LOBED - Chronic Cluster Headaches No More: The Promise Of Lobe Sciences' At-Home Psychedelic Treatments Without The Trip!
(NewsDirect)
By Richard Dal Monte
As early as the 1950s,scientists were researching the possible therapeutic benefits ofpsychedelics such as LSD and psilocybin mushrooms.
But by the late 1960s,when the counterculture looked to psychedelics to turn on, tune in anddrop out, those substances had earned a bad name, and that set backscientific exploration into their possible constructive uses fordecades.
Morerecently, however, scientists affiliated with universities andbiotechnology companies have been examining anew the healing potentialof psychedelics with an eye to treating everything from mentalillnesses to strokes.
One such company is Lobe Sciences Ltd. (CSE: LOBE | OTC QB: LOBEF), which is workingon new compounds that could be used at sub-hallucinogenic levels toaddress severe anxiety in children as well as provide relief forsufferers of chronic cluster headaches — so devastating they’realso known as “suicide headaches” — and treat them at home witha prescription.
Aclinical-stage drug development biotechnology company focused ontransforming psychedelic medicine to benefit neurological health inpatients of all ages. Lobe Sciences is looking to take a bite out of apsychedelic drug market that is estimatedto reach USD$10.35 billion by2028.
Lobe’scurrent focus is on two of its proprietary, patent-pending psilocincompounds, known as L-130 and L-131, which are slated for multiplePhase 1 and 2 human trials in 2023.
Psilocin is the key for Lobe Sciences
Dr. Fred Sancilio ofClearway Global, which is conducting clinical trials of L-130, says“there have been studies of much higher doses of psilocybin, whichconverts to psilocin in the body, that have showed success intreatment. But those hallucinogenic doses require a patient to remainin a sedate environment under a doctor’s supervision and can have aprolonged effect on the recipient.”
Additionally, he notes that “the conversionof psilocybin to psilocin varies from patient to patient depending oneach individual’s metabolism and even what they ate on the day theyreceived treatment.”
By developing psilocin as a stable single entity, saysSancilio, who’s also a Research Professor in the Department ofChemistry and Biotechnology at Florida Atlantic University, “we’vebypassed both the enzymatic conversion in the GI tract and we’veenhanced the bioavailability. So, psilocin would be the ideal drug totreat the neurological diseases.”
“We are the only company that has psilocin as asingle entity,” says Lobe’s Chief Scientific Officer, MaghsoudDariani. “We believe the medication by itself is going to beeffective and we are pursuing a sub-psychedelic dose, which would bemuch like any other drug: The doctor prescribes the medication and thepatient takes it at home because there is no psychedelic tripinvolved.”
Dariani says “the company believes this will not only besuccessful medically but, also, that the product will be viablecommercially.”
He also notes that “Lobe Sciences is seeking orphan drugdesignations for L-130 and L-131.” The U.S. National CancerInstitute definesan orphan drug as one that’s used to treat or prevent an orphandisease and explains an orphan disease is a rare, serious and oftenlife-threatening disease that affects fewer than 200,000 people in theU.S. (For instance, fewer than 100,000 people suffer from chroniccluster headaches and there is no approved therapeuticapproach).
TheOrphan Drug Act gives drug companies financial benefits for developingorphan drugs and grants seven-year market exclusivity to drugs thattreat rare diseases.
Regulatory Hurdles are Falling
Sancilio points out that “products derivedfrom mushrooms are already legal in a number of U.S. states” andPhil Young, Chairman and CEO of Lobe Sciences says “while psilocinand related substances may be designated a Schedule 1drug for now — and lumped in that category with heroin andecstasy — a bill has been introduced in Congress to move them downto Schedule 3 because they’re non-addictive and non-toxic, and havemedical potential.”
“Such a regulatory change would be a huge positive forLobe’s business, as will the indications that L-130 and L-131 arebeing developed for and which can be prescribed for at-home use likeall other prescription drugs,” Young says.
