A Randomized, Double-Blind, Placebo Controlled, Cross-Over Study to Evaluate the Efficacy, Safety and Tolerability of Daily Oral SCI-110 in Treating Adults With Tourette Syndrome.

To evaluate the efficacy, safety and tolerability of the cannabinoid-based medication SCI-110 compared to placebo in subjects with Tourette syndrome.

Start Date01 Feb 2024

Sponsor / Collaborator

SciSparc Ltd.

NCT05239390 / Unknown statusPhase 2IIT

Phase IIA Open-Label, to Evaluate the Safety, Tolerability, and Efficacy Trend of SCI -110 in Patients With AD and Agitation

As of today, there is no FDA-approved treatment for agitation in AD. Hence, it is still considered an unmet need.
Sporadic observation in healthy or diagnosed individuals indicated that cannabis products, in particular, THC have calming and anti-anxiety effects. These observations are supported by basic science data as well as animal experiments.
SCI -110 is a combination of (1) dronabinol, the active ingredient in an FDA-approved synthetic analog of tetrahydrocannabinol, the psychoactive molecule in the cannabis plant, and (2) palmitoylethanolamide.
In the present study, the starting daily dose for all subjects is 2.5 mg dronabinol and 800 mg PEA and will be gradually increased (every 3 days an addition of 2.5 mg dronabinol per day, with no change in the PEA dose) to a maximum of 12.5 mg Dronebinol and 800 mg PEA per day. The study product will be given orally, twice daily, to add-on the medical treatment.
Study Duration per patient is up to 64 days: a. screening (3-21 days); b. treatment phase: (1) titration (15-23 days) of dronabinol from 2.5 to 12.5 mg or up to the maximal subject's tolerated dose (2) Stabilization phase (10 days) until end of treatment on the highest subject's daily tolerated dose. c. follow-up phase (7 days) - until the end-of-study.
During the study, the tolerability of the drug, its safety (vital signs, physical examinations, blood, and urine tests and side effects follow-up) as well as changes in subject's condition (using CMAI, MMSE, SIB-8 questionnaires), appetite and sleep quality (SDI) will be followed.

Start Date29 Dec 2021

Sponsor / Collaborator-

EUCTR2018-000014-38-DE / Not yet recruitingPhase 2

A Randomized, Double-Blind, Placebo Controlled Proof of Concept Study to Evaluate the Safety, Tolerability and Efficacy of Daily Oral THX-110 in Treating Adults with Tourette Syndrome (ENTOURAGE”) - THX-110 in the treatment of Tourette syndrome

Start Date02 Aug 2018

Sponsor / Collaborator-

100 Clinical Results associated with Dronabinol/Palmidrol

100 Translational Medicine associated with Dronabinol/Palmidrol

100 Patents (Medical) associated with Dronabinol/Palmidrol

Literatures (Medical) associated with Dronabinol/Palmidrol

01 Oct 2021·The Journal of neuropsychiatry and clinical neurosciencesQ4 · MEDICINE

A Phase-2 Pilot Study of a Therapeutic Combination of Δ⁹-Tetrahydracannabinol and Palmitoylethanolamide for Adults With Tourette’s Syndrome

Q4 · MEDICINE

Article

Author: Bloch, Michael H. ; Leckman, James F. ; Landeros-Weisenberger, Angeli ; Johnson, Jessica A.

OBJECTIVE:

There are few effective pharmacological treatments for Tourette's syndrome. Many patients with Tourette's syndrome experience impairing tic symptoms despite use of available evidence-based treatments. The investigators conducted a small, uncontrolled trial to examine the safety, tolerability, and dosing of THX-110, a combination of Δ⁹-tetrahydracannabinol (Δ⁹-THC) and palmitoylethanolamide (PEA), in Tourette's syndrome.

METHODS:

A 12-week uncontrolled trial of THX-110 (maximum daily Δ⁹-THC dose, 10 mg, and a constant 800-mg dose of PEA) in 16 adults with Tourette's syndrome was conducted. The primary outcome was improvement on the Yale Global Tic Severity Scale (YGTSS) total tic score. Secondary outcomes included measures of comorbid conditions and the number of participants who elected to continue treatment in the 24-week extension phase.

RESULTS:

Tic symptoms significantly improved over time with THX-110 treatment. Improvement in tic symptoms was statistically significant within 1 week of starting treatment compared with baseline. THX-110 treatment led to an average improvement in tic symptoms of more than 20%, or a 7-point decrease in the YGTSS score. Twelve of the 16 participants elected to continue to the extension phase, and only two participants dropped out early. Side effects were common but were generally managed by decreasing Δ⁹-THC dosing, slowing the dosing titration, and shifting dosing to nighttime.

