CB agonists(Cannabinoid receptor agonists), CB1 inverse agonists(Cannabinoid CB1 receptor inverse agonists), CB2 inverse agonists(Cannabinoid CB2 receptor inverse agonists)

+ [1]

Therapeutic Areas

Nervous System DiseasesOther Diseases

Active Indication

Autism Spectrum DisorderStatus Epilepticus

Inactive Indication

Diabetic peripheral neuropathic pain

Originator Organization

SciSparc Ltd.

Active Organization

SciSparc Ltd.

Inactive Organization

Pure Green Pharmaceuticals, Inc.

Drug Highest PhasePhase 1

First Approval Date-

Regulation-

Structure

Molecular FormulaC18H37NO2

InChIKeyHXYVTAGFYLMHSO-UHFFFAOYSA-N

CAS Registry544-31-0

View All Structures (2)

Clinical Trials associated with Cannabidiol/Palmitoylethanolamide

NCT05182697 / Not yet recruitingNot Applicable

A Randomized, Double-Blind, Sparing-effect Placebo Controlled, With Cross-over Study to Evaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD)

To evaluate the safety and efficacy of SCI-210 in the treatment of Autism Spectrum Disorders (ASD)

Start Date01 Sep 2023

Sponsor / Collaborator

SciSparc Ltd.

NCT05766969 / Unknown statusPhase 1/2

A Randomized, Double-Blind, Placebo-Controlled Trial Using Cannabidiol and Palmitoylethanolamide for the Treatment of Painful Diabetic Peripheral Neuropathy of the Feet

The purpose of the study is to evaluate whether the DIA/NPR-6 is a better pain reliever in patients with diabetic neuropathic pain of the feet compared to placebo.

Start Date05 Jun 2023

Sponsor / Collaborator

Pure Green Pharmaceuticals, Inc.

NCT02645461 / CompletedNot ApplicableIIT

Acetylcholine Receptors From Human Muscles as Pharmacological Target for ALS

Amyotrophic lateral sclerosis (ALS) is a fatal disease leading to motor neuron degeneration and progressive paralysis. Other studies have revealed defects in skeletal muscle even in absence of motor neuron anomalies, focusing on acetylcholine receptors (AChRs) and supporting the so-called "dying-back" hypothesis. Outcome of this study will be to understand if the endocannabinoid palmitoylethanolamide (PEA) can reduce the rundown of AChRs currents in ALS muscle, and if it can modify ALS patients' clinical and electrophysiological parameters.

Start Date01 Jan 2014

Sponsor / Collaborator

Sapienza University of Rome

100 Clinical Results associated with Cannabidiol/Palmitoylethanolamide

100 Translational Medicine associated with Cannabidiol/Palmitoylethanolamide

100 Patents (Medical) associated with Cannabidiol/Palmitoylethanolamide

Literatures (Medical) associated with Cannabidiol/Palmitoylethanolamide

01 Sep 2007·Clinical TherapeuticsQ4 · MEDICINE

Oromucosal Δ9-tetrahydrocannabinol/cannabidiol for neuropathic pain associated with multiple sclerosis: An uncontrolled, open-label, 2-year extension trial

Q4 · MEDICINE

Article

Author: Nurmikko, Turo J. ; Rog, David J. ; Young, Carolyn A.

