REG - Seed Innovations Ltd - Investee Company Update: Little Green Pharma Ltd

Seed InnovationsAnnouncement

15/02/2023 11:00

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20230215:nRSO0236Qa&default-theme=true

RNS Number : 0236Q  Seed Innovations Limited  15 February 2023

15 February 2023

 

SEED Innovations Limited

("SEED" or the "Company")

Investee Company Update: Little Green Pharma Ltd

 

SEED Innovations Ltd, the AIM-quoted company investing in fast-growing and
industry-leading businesses with a focus on the medical cannabis, health, and
wellness space, is pleased to note an announcement released on the ASX by its
portfolio company, Little Green Pharma Ltd ('LGP').

The Company owns 7,324,796 ordinary shares in LGP representing 2.8% of LGP's
issued share capital.

The following extract from the announcement is set out without material
changes or adjustments and the announcement in full can be accessed from the
following
link: https://investor.littlegreenpharma.com/site/investor-centre/asx-announcements
(https://investor.littlegreenpharma.com/site/investor-centre/asx-announcements)

 

Ethics approval granted for psilocybin clinical trial

 

Highlights:

·    Reset Mind Sciences receives ethics approval to conduct clinical
trial into efficacy and safety of psilocybin assisted therapy involving family
members for patients with treatment resistant major depressive disorder

·    Trial focused on development and refinement of best practice
psychotherapy protocols to accompany administration of psilocybin

·    Trial to be sponsored by Reset Mind Sciences with leading academic
and consultant psychiatrist Professor Sean Hood (University of Western
Australia) as Principal Investigator

·    Recruitment expected to commence in the second quarter of 2023 with
the trial expected to take approximately 12 months to complete

·    Trial takes on heightened relevance and significance following the
TGA's recent decision to down-schedule psilocybin in defined circumstances for
use with treatment resistant depression

 

little Green Pharma Ltd (ASX: LGP, "LGP" or the "Company") is pleased to
announce its wholly owned subsidiary and operator of LGP's psychedelics
business, Reset Mind Sciences Limited ("Reset") has received Human Research
Ethics Committee ("HREC") approval to conduct its proposed twelve-month,
single-centre, randomised, open-label, parallel group (2-arm), superiority
clinical trial ("Clinical Trial" or "Trial") into the efficacy and safety of
psilocybin-assisted psychotherapy ("PAP") involving family members compared to
standard PAP for adults with treatment resistant major depressive disorder.
The grant of the HREC approval for the Clinical Trial is the result of a more
than 18-month development and approval process in cooperation with key
clinical trial personnel from University of Western Australia and Edith Cowan
University.

 

The Clinical Trial builds on the increasing body of research globally into the
use of psilocybin to treat depressive related conditions by incorporating key
family members into the preparatory and integration therapy sessions that
precede and follow the psilocybin administration sessions. The Trial has taken
on added significance and relevance given the TGA's announcement on 3 February
2023 that it had changed the classification of psilocybin within certain
defined parameters for the treatment of Treatment Resistant Depression from 1
July 2023. A copy of the media release is available here:
https://www.tga.gov.au/news/media-releases/changeclassification-psilocybin-and-mdma-enable-prescribing-authorised-psychiatrists
(https://www.tga.gov.au/news/media-releases/changeclassification-psilocybin-and-mdma-enable-prescribing-authorised-psychiatrists)
 

 

The Trial allows Reset to test and refine best practice psychotherapy
protocols to accompany administration of psilocybin to trial participants.
Recruitment for the Trial is anticipated to commence in the second quarter of
2023 with the trial expected to run for approximately 12 months.  The trial
will include 60 participants and will be conducted at the Harry Perkins
Institute of Medical Research in Perth, Western Australia in conjunction with
Fiona Stanley Hospital. It is expected to be the first clinical trial to be
conducted in Western Australia using psilocybin.

 

Reset Mind Sciences Chief Executive Officer, Shaun Duffy, commented: "We're
focused on testing and refining psychotherapy protocols and developing a
network of clinicians with real world experience in the administration of
psychedelic assisted psychotherapy. They're our primary objectives here and we
believe the work has taken on even more importance in the wake of the recent
decision by the TGA.

"The trial will be one of the first psilocybin assisted therapy trials in
Australia and we trust it will contribute meaningfully to the clinical
evidence supporting the use of psilocybin and other psychedelics for the
treatment of chronic mental illness in Australia.

 "Given we are investigating the condition allowed by the TGA for
prescription of psilocybin from 1 July 2023, we anticipate the clinical
evidence we obtain will be highly instructive in the treatment of patients
under the new regime announced by the TGA."

 

 

- Ends -

For further information on the Company please visit:  www.seedinnovations.co
(http://www.seedinnovations.com/)    or contact:

 

 Ed McDermott       SEED Innovations Ltd         E: info@seedinnovations.co

 Lance de Jersey
 James Biddle       Beaumont Cornish Limited,    T: (0)20 7628 3396

 Roland Cornish     Nomad
 Isabella Pierre    Shard Capital Partners LLP   T: (0)20 7186 9927

 Damon Heath        Broker
 Catherine Leftley  St Brides Partners Ltd,      E: info@stbridespartners.co.uk

 Isabelle Morris    Financial PR

 Max Bennett

 

 

Notes

Seed Innovations Ltd

SEED Innovations is an AIM quoted investment company focused primarily on
disruptive high growth life sciences and technology businesses particularly
within the medical cannabis arena. The Company's strategy is to identify
early-stage opportunities that have an upcoming investment catalyst and grow
its portfolio in terms of value whilst limiting the number of investee
companies to a level where relevant time can be devoted to each.

About Little Green Pharma

Little Green Pharma is a global, vertically integrated and geographically
diverse medicinal cannabis business with operations from cultivation and
production through to manufacturing and distribution.

The Company has two global production sites for the manufacture of its
own-branded and white-label ranges of GMP-grade medicinal cannabis products,
being a 21,500m2 cultivation and 4,000m2 GMP manufacturing facility capable of
producing over 30 tonnes of medicinal cannabis biomass per annum located in
Denmark (EU) and an indoor cultivation and manufacturing facility located in
Western Australia capable of producing ~3 tonnes of medicinal cannabis biomass
per annum.

Little Green Pharma products comply with all required Danish Medicines Agency
and Therapeutic Goods Administration regulations and testing requirements.
With a growing range of products containing differing ratios of active
ingredients, Little Green Pharma supplies medical-grade cannabis products to
Australian, European and overseas markets.

The Company has a strong focus on patient access in the emerging global
medicinal cannabis market and is actively engaged in promoting education and
outreach programs, as well as participating in clinical investigations and
research projects to develop innovative new delivery systems.

For more information about Little Green Pharma go to:
www.littlegreenpharma.com (http://www.littlegreenpharma.com)

For more information about Reset Mind Sciences go to:
https://www.resetmind.com.au/ (https://www.resetmind.com.au/)

 

 

This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  UPDGPUBWPUPWGUA