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lobe sciences ltd. (CSE: LOBE) (OTCQB: LOBEF) ("Lobe" or the "Company"), a North American Biopharmaceutical company committed to discovering and developing psychedelic derived medicines for neurologic and brain disease today announced an update for its clinical development plans for its proprietary Psilocin based compound L-130.
Philip J. Young, Chairman and Chief Executive Officer of the Company stated, "Subsequent to our last communication on the cGMP production of L-130, I wanted to update our stakeholders on our progress as we advance into our Phase 1 clinical trials. We have received regulatory clearance to conduct our Phase 1 study which is a combination of safety and pharmacokinetics evaluation of a fixed dose of L-130." Young continued, "It is important to remember that we are approaching the development of a global commercial markets with a disruptive approach to treating anxiety conditions with sequential sub psychedelic dosing of our compounds. Since the majority of patients with anxiety related conditions are cared for by their personal family physician our goal is to create a treatment regimen that is effective and easily a prescribed by patient's personal physician."
L-130 is regulated as a Schedule 1 substance in the United States and most countries around the world. The Company has received regulatory clearance to import L-130. Initial Phase 1 clinical trials will utilize Clearway Global's network of contract research organizations and we believe that our first subject will enter the first trial in December and topline data will be available for review early in the first quarter of 2023. Data will include safety and pharmacokinetic characteristics of L-130 and psychedelic properties, if any. A second Phase 1 trial is scheduled for the first quarter of 2023 and will accurately assess the therapeutic window for the subsequent Phase 2a trial planned to follow.
As previously announced, the Company has partnered with iNGENu CRO, a contract research organization to finalize and conduct the Phase 2a protocol in Australia. We expect to dose our first patient in our Phase 2 trial in Q2/Q3 2023. We will provide updates as we finalize plans for this important program.
Maghsoud Dariani, CSO of Lobe Sciences added, "it is important to remember that in just 12 months Lobe has transformed into a fully integrated virtual drug development company. We now have multiple New Chemical Entities' (NCE's) including L-130 that is entering human trials. L-131 is entering pre-clinical trials as we prepare a pediatric Orphan Drug Application with the potential of receiving a Priority Review Voucher for L-131. All of this positions Lobe Sciences among the leaders in the small group of companies who are in clinical development of psychedelic drugs."
About lobe sciences ltd.
Lobe Sciences is a life sciences company focused on practical 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.
About Clearway Global, LLC.
Clearway Global, LLC is a wholly owned subsidiary of Sancilio, LLC, a drug development and research organization with a worldwide network of clinical, formulations, regulatory and production capabilities focused on cost-effective pharmaceutical product development. Clearway Global's focus is to manage the drug development process in a cost-effective and timely manner.
For further information please contact:
lobe sciences ltd.
Philip J Young, CEO
info@lobesciences.com
Tel: (949) 505-5623
NEITHER THE CSE NOR ITS REGULATION SERVICES PROVIDER HAVE REVIEWED OR ACCEPT RESPONSIBILITY FOR THE ACCURACY OR ADEQUACY OF THIS RELEASE.
This does not constitute an offer to sell or a solicitation of offers to buy any securities.
Forward-Looking Statements
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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