As early as the 1950s, scientists were researching the possible therapeutic benefits of psychedelics such as LSD and psilocybin mushrooms.
But by the late 1960s, when the counterculture looked to psychedelics to turn on, tune in and drop out, those substances had earned a bad name, and that set back scientific exploration into their possible constructive uses for decades.
More recently, however, scientists affiliated with universities and biotechnology companies have been examining anew the healing potential of psychedelics with an eye to treating everything from mental illnesses to strokes.
One such company is Lobe Sciences Ltd. (CSE: LOBE | OTC QB: LOBEF), which is working on new compounds that could be used at sub-hallucinogenic levels to address severe anxiety in children as well as provide relief for sufferers of chronic cluster headaches — so devastating they're also known as "suicide headaches" — and treat them at home with a prescription.
A clinical-stage drug development biotechnology company focused on transforming psychedelic medicine to benefit neurological health in patients of all ages. Lobe Sciences is looking to take a bite out of a psychedelic drug market that is estimated to reach USD$10.35 billion by 2028.
Lobe's current focus is on two of its proprietary, patent-pending psilocin compounds, known as L-130 and L-131, which are slated for multiple Phase 1 and 2 human trials in 2023.
Dr. Fred Sancilio of Clearway Global, which is conducting clinical trials of L-130, says "there have been studies of much higher doses of psilocybin, which converts to psilocin in the body, that have showed success in treatment. But those hallucinogenic doses require a patient to remain in a sedate environment under a doctor's supervision and can have a prolonged effect on the recipient."
Additionally, he notes that "the conversion of psilocybin to psilocin varies from patient to patient depending on each individual's metabolism and even what they ate on the day they received treatment."
By developing psilocin as a stable single entity, says Sancilio, who's also a Research Professor in the Department of Chemistry and Biotechnology at Florida Atlantic University, "we've bypassed both the enzymatic conversion in the GI tract and we've enhanced the bioavailability. So, psilocin would be the ideal drug to treat the neurological diseases."
"We are the only company that has psilocin as a single entity," says Lobe's Chief Scientific Officer, Maghsoud Dariani. "We believe the medication by itself is going to be effective and we are pursuing a sub-psychedelic dose, which would be much like any other drug: The doctor prescribes the medication and the patient takes it at home because there is no psychedelic trip involved."
Dariani says "the company believes this will not only be successful medically but, also, that the product will be viable commercially."
He also notes that "Lobe Sciences is seeking orphan drug designations for L-130 and L-131." The U.S. National Cancer Institute defines an orphan drug as one that's used to treat or prevent an orphan disease and explains an orphan disease is a rare, serious and often life-threatening disease that affects fewer than 200,000 people in the U.S. (For instance, fewer than 100,000 people suffer from chronic cluster headaches and there is no approved therapeutic approach).
The Orphan Drug Act gives drug companies financial benefits for developing orphan drugs and grants seven-year market exclusivity to drugs that treat rare diseases.
Regulatory Hurdles are Falling
Sancilio points out that "products derived from mushrooms are already legal in a number of U.S. states" and Phil Young, Chairman and CEO of Lobe Sciences says "while psilocin and related substances may be designated a Schedule 1 drug for now — and lumped in that category with heroin and ecstasy — a bill has been introduced in Congress to move them down to Schedule 3 because they're non-addictive and non-toxic, and have medical potential."
"Such a regulatory change would be a huge positive for Lobe's business, as will the indications that L-130 and L-131 are being developed for and which can be prescribed for at-home use like all other prescription drugs," Young says.
"Phase 1 human testing will kick off early this year, with Phase 2 to follow later in 2023," Young says. The company in January announced it has partnered with Dr. Lauren Natbony and Integrative Headache Medicine of New York to study the tolerability and efficacy of L-130 in patients suffering from chronic cluster headaches and is also working with researchers in Australia on further trials.
Sancilio added that " Lobe Sciences has several human clinical trials contracted with a global network of contract research organizations. The company intends to report data on these trials in the coming months."
With Lobe Sciences poised to make big strides in research — and having recently built a partnership with an API manufacturer — CEO Young says "he expects the company to be attractive to investors, especially as share prices have recently been in the single digits."
"For an investor, it's a very straightforward story," he says. "We have good science, we have good indications with unmet medical needs, we have every indication that the drugs are going to work. And now, for us, it's an execution play. We just have to go out and do it, and that's what we're doing."
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This article originally appeared on Benzinga here .
Lobe Sciences is a biopharmaceutical company focused on developing patient-friendly, practical psychedelic medicines. The Company, through collaborations with industry-leading partners, is engaged in drug research and development using sub-hallucinatory doses of our proprietary compounds for multiple Orphan Diseases. Each of our New Chemical Entities, L-130 and L-131, are being developed to address unmet medical needs in patients suffering from Chronic Cluster Headaches and a Confidential pediatric
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. Drug development involves long lead times, is very expensive and involves many variables of uncertainty. Anticipated timelines regarding drug development are based on reasonable assumptions informed by current knowledge and information available to the Company. Every patient treated on future studies can change those assumptions either positively (to indicate a faster timeline to new drug applications and other approvals) or negatively (to indicate a slower timeline to new drug applications and other approvals). This news release may contain certain forward-looking statements regarding anticipated or possible drug development timelines. Such statements are informed by, among other things, regulatory guidelines for developing a drug with safety studies, proof of concept studies, and pivotal studies for new drug application submission and approval, and assumes the success of implementation and results of such studies on timelines indicated as possible by such guidelines, other industry examples, and the Company's development efforts to date. In addition to the risk factors set out above and those detailed in the Company's continuous disclosure filings from time to time, as available under the Company's profile at www.sedar.com, other factors not currently viewed as material could cause actual results to differ materially from those described in the forward-looking statements. Although Lobe has attempted to identify important risks and factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors and risks that cause actions, events or results not to be anticipated, estimated or intended. Accordingly, readers should not place any undue reliance on forward-looking statements.
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