BACKGROUNDCentral neuropathic pain (CNP), pain initiated or caused by a primary lesion or dysfunction of the central nervous system, occurs in ~28% of patients with multiple sclerosis (MS). Delta(9)-Tetrahydrocannabinol/cannabidiol (THC/CBD), an endocannabinoid system modulator, has demonstrated efficacy for up to 4 weeks in randomized controlled trials in the treatment of CNP in patients with MS.OBJECTIVEThe purpose of this extension was to establish long-term tolerability and effectiveness profiles for THC/CBD (Sativex (R), GW Pharmaceuticals plc, Salisbury, United Kingdom) oromucosal spray in CNP associated with MS.METHODSThis uncontrolled, open-label trial was an indefinite-duration extension of a previously reported 5-week randomized study in patients with MS and CNP. In the initial trial, patients were randomized to placebo or THC/CBD. Patients were only required to maintain their existing analgesia in the randomized study. In the open-label trial they could vary their other analgesia as required. All patients (placebo and THC/CBD) who completed the randomized trial commenced the open-label follow-up on THC/CBD (27 mg/mL: 25 mg/mL). Patients titrated their dosage, maintaining their existing analgesia. The primary end point of the trial was the number, frequency, and type of adverse events (AEs) reported by patients. Secondary end points included changes from baseline in 11-point numerical rating scale (NRS-11) neuropathic pain score, hematology and clinical chemistry test results, vital signs, trial drug usage, and intoxication visual analogue scale scores.RESULTSSixty-six patients were enrolled in the randomized trial; 64 (97%) completed the randomized trial and 63 (95%) entered the open-label extension (race, white, 100%; sex, male, 14 [22%]; mean [SD] age, 49 [8.4] years [range, 27-71 years[). The mean (SD) duration of open-label treatment was 463 (378) days (median, 638 days; range, 3-917 days), with 34 (54%) patients completing >1 year of treatment with THC/CBD and 28 (44%) patients completing the open-label trial with a mean (SD) duration of treatment of 839 (42) days (median, 845 days; range, 701-917 days). Mean NRS-11 pain scores in the final week of the randomized trial were 3.8 in the treatment group and 5.0 in the placebo group. In the 28 (44%) patients who completed the 2-year follow up, the mean (SD) NRS-11 pain score in the final week of treatment was 2.9 (2.0) (range, 0-8.0). Fifty-eight (92%) patients experienced > or =1 treatment-related AE. These AEs were rated by the investigator as mild in 47 (75%) patients, moderate in 49 (78%), and severe in 32 (51%). The most commonly reported AEs were dizziness (27%), nausea (18 %), and feeling intoxicated (11%). Two treatment-related serious AEs (ventricular bigeminy and circulatory collapse) were judged to be treatment-related. Both serious AEs occurred in the same patient and resolved completely following a period of discontinuation. Eleven (17%) patients experienced oral discomfort, 4 persistently. Regular oral examinations revealed that 7 (11%) patients developed white buccal mucosal patches and 2 (3%) developed red buccal mucosal patches; all cases were deemed mild and resolved. Seventeen (25%) patients withdrew due to AEs. The mean number of sprays and patients experiencing intoxication remained stable throughout the follow-up trial.CONCLUSIONSTHC/CBD was effective, with no evidence of tolerance, in these select patients with CNP and MS who completed approximately 2 years of treatment (n = 28). Ninety-two percent of patients experienced an AE, the most common of which were dizziness and nausea. The majority of AEs were deemed to be of mild to moderate severity by the investigators.

News (Medical) associated with Cannabidiol/Palmitoylethanolamide

30 Sep 2024

·www.globenewswire.com

SciSparc Secures FDA Green Light to US Launch of its Pivotal Phase IIb Clinical Trial for Breakthrough Tourette Syndrome Treatment

FDA confirms that SciSparc’s study may proceed only a month after application submission TEL AVIV, Israel, Sept. 30, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, announced that the U.S. Food and Drug Administration (“FDA”) has confirmed that its investigational new drug (“IND”) application for its first in class drug candidate SCI-110 study may proceed with its Phase IIb clinical trials in the U.S. in adults patients with Tourette Syndrome (“TS”). This previously announced FDA approval is one of the most important milestones of SciSparc to date. Oz Adler, Chief Executive Officer of SciSparc, commented “As the currently used medications are managing only a small number of disease symptoms with limited efficacy and questionable safety, we believe there is a clear unmet medical need for the management of TS. The desired therapy for TS should allow for a notable effectiveness, addressing as many symptoms as possible. The therapy of choice should also have a favorable safety profile, allowing for a high patient’s drug compliance. In light of the results from our Phase IIa clinical trial conducted at Yale University that showed an average tic reduction of 21% across the entire sample with almost 40% of the patients experiencing greater than 25% in tic reduction, we believe that our innovative drug candidate SCI-110 has the potential to be this desired therapy” The phase IIb clinical trial will be conducted at three global leading centers of excellence: the Yale Child Study Center at the Yale School of Medicine in Connecticut, United States, the Hannover Medical School in Hannover, Germany, and at the Tel Aviv Sourasky Medical Center in Israel. The Company has already secured the Institutional Review Board approvals from all three clinical sites, as well as approval from all related federal administrations. The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between the ages of 18 and 65 years) using a daily oral treatment. The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo. The primary efficacy objective of the trial will be to assess tic severity change using the Yale Global Tic Severity Scale, the most commonly used measure in clinical trials of this kind, as a continuous endpoint at weeks 12 and 26 of the double-blind phase compared to baseline. The primary safety objective of the trial is to assess absolute and relative frequencies of serious adverse events for the entire population and, separately, for the SCI-110 and placebo groups. About SciSparc Ltd. (Nasdaq: SPRC): SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of TS, for the treatment of Alzheimer's disease and agitation; and SCI-210 for the treatment of ASD and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds oil-based products on Amazon Marketplace. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses: its belief regarding an unmet medical need for the management of TS; the parameters for the desired therapy for TS; its belief that its innovative drug candidate SCI-110 has the potential to become the desired therapy for TS; and the format, structure and objective of the clinical trials for the phase IIb clinical trial. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on April 1, 2024, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. Investor Contact: IR@scisparc.com Tel: +972 3-761-7108

