int/teams/mental-health-and-substance-use/mental-health-in-the-workplace
3 https://www.healthline.com/health/depression