CONCLUSIONS:

Although the initial data from this trial in adults with refractory Tourette's syndrome are promising, future randomized double-blind placebo-controlled trials are necessary to demonstrate efficacy of THX-110 treatment. The challenges raised by the difficulty in blinding trials due to the psychoactive properties of many cannabis-derived compounds need to be further appreciated in these trial designs.

News (Medical) associated with Dronabinol/Palmidrol

31 May 2024

·www.globenewswire.com

SciSparc Secures Strategic Advantage with Grant of European Patent

TEL AVIV, Israel, May 31, 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 today that the European Patent Office granted the Company’s patent application titled “Compositions and Methods of Potentiating Antimicrobials”. This is in addition to the patent titled “Compositions and Methods of Potentiating Antimicrobials” previously granted by the United States Patent and Trademark Office. This patent grant bolsters the Company's intellectual property portfolio, extending the protection of its global patent holdings. This grant not only reinforces SciSparc’s position in a key market, but also enhances its competitive edge in the global pharmaceutical landscape. The patent describes the pharmaceutical compositions and methods for potentiating various antimicrobials and minimizing their side-effects. In particular, the invention relates to pharmaceutical compositions comprising antibiotics and cannabinoids, and optionally N-acylethanolamines, and use in treating and/or preventing microbe biofilm formation and microbe-induced pathologies. This innovation is important in the context of antimicrobial and antibiotic resistance, a situation that has led the World Health Organization to classify such antimicrobial resistance as a serious threat. SciSparc has been expanding its intellectual property portfolio, with significant patents recently granted in Canada and Europe, since the beginning of the year. This aggressive expansion emphasizes SciSparc's commitment to securing its innovative technologies globally and highlights the Company’s dynamic approach to research and development. This addition marks another milestone in SciSparc's ongoing efforts to safeguard its core technologies. The Company's intellectual property portfolio now includes patents across several major global territories, including the United States, Europe, Japan, Australia, and Israel, comprising nine patent families and two trademarks. 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 seeds oil-based products on the Amazon.com 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 uses forward-looking statements when it discusses SciSparc’s competitive edge in the market and the Company’s ongoing efforts to safeguard its core technologies. 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, as amended, 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: +972-3-6167055

11 Apr 2024

·www.globenewswire.com

SciSparc to Acquire AutoMax

TEL AVIV, Israel, April 11, 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 today that it signed a merger agreement (the “Agreement”) with AutoMax Motors Ltd. (“AutoMax”), a leading vehicle importer company in Israel. According to the Agreement, the Company will acquire 100% of AutoMax and establish a new wholly-owned Israeli subsidiary, which would in turn merge with and into AutoMax (the “Acquisition”). Following the Acquisition, it is contemplated that SciSparc shareholders will hold together approximately 50.01% of the share capital of the post-closing combined company (the “Combined Company”). The Acquisition follows the Company’s announcement in June 2022, in which the Company’s board of directors resolved to review potential strategic transactions to maximize shareholder value. The Company's ongoing business operations, including its late-stage pharmaceutical segment, will continue to operate. As a result of the Acquisition, all outstanding shares of AutoMax will be converted into the right to receive ordinary shares of SciSparc. Following the closing, it is contemplated that AutoMax’s equity holders will hold together approximately 49.99%, subject to adjustments, of the Combined Company’s share capital. At the closing of the Acquisition, SciSparc has committed to hold at least $4.25 million in net cash. The Acquisition is subject to various approvals, including compliance with any regulatory requirements, including certain Israeli court approvals and SciSparc and AutoMax shareholder approvals. Mr. Amitai Weiss, the chairman of SciSparc, is also the chairman of AutoMax. 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 seeds oil-based products on Amazon Marketplace. About AutoMax Motors Ltd. AutoMax is involved in parallel importation and marketing of various private vehicle products in Israel through Global AutoMax. This includes a diverse range of vehicles such as small family cars, crossover vehicles, executive cars, SUVs, premium vehicles, work vehicles, and vehicles adapted for the disabled. Additionally, AutoMax directly imports and markets buses manufactured by Temsa in Israel through its subsidiary, Delhom AutoMax Ltd. Furthermore, AutoMax engages in the buying and selling of used vehicles (trade-in) through AutoMax Trade-in Ltd. Important Information About the Acquisition for Investors and Shareholders This communication may be deemed to be solicitation material in respect of the proposed transaction between SciSparc and AutoMax. In connection with the proposed transaction between SciSparc and AutoMax, SciSparc will file a registration statement on Form F-4 and a proxy statement with the United States Securities and Exchange Commission (“SEC”). This communication is not a substitute for the registration statement or proxy statement or any other documents that SciSparc may file with the SEC or send to SciSparc shareholders in connection with the proposed transaction. Before making any voting decision, investors and securityholders are urged to read the registration statement and proxy statement and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about the proposed transaction and related matters. Investors and securityholders may obtain free copies of the registration statement, proxy statement and all other documents filed or that will be filed with the SEC regarding the proposed transaction at the website maintained by the SEC at www.sec.gov. Once filed, the registration statement and the proxy statement will be available free of charge on SciSparc’s website at scisparc.com or by contacting SciSparc’s Investor Relations by email at IR@scisparc.com or by phone at +972-3-6167055. Participants in the Solicitation. SciSparc, AutoMax and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the holders of SciSparc’s ordinary shares in connection with the proposed transaction. Information about SciSparc’s directors and executive officers is set forth in SciSparc’s Annual Report on Form 20-F for the fiscal year ended December 31, 2023, which was filed with the SEC on April 1, 2024, and in subsequent filings made by SciSparc with the SEC. Other information regarding the interests of such individuals, as well as information regarding AutoMax’s directors and executive officers and other persons who may be deemed participants in the proposed transaction, will be set forth in the proxy statement, which will be filed with the SEC. You may obtain free copies of these documents as described in the preceding paragraph. This communication shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. 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 risk related to SciSparc’s and AutoMax’s ability to complete the merger on the proposed terms and schedule, including risks and uncertainties related to the satisfaction of the closing conditions related to the Agreement and risks and uncertainties related to the failure to timely, or at all, obtain shareholder approval for the transaction; the execution of definitive agreements; the uncertain and time-consuming court approval process; risks related to the satisfaction of the closing conditions related to the financing; risks related to the combined company’s ability to correctly manage its operating expenses; risks related to the market price of the Company’s ordinary shares relative to the exchange ratio; unexpected costs, charges or expenses resulting from the transaction and potential adverse reactions or changes to business relationships resulting from the announcement or completion of the proposed Merger; risks related to the combined company’s commercialization, marketing and manufacturing capabilities and strategy; risks related to the combined company’s ability to protect its intellectual property position; and the requirement for additional capital to continue to advance the combined company’s operations, which may not be available on favorable terms or available at all. In addition, there can be no assurance that the Company will be able to complete the transactions contemplated by the Merger or related transactions. Because such statements deal with future events and are based on the Company’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of the Company 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 SEC. 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. Contact Information Michal Efraty IR Manager IR@scisparc.comTel: +972-3-6167055

