Lobe Sciences Announces the Completion of cGMP Production of Clinical Supplies For Upcoming Clinical Trials
Appointment of Philip J. Young, CEO, as Board Chairman
Vancouver, British Columbia--(Newsfile Corp. - October 13, 2022) - Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a Canadian Biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced that it has completed the synthesis of bulk L-130, a proprietary form of psilocin, and of the clinical supplies to be used in upcoming trials. The L-130 was manufactured in compliance with U.S. cGMPs (Current Good Manufacturing Practices).
Philip J. Young, Chairman and Chief Executive Officer of the Company stated, "This is an important step and validation of our approach to developing novel psilocin analogues to treat severe forms of anxiety, including a pediatric orphan indication. Our manufacturing partner has produced sufficient quantities of L-130 to dose subjects and patients in our first two Phase 1 programs. Ongoing stability and quality programs are in place to allow the use of all of the data generated in these studies to support our Investigational New Drug Application (IND) planned for early next year."
Dr. Fred Sancilio, Chief Executive Officer of Clearway Global, LLC and Head of Product Development stated, "Lobe Sciences is utilizing a team of global experts and has moved to the forefront in the development of therapeutics based on psychedelics. Our team is following a traditional drug development approach, and has solved many problems that have hindered others trying to develop similar therapeutics."
Phase 1 clinical trials have been contracted with two contract research organizations who will conduct pharmacokinetics, single ascending dose and multiple ascending dose trials. The Company will soon announce the commencement of the first of this series of human studies.
Appointment of Philip J. Young as Board Chairman
On October 10, 2022, Philip J. Young was appointed as Executive Chairman of the board of directors of the Company, effective immediately.
About Lobe Sciences Ltd.
Lobe Sciences is a life sciences company focused on psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using psychedelic compounds and the development of innovative devices and delivery mechanisms to improve mental health and wellness.
For further information please contact:
Lobe Sciences Ltd.
Philip J Young, CEO
Tel: (949) 505-5623
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This does not constitute an offer to sell or a solicitation of offers to buy any securities.
This news release contains forward-looking statements relating to the future operations of the Company and other statements that are not historical facts. Forward-looking statements are often identified by terms such as "will", "may", "should", "anticipate", "expects" and similar expressions. All statements other than statements of historical fact included in this news release (including, without limitation, statements regarding the future plans and objectives of the Company, research and development using psychedelic compounds, and the development of innovative devices and delivery mechanisms to improve mental health and wellness) are forward-looking statements that involve risks and uncertainties. There can be no assurance that such statements will prove to be accurate, and actual results and future events could differ materially from those anticipated in such statements. Readers are cautioned that assumptions used in the preparation of the forward-looking statements may prove to be incorrect. Events or circumstances may cause actual results to differ materially from those predicted, as a result of numerous known and unknown risks, uncertainties, and other factors, many of which are beyond the control of the Company, including changes to the regulatory environment; that the Company's drug research and development activities may be unsuccessful; that drugs and medical devices produced by, or on behalf of, the Company, may not work in the manner intended or at all, and may subject the Company to product liability or other liability claims; that the Company may not be able to attain the Company's corporate goals and objectives; and other risk factors detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com. As a result, the Company cannot guarantee that any forward-looking statement will materialize and the reader is cautioned not to place undue reliance on any forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement. The forward-looking statements contained in this news release are made only as of the date of this news release and the Company does not intend to update any of the included forward-looking statements except as expressly required by applicable Canadian securities laws.
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