Lobe Sciences Ltd. Announces Regulatory and Clinical Development Plans For 2022 and Early 2023
Vancouver, British Columbia--(Newsfile Corp. - July 7, 2022) - Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBED) ("Lobe" or the "Company"), a Canadian Biotechnology company committed to discovering and developing psychedelic derived medicines today announced it has developed its initial Phase 1 study plan intended to demonstrate the safety and appropriate dosing range for its proprietary new chemical entity; L-130. It is also announcing the acquisition of a second new chemical entity, L-131, which is expected to enter preclinical toxicity trials later this year or early in 2023.
Philip Young, CEO of Lobe Sciences stated, "L-130 and L-131 are unique synthetic analogues of psilocin, the active metabolite of natural psilocybin, a substance extracted from a species of psychedelic mushroom. We have designed a regulatory development strategy to support the registration of these new chemical entities with the U.S. Food and Drug Administration (FDA). Our initial focus for our clinical program is to treat neurologic disorders, such as severe anxiety and we are in the final stages of selecting a contract research organization to support these studies."
We expect to submit a Pre-IND meeting request with the FDA in the third quarter of this year. After receiving the FDA response to our Pre-IND questions, we will file our investigational new drug application (IND) to enable us to move forward with our initial clinical study later this year or early in 2023.
Our initial Phase 1 study will evaluate the safety of L-130 in healthy volunteers in a single ascending dose trial. Following this, a second Phase 1 trial will evaluate longer term use of the drug candidate in a multiple ascending dose study (MAD). Once an appropriate dosing level is determined to have no hallucinatory effect, we will conduct a third and final safety study in patients evaluating both pharmacokinetics and preliminary efficacy at the selected dose. This Phase Ib MAD trial will also seek to confirm the synergistic effects seen in preclinical studies when combinations with N-acetyl cysteine (NAC) were administered with a similar psychedelic compound. Lobe has filed a patent protecting the use of NAC in combination with various psychedelic derived compounds.
Lobe's approach is focused on providing a therapeutic that employs sub-psychedelic dose levels to treat patients at home or in their physician's office and avoiding long stays associated with other treatment modalities. Delivering a non-hallucinatory dose of L-130 over several days will enable patients and their doctors the opportunity to maintain their normal routine while receiving treatment.
L-131 will enter preclinical rodent studies in late 2022 or early 2023 to evaluate its safety and pharmacokinetics. The initial trial will be a standard 28-day preclinical safety study to enable human Phase 1 trials planned later in 2023.
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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Disclaimer for 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 release, including 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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