Vancouver, British Columbia--(Newsfile Corp. - June 14, 2022) - Lobe Sciences Ltd. (CSE: LOBE) (OTCQB: LOBED) ("Lobe" or the "Company"), a Canadian Biopharmaceutical Company committed to discovering and developing psychedelic inspired medicines for the improvement of neurologic, brain and mental health disorders is reporting its roadmap for the remainder of 2022 and into 2023.
Philip Young CEO and Director stated, "I am happy to report that we have made significant progress since our last update in Q3 last year. The next 12 months will see the culmination of investments we've made in the development of therapeutics to treat neurological diseases such as Post Traumatic Stress Disorder (PTSD) and mild Traumatic Brain Injury (mTBI). Preclinical models have shown statistically significant results in the treatment of PTSD and mTBI caused by induced trauma. The combinations of psilocybin with n-acetyl cysteine (NAC) delivered superior results compared to either drug alone. Our patent pending combination therapy may allow for the use of sub-psychedelic dosing while retaining efficacy on these and other disorders."
Lobe is preparing a pre-IND meeting request with the US Food and Drug Administration (FDA) to confirm its regulatory strategy and Phase I clinical protocols. We expect to have this meeting in the 3rd quarter of 2022. Following FDA's input, an IND will be filed and Phase I clinical trials in healthy subjects will be initiated immediately thereafter. Lobe will investigate the safety and tolerability of an oral drug candidate, L-130 (a molecular modification of naturally occurring psilocin) and measure absolute pharmacokinetics of this new chemical entity (NCE) given alone and in conjunction with NAC. Following the successful completion of the first-in-man safety trials, a Phase Ib/IIa study will be implemented in healthy volunteers and patients.
We have secured an exclusive source of L-130 and a series of related compounds for use in clinical trials this year and for subsequent trials in the future. Affirming our access to current good manufacturing practice ("cGMP") pharmaceutical grade active pharmaceutical ingredients (API) will enable us to efficiently conduct clinical trials and plan for further work using differentiated compounds.
Our joint venture with Virtual Psychedelics Inc., which is developing the Krysalis system, has completed the development of an early-stage prototype of the Krysalis Pod System. This is a major step forward as the team works to develop the industry leading platform for use with psychedelic and virtual therapy and counseling content in physician offices and clinics as well as integrating into the newly expanding Metaverse.
I look forward to keeping our shareholders informed as the year unfolds.
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.