Lobe Sciences Ltd (CSE:LOBE, OTCQB:LOBED), which is focused on developing psychedelic-derived medicines for neurologic disease, revealed that it has signed an Investigator Initiated Research Agreement with Dr Lauren Natbony, who is the founder and medical director of Integrative Headache Medicine of New York, to study the tolerability and effectiveness of Lobe’s psilocin compound L-130, in patients suffering from cluster headaches (CH).
In a statement, Lobe Sciences CEO Philip Young said: "This is an exciting opportunity to evaluate L-130's effect on the intensity, frequency, and duration of these debilitating headaches.”
He added: “One in every thousand people suffers from this condition, also called 'suicide headaches,' due to the pain, frequency of attacks, and lack of effective treatments. Partnering with Dr Natbony is a great opportunity for Lobe. As a board-certified neurologist and fellowship-trained headache specialist, she has dedicated her career to treating chronic headache and facial pain disorders, including cluster headache.”
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The Vancouver-based biopharmaceutical company expects Dr Natbony to file a physician-initiated Investigational New Drug Application (IND).
“And when cleared by the US Food and Drug Administration (FDA), she can begin dosing cluster headache patients with L-130 to evaluate safety, tolerability, and efficacy,” added Young. “CH is recognized as an Orphan Drug indication, which we intend to pursue."
Meanwhile, Dr Natbony said she is “very excited” to evaluate the impact of Lobe's psilocin compound L-130 in treating these “devastating headaches.”
“Data reported in the literature supports the use of psilocybin in these patients. Since L-130 is the active metabolite of psilocybin, it appears to be an efficient way of delivering non-psychedelic doses of psilocin with potentially better bioavailability and consistency,” noted Dr Natbony. “Using sub-psychedelic dosing may allow physicians a therapeutic solution to a devastating condition where treatment options are limited."
Cluster headaches
A cluster headache is a rare but severe primary headache disorder, impacting 0.1% of the population, characterized by excruciating one-sided pain around the eye. The pain is so intense that it causes restlessness and agitation during an attack with the need to pace or rock in place. Attacks can happen up to eight times a day and last between 15 minutes and three hours.
Accompanying the attacks are one-sided autonomic symptoms, such as eye redness, eye tearing, nasal congestion, runny nose, or a droopy eyelid, said the company. Cluster headache, in its episodic form, occurs in episodes lasting between 7 days and one year with pain-free periods lasting at least three months, it added.
In contrast, Lobe pointed out that a cluster headache is classified as “chronic” once attacks are present for “more than one year,” either without interruption or with short intermissions “lasting less than three months.” A chronic cluster headache is more resistant to current treatments, noted the company.
Lobe said that each of its new chemical entities — L-130 and L-131 — are being developed to address unmet medical needs.
Contact the author Uttara Choudhury at uttara@proactiveinvestors.com
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