• November 30, 2020

GH Research Ltd. Announces Completion of Phase 1 Clinical Study with GH001 (5-Methoxy-N,N-Dimethyltryptamine) in Healthy Volunteers and Updates on Further Progress - Odessa American: Business

e-Edition Subscribe

GH Research Ltd. Announces Completion of Phase 1 Clinical Study with GH001 (5-Methoxy-N,N-Dimethyltryptamine) in Healthy Volunteers and Updates on Further Progress

Print
Font Size:
Default font size
Larger font size

Posted: Thursday, November 19, 2020 6:00 am | Updated: 6:30 am, Thu Nov 19, 2020.

DUBLIN, Nov. 19, 2020 /PRNewswire/ -- GH Research Limited ("GH Research" or "the Company") today announced the successful completion of a Phase 1 clinical study with GH001 in healthy volunteers. The Company is currently recruiting for a Phase 1/2 clinical study with GH001 in patients with Treatment-Resistant Depression.

GH Research is a privately-held, clinical-stage biopharmaceutical company, founded in 2018, developing novel therapies for the management of mental diseases. The Company is focused on developing medicines utilizing 5-Methoxy-N,N-Dimethyltryptamine ("5-MeO-DMT"), a psychoactive substance from the tryptamine class.

The Company's lead product, GH001, is an innovative drug product for 5-MeO-DMT administration via a proprietary inhalation approach. GH001 has the potential to offer an ultra-rapid clearance of symptoms with long-term sustained remission after a single administration session. In the completed Phase 1 healthy volunteer study (GH001-HV-101), GH001 was safe and well-tolerated at the investigated dose levels. A dose range and an individualized dosing regimen for use in patients were defined. GH001 is currently being investigated in a Phase 1/2 trial (GH001-MDD-102) in patients with Treatment-Resistant Depression.

"GH Research is executing an accelerated clinical development program with GH001 in patients with Treatment-Resistant Depression. GH001 has the potential to establish a new paradigm in the treatment of a range of mental diseases," said Florian Schönharting, Chairman of the Board of Directors of GH Research.

Spike Loy, Managing Director at BVF Partners L.P. ("BVF"), a San Francisco-based private investment firm, and a Director of the Company, added, "BVF is excited to be involved with GH Research and it is a privilege to help bring this promising and differentiated program to patients."

The Company plans to clinically investigate GH001 in additional indications. GH002, an innovative injectable formulation of 5-MeO-DMT, is expected to enter the clinic in 2021.

About GH001

GH001 is an innovative drug product for 5-Methoxy-N,N-Dimethyltryptamine (5-MeO-DMT) administration via a proprietary inhalation approach. A healthy volunteer study with GH001 (GH001-HV-101) has been completed, establishing the safety of the inhalation approach and the appropriate GH001 dose range for further clinical studies. A Phase 1/2 study with GH001 in patients with Treatment-Resistant Depression is ongoing (GH001-MDD-102).

About GH Research Ltd.

GH Research Ltd. is a privately-held clinical-stage biopharmaceutical company, founded in 2018, developing novel therapies for the management of mental diseases. The Company's focus is on innovative ultra-rapid and long-acting therapies for people living with mental illness. The Company's lead product, GH001, has the potential to offer ultra-rapid and deep remissions in depression. For more information, see www.ghres.com.

About BVF Partners L.P.

BVF Partners L.P. is a San Francisco-based private investment partnership specializing in fundamentally-driven public biotechnology investments. Since its inception in 1993, BVF has strived to build concentrated, long-term investments in small-cap biotechnology companies while performing rigorous diligence and ongoing monitoring of its investments. BVF is committed to working with its portfolio companies as partners in their successes.

GH Research Ltd. Forward Looking Statements

This press release contains forward-looking statements, all of which are qualified in their entirety by this cautionary statement. Any statements contained herein that do not describe historical facts are forward-looking statements that are based on management's expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcomes, timing and performance to differ materially from those expressed or implied by such statements. These factors, risks and uncertainties include, but are not limited to: the costs and uncertainties associated with the Company's research and development efforts; the inherent uncertainties associated with the conduct, timing and results of preclinical and clinical studies of the Company's product candidates; the Company's ability to obtain, maintain, enforce and defend issued patents; and the adequacy of the Company's capital resources and availability of additional funding. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise any of such statements to reflect events or circumstances occurring after this press release. Readers are cautioned not to place undue reliance on the forward-looking statements contained in this press release.

Contacts For investor inquiries, please contact: investors@ghres.com For media inquiries, please contact: info@ghres.com For more information, see: www.ghres.com GH Research Limited 28 Baggot Street Lower Dublin 2 D02 NX43 Ireland

View original content to download multimedia: http://www.prnewswire.com/news-releases/gh-research-ltd-announces-completion-of-phase-1-clinical-study-with-gh001-5-methoxy-nn-dimethyltryptamine-in-healthy-volunteers-and-updates-on-further-progress-301176992.html

SOURCE GH Research Ltd

© 2020 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.

Odessa, TX

Current Conditions

Clear
44°
Humidity: 25%
Winds: S at 7mph
Feels Like: 39°

Your Extended Forecast

Tomorrow

weather
High 53°/Low 32°
Mainly clear. Lows overnight in the low 30s.

tuesday

weather
High 66°/Low 32°
Partly cloudy. Highs in the mid 60s and lows in the low 30s.

wednesday

weather
High 52°/Low 26°
Sunny. Highs in the low 50s and lows in the mid 20s.
Online Features

Pet Central

pets

Having a pet is a lot of responsibility, and we’ll help by giving you lots of tips and tricks! More >>

Fitness

Fitness

Our fitness articles will help teach you how to work out with gym- and home-based exercises. More >>

Crosswords

Crosswords

Enjoy the crosswords challenge in our free daily puzzles, from the harder Sunday crossword to the quicker daily. More >>

Sudoku

Sudoku

Every Sudoku has a unique solution that can be reached logically. Enter numbers into the blank spaces so that each row, column and 3x3 box contains the numbers 1 to 9. More >>




  • ALL-ACCESS: Subscribe to our e-edition and premium website at myoaoa.com.
    You can read your daily newspaper without taking a walk to the driveway.
    Look back at yesterday's newspaper, or issues from months ago with our archive feature.
    Call circulation at 432-337-7314 to sign up today.