U.S. Patent Office issues patent number 12,102,616
Patent covers the compositions of matter, methods of use and methods of production for Conjugated Psilocin?
Alera Pharma, Inc., (a newly established wholly owned subsidiary of Lobe Sciences), to proceed with fund-raising and clinical development of Conjugated Psilocin? in neurological disorders
VANCOUVER, British Columbia & STUART, Fla., October 02, 2024--(BUSINESS WIRE)--Lobe Sciences, Ltd. ("Lobe Sciences" or the "Company") (CSE: LOBE), (OTCQB: LOBEF) and Alera Pharma ("Alera or Alera Pharma"), biopharmaceutical companies focused on developing products to treat diseases with significant unmet medical needs, today announce the issuance by the United States Patent and Trademark Office (USPTO) of U.S. Patent number 12,102,616 titled "Psilocin Mucate". As previously announced, Lobe Sciences will assign the intellectual property rights associated with this patent to Alera Pharma.
This newly issued patent contains claims covering compositions of matter, methods of use and methods of production for psilocin mucate. Subject to payment of patent maintenance fees in the third, seventh and eleventh years following the grant, the patent will be valid until expiration in July, 2043. The Company has also filed several additional patent applications with the intention of broadening the base of claims. In addition to filings with the USPTO, the Company has filed for international coverage of its intellectual property.
Mr. Rick Goulburn, CEO of Alera Pharma, Inc. stated, "We are excited to receive this foundational and broad patent on Conjugated Psilocin? which recognizes the unique properties of this psilocin analogue invention. Psilocin alone is a very unstable molecule that to date, has not successfully been developed as an oral stable prescription medicine. Companies trying to develop treatments have had to rely on using the prodrug psilocybin which relies on conversion in the gut resulting in poor bioavailability, uptake, and related adverse effects. With Conjugated Psilocin?, we now have a stable, orally available psilocin that is rapidly and fully bioavailable. As a result, we believe that we can create an oral prescription medication that can be precisely dosed and developed for a variety of neurological disorders."
Dr. Fred Sancilio, Chairman and CEO of Lobe Sciences also commented, "We are excited that this patent has issued and validated the unique opportunity to develop an oral and stable psilocin product. We are highly aware of the desperate need patients with Chronic Cluster Headache have for this medication and we are anxious to move this product through the FDA approval process as quickly and efficiently as possible. However, treating Chronic Cluster Headaches is not our final application of this new and exciting drug candidate, and its potential use to treat several other disorders that are currently being studied in clinical trials utilizing psilocybin are clearly on our radar."
About Conjugated Psilocin?
Conjugated Psilocin? is a novel, oral, stable analogue of psilocin, the active metabolite of the prodrug psilocybin. Psilocybin is a psychedelic compound that has been identified as having therapeutic potential in a variety of neurological conditions. Psilocybin is dephosphorylated to the active moiety psilocin with poor bioavailability and pharmacokinetics. Psilocin itself is a very unstable compound that has been difficult to develop as a pharmaceutical medicine. Conjugated Psilocin? is a stable, highly bioavailable pharmaceutical ingredient with the potential to be developed as a prescription medicine in a variety of neurological disorders.
About Lobe Sciences Ltd.
Lobe Sciences, Ltd. is a commercial stage biotechnology company focused on developing transformative therapies for unmet medical needs. Through its subsidiaries, Alera Pharma, Inc. and Altemia, Inc., Lobe Sciences is developing patented drug candidates to treat chronic cluster headache (Alera) and innovative medical foods to address deficiencies commonly seen in sickle cell disease (Altemia). Lobe Sciences provides common services to its subsidiaries including accounting, finance, and general administrative services.
About Alera Pharma, Inc.
Alera Pharma, Inc. is a private subsidiary of Lobe Sciences, Ltd., dedicated to the development and commercialization of innovative pharmaceutical products. With a focus on addressing unmet medical needs, Alera Pharma is committed to improving patient outcomes in a variety of neurological disorders through cutting-edge research and development.
Cautionary Statement Regarding "Forward-Looking" Information
This news release includes certain statements and information that may constitute forward-looking information within the meaning of applicable Canadian securities laws. All statements in this news release, other than statements of historical facts, including statements regarding future estimates, plans, objectives, timing, assumptions or expectations of future performance, including, without limitation: the belief that the Company and Alera will be able to create an oral prescription medication that can be precisely dosed and developed for a variety of neurological disorders; the belief that patients with Chronic Cluster Headache have a need for Conjugated Psilocin?; the anticipated approval by the FDA, and the timing thereof; and the Company’s belief that psilocybin may be able to treat several other disorders, are forward-looking statements and contain forward-looking information. Generally, forward-looking statements and information can be identified by the use of forward-looking terminology such as "intends" or "anticipates", or variations of such words and phrases or statements that certain actions, events or results "may", "could", "should" or "would" or occur.
Forward-looking statements are based on certain material assumptions and analysis made by the Company and the opinions and estimates of management as of the date of this press release, including, among other things, that: any prescription medication that is developed from Conjugated Psilocin? can be precisely dosed and developed for a variety of neurological disorders; that there is a need for need for Conjugated Psilocin?; the Company will obtain FDA approval for Conjugated Psilocin? and will be able to do so on an expedited timeline; and Conjugated Psilocin? may have use in treatment of other disorders. These forward-looking statements are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking statements or forward-looking information. Important risks that may cause actual results to vary, include, without limitation, the risk that: Conjugated Psilocin? cannot be developed into a precisely dosed prescription medication; the need for Conjugated Psilocin? is less significant than the Company and Alera anticipate; the Company will not obtain FDA approval for Conjugated Psilocin? or will not be able to do so on the timeline anticipated; and Conjugated Psilocin? will not have application in treatment of other disorders.
Although management of the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements and forward-looking information. Readers are cautioned that reliance on such information may not be appropriate for other purposes. The Company does not undertake to update any forward-looking statement, forward-looking information or financial out-look that are incorporated by reference herein, except in accordance with applicable securities laws.