Acquisition

27 Mar 2024

·www.globenewswire.com

SciSparc- Clearmind Collaboration Evolves with New International Patent Application for Preventing and Treating Depression

TEL AVIV, Israel, March 27, 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 today that as part of its ongoing collaboration with Clearmind Medicine Inc. (“Clearmind”) (Nasdaq: CMND) (CSE: CMND) (FSE: CWY), a biotechnology company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated mental health problems, Clearmind has submitted a patent application under the international Patent Cooperation Treaty. The patent application refers to the novel proprietary composition of Clearmind’s MEAI compound (5-methoxy-2-aminoindane) with palmitoylethanolamide (“PEA”), the active ingredient of SciSparc’s proprietary CannAmide™, for preventing and/or treating depression. This application was previously filed as a provisional patent application with the United States Patent and Trademark Office (“USPTO”). According to the ResearchAndMarkets.com, the global depression and anxiety disorders treatment market size was estimated to be USD 21.56 billion in 2023 and is expected to reach at USD 41.83 billion by 2034 with a CAGR of 6.21% during the forecast period 2024-2034. Overall, as part of this collaboration, nine other patent applications have been filed by Clearmind with the USPTO for various compositions, including the composition of SciSparc’s CannAmide™with Clearmind’s MEAI compound for the treatment of alcohol use disorder, cocaine addiction and obesity and its related metabolic disorders. 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 seeds oil-based products on the Amazon.com 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 growth and expected size of the global depression and anxiety disorders treatment market. 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 May 1, 2023, 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

Patent Expiration

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Indication	Highest Phase	Country/Location	Organization	Date
Agitation	Phase 2	IL	-	29 Dec 2021
Alzheimer Disease	Phase 2	IL	-	29 Dec 2021
Alzheimer Disease	Phase 2	IL	SciSparc Ltd.	29 Dec 2021
Dermatitis, Atopic	Phase 2	IL	-	29 Dec 2021
Tourette Syndrome	Phase 2	DE	SciSparc Ltd.	01 Aug 2018
Sleep Apnea, Obstructive	Phase 2	IL	SciSparc Ltd.	04 Jun 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05239390 (GlobeNewswire) Manual	Phase 2	Alzheimer Disease	20	Dronabinol+SCI-110	urlczuaqjc(oqrmtdvsfs) = The primary endpoint was met - SCI-110 administration was found to be safe at all tested doses bqexcrygla (ujwqpovqzu )	Positive	07 Nov 2022
NCT03066193 (Pubmed \| J Neuropsychiatry Clin Neurosci) Manual	Phase 2	Tourette Syndrome	16	THX-110	lbituyubmd(tgnwusgosm) = 7-point decrease ohjuhenmev (nsnzjlimsl )	Positive	01 Jan 2021

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