“Phase 1 human testingwill kick off early this year, with Phase 2 to follow later in2023,” Young says. The company in January announced it has partnered withDr. Lauren Natbony and Integrative Headache Medicine of New Yorkto study the tolerability and efficacy of L-130 in patients sufferingfrom chronic cluster headaches and is also working with researchersin Australia on further trials.
Sancilio added that “ Lobe Sciences has several humanclinical trials contracted with a global network of contract researchorganizations. The company intends to report data on these trials inthe 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 toinvestors, especially as share prices have recently been in the singledigits.”
“Foran investor, it’s a very straightforward story,” he says. “Wehave 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.”
Learn more about Lobe Sciences Ltd. on its website as well as:
This article originally appeared onBenzinga here .
LobeSciences is a biopharmaceutical company focused on developingpatient-friendly, practical psychedelic medicines. The Company,through collaborations with industry-leading partners, is engaged indrug research and development using sub-hallucinatory doses of ourproprietary compounds for multiple Orphan Diseases. Each of our NewChemical Entities, L-130 and L-131, are being developed to addressunmet medical needs in patients suffering from Chronic ClusterHeadaches and a Confidential pediatric
This news releasecontains forward-looking statements relating to the future operationsof 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 thanstatements of historical fact included in this news release(including, without limitation, statements regarding the future plansand objectives of the Company, research and development usingpsychedelic compounds, and the development of innovative devices anddelivery mechanisms to improve mental health and wellness) areforward-looking statements that involve risks and uncertainties. Therecan be no assurance that such statements will prove to be accurate,and actual results and future events could differ materially fromthose anticipated in such statements. Readers are cautioned thatassumptions used in the preparation of the forward-looking statementsmay prove to be incorrect. Events or circumstances may cause actualresults to differ materially from those predicted, as a result ofnumerous known and unknown risks, uncertainties, and other factors,many of which are beyond the control of the Company, including changesto the regulatory environment; that the Company's drug researchand development activities may be unsuccessful; that drugs and medicaldevices produced by, or on behalf of, the Company, may not work in themanner intended or at all, and may subject the Company to productliability or other liability claims; that the Company may not be ableto attain the Company's corporate goals and objectives; and otherrisk factors detailed in the Company's continuous disclosurefilings from time to time, as available under the Company'sprofile at www.sedar.com. As a result, the Company cannot guaranteethat any forward-looking statement will materialize and the reader iscautioned not to place undue reliance on any forward-lookinginformation. Forward-looking statements contained in this news releaseare expressly qualified by this cautionary statement. Theforward-looking statements contained in this news release are madeonly as of the date of this news release and the Company does notintend to update any of the included forward-looking statements exceptas expressly required by applicable Canadian securities laws. Drugdevelopment involves long lead times, is very expensive and involvesmany variables of uncertainty. Anticipated timelines regarding drugdevelopment are based on reasonable assumptions informed by currentknowledge and information available to the Company. Every patienttreated on future studies can change those assumptions eitherpositively (to indicate a faster timeline to new drug applications andother approvals) or negatively (to indicate a slower timeline to newdrug applications and other approvals). This news release may containcertain forward-looking statements regarding anticipated or possibledrug development timelines. Such statements are informed by, amongother things, regulatory guidelines for developing a drug with safetystudies, proof of concept studies, and pivotal studies for new drugapplication submission and approval, and assumes the success ofimplementation and results of such studies on timelines indicated aspossible by such guidelines, other industry examples, and theCompany’s development efforts to date. In addition to the riskfactors set out above and those detailed in the Company'scontinuous disclosure filings from time to time, as available underthe Company's profile at www.sedar.com, other factors notcurrently viewed as material could cause actual results to differmaterially from those described in the forward-looking statements.Although Lobe has attempted to identify important risks and factorsthat could cause actual actions, events or results to differmaterially from those described in forward-looking statements, theremay be other factors and risks that cause actions, events or resultsnot to be anticipated, estimated or intended. Accordingly, readersshould not place any undue reliance on forward-lookingstatements.
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