Phase 2INDClinical Result

26 Sep 2024

·www.globenewswire.com

SciSparc Signs Non-Binding Letter of Intent to Sell Stake in MitoCareX

The intended selling valuation represents an increase of 47% from the valuation at the time of SciSparc’s initial investment in MitoCareX Bio TEL AVIV, Israel, Sept. 26, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) (the "Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system, announced it has signed a non-binding letter of intent (“LOI”) to sell its entire ownership interest in MitoCareX Bio Ltd. ("MitoCareX"), the Company’s venture with Dr. Alon Silberman that focuses on drug discovery and development of cancer therapeutics by targeting the mitochondrial SLC25 protein family, to a publicly-traded company in the United States (“the Purchaser”). SciSparc currently owns 52.73% of the issued and outstanding share capital of MitoCareX. Pursuant to the terms of the LOI, initially, in exchange for transferring and selling to the Purchaser a number of ordinary shares of MitoCareX that constitute 27% of its ownership in MitoCareX, SciSparc will receive in cash consideration $700,000. Subsequent to this first phase, SciSparc will transfer to the Purchaser the remaining 73% of its ownership stake in MitoCareX in exchange for a certain number of shares based on the valuation of the Purchaser equal to $8,000,000 and a valuation of MitoCareX equal to $5,000,000 (the latter of which includes the $700,000 in cash consideration for SciSparc’s shares described above). The LOI also includes provisions for additional milestones that, upon achievement, could increase the consideration paid by the Purchaser to SciSparc from $5 million to $7 million. The details of the full terms of this transaction are subject to negotiation and execution of definitive agreements. The valuation of MitoCareX, as described in the LOI, constitutes an increase of 47% since the Company’s first investment in MitoCareX ($3.4 million). “SciSparc is focused on unlocking value through our investments and partnerships,” said Oz Adler, CEO of SciSparc. “We believe that this agreement, which sets the foundation for future value growth through milestone achievements, aligns with our long-term strategy to enhance shareholder value." Mr. Amitay Weiss, who serves as the chairman of the board of directors of SciSparc, also serves as the chairman of the board of directors of the Purchaser. In addition, Ms. Liat Sidi, who also serves as a member of the board of directors of SciSparc, also serves as a member of the board of directors of the Purchaser. About SciSparc Ltd. (Nasdaq: SPRC): SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; SCI-160 for the treatment of pain; and SCI-210 for the treatment of ASD and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seed oil-based products on Amazon Marketplace. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses: the proposed terms of the transactions contemplated by the LOI, including expected valuations of parties involved; the full terms of the contemplated transaction which are subject to negotiation and execution of definitive agreements; and that the Company believes that this LOI aligns with its long-term strategy to enhance shareholder value. The Company may not enter into or complete any definitive agreement for the proposed transactions with the Purchaser or, even if it does, such transactions may not unlock or enhance shareholder value. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on April 1, 2024, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. Investor Contact:IR@scisparc.comTel: +972-3-6167055

AcquisitionExecutive Change

23 Sep 2024

·www.globenewswire.com

SciSparc Receives FDA Approval to Initiate Phase IIb Clinical Trial for Tourette Syndrome Treatment

FDA confirms that SciSparc’s study may proceed following the application submission a month ago TEL AVIV, Israel, Sept. 23, 2024 (GLOBE NEWSWIRE) -- SciSparc Ltd. (Nasdaq: SPRC) ("Company" or "SciSparc"), a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders and rare diseases of the central nervous system, today announced that the U.S. Food and Drug Administration (“FDA”) has confirmed that its investigational new drug (“IND”) application for its first in class drug candidate SCI-110 study may proceed with its Phase IIb clinical trials in the U.S. in adults patients with Tourette Syndrome (“TS”). SciSparc has taken a major step forward with its proprietary SCI-110 for the treatment of Tourette Syndrome (“TS”) with its submission of an IND application to the FDA for its phase IIb clinical trial, as previously announced on August 23, 2024. The phase IIb clinical trial will be conducted at three global leading centers of excellence: the Yale Child Study Center at the Yale School of Medicine in Connecticut, United States, the Hannover Medical School in Hannover, Germany, and at the Tel Aviv Sourasky Medical Center in Israel. The Company has already secured the Institutional Review Board approvals from all three clinical sites, as well as approval from all related federal administrations. Oz Adler, Chief Executive Officer of SciSparc, said “We are very excited to reach this milestone with our first-in-class platform SCI-110 which reinforces our ambition to become a leading company to provide safe and effective treatments to patients with central nervous system disorders. The application was swiftly approved by the FDA within a month after its submission, together with the excellent results we received using this platform in the previous Phase IIa clinical trial, reinforces our belief in our ability to offer a novel safe and effective treatment for Tourette’s patients.” The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients (between the ages of 18 and 65 years) using a daily oral treatment. The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo. The primary efficacy objective of the trial will be to assess tic severity change using the Yale Global Tic Severity Scale, the most commonly used measure in clinical trials of this kind, as a continuous endpoint at weeks 12 and 26 of the double-blind phase compared to baseline. The primary safety objective of the trial is to assess absolute and relative frequencies of serious adverse events for the entire population and, separately, for the SCI-110 and placebo groups. About SciSparc Ltd. (Nasdaq: SPRC): SciSparc Ltd. is a specialty clinical-stage pharmaceutical company led by an experienced team of senior executives and scientists. SciSparc’s focus is on creating and enhancing a portfolio of technologies and assets based on cannabinoid pharmaceuticals. With this focus, the Company is currently engaged in the following drug development programs based on THC and/or non-psychoactive CBD: SCI-110 for the treatment of TS, for the treatment of Alzheimer's disease and agitation; and SCI-210 for the treatment of ASD and status epilepticus. The Company also owns a controlling interest in a subsidiary whose business focuses on the sale of hemp seeds oil-based products on Amazon Marketplace. Forward-Looking Statements: This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. For example, SciSparc is using forward-looking statements when it discusses; the Company’s ambition to become a leading company to provide safe and effective treatments to patients with central nervous system disorders; its belief in its ability to offer a novel safe and effective treatment for TS patients; and the format, structure and objective of the clinical trials for the phase IIb clinical trial. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Because such statements deal with future events and are based on SciSparc's current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of SciSparc could differ materially from those described in or implied by the statements in this press release. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties, including those discussed under the heading "Risk Factors" in SciSparc's Annual Report on Form 20-F filed with the SEC on April 1, 2024, and in subsequent filings with the U.S. Securities and Exchange Commission. Except as otherwise required by law, SciSparc disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date they were made, whether as a result of new information, future events or circumstances or otherwise. Investor Contact: IR@scisparc.com Tel: +972 3-761-7108

Phase 2IND

100 Deals associated with Cannabidiol/Palmitoylethanolamide

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Autism Spectrum Disorder	Phase 1	IL	SciSparc Ltd.	01 Oct 2022
Diabetic peripheral neuropathic pain	Preclinical	US	Pure Green Pharmaceuticals, Inc.	05 Jun 2023
Status Epilepticus	Preclinical	IL	SciSparc Ltd.	01 Aug 2022

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