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SciSparc-Clearmind Medicine Collaboration Leads to Publication of International Patent Application for Innovative MDMA-Based Combination Treatment

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SciSparc (Nasdaq: SPRC) and Clearmind Medicine Inc. have announced the publication of an international patent application for an innovative MDMA-based combination treatment. This collaboration aims to enhance the safety and efficacy of mental health and addiction treatments by combining MDMA with N-Acylethanolamines, including Palmitoylethanolamide (PEA).

The partnership has already resulted in thirteen patent applications filed with the U.S. Patent and Trademark Office and other global jurisdictions. SciSparc's CEO, Oz Adler, emphasized that this approach may address FDA concerns regarding MDMA safety, potentially overcoming regulatory barriers and unlocking MDMA's full potential in clinical settings.

SciSparc (Nasdaq: SPRC) e Clearmind Medicine Inc. hanno annunciato la pubblicazione di una domanda di brevetto internazionale per un innovativo trattamento combinato a base di MDMA. Questa collaborazione mira a migliorare la sicurezza e l'efficacia dei trattamenti per la salute mentale e le dipendenze combinando l'MDMA con gli N-Acilethanolamine, inclusa la Palmitoiletanolamide (PEA).

Il partenariato ha già portato a tredici domande di brevetto presentate all'Ufficio Brevetti e Marchi degli Stati Uniti e ad altre giurisdizioni internazionali. Il CEO di SciSparc, Oz Adler, ha sottolineato che questo approccio potrebbe affrontare le preoccupazioni della FDA riguardo alla sicurezza dell'MDMA, superando potenzialmente le barriere normative e sbloccando il pieno potenziale dell'MDMA negli ambienti clinici.

SciSparc (Nasdaq: SPRC) y Clearmind Medicine Inc. han anunciado la publicación de una solicitud de patente internacional para un tratamiento combinado innovador basado en MDMA. Esta colaboración tiene como objetivo mejorar la seguridad y eficacia de los tratamientos para la salud mental y las adicciones al combinar MDMA con N-Aciletanolaminas, incluido el Palmitoiletanolamida (PEA).

La asociación ya ha dado lugar a trece solicitudes de patente presentadas ante la Oficina de Patentes y Marcas de EE. UU. y otras jurisdicciones globales. El CEO de SciSparc, Oz Adler, enfatizó que este enfoque podría abordar las preocupaciones de la FDA sobre la seguridad del MDMA, superando potencialmente las barreras regulatorias y desbloqueando todo el potencial del MDMA en entornos clínicos.

SciSparc (Nasdaq: SPRC)와 Clearmind Medicine Inc.는 혁신적인 MDMA 기반의 복합 치료법에 대한 국제 특허 출원을 발표했습니다. 이 협력은 MDMA와 팔미토일에탄올아마이드(PEA)를 포함한 N-아실에탄올아민을 결합하여 정신 건강 및 중독 치료의 안전성과 효능을 향상시키는 것을 목표로 합니다.

이 파트너십은 이미 미국 특허청 및 기타 글로벌 관할권에서 13건의 특허 출원을 초래했습니다. SciSparc의 CEO인 Oz Adler는 이 접근 방식이 MDMA 안전성에 관한 FDA의 우려를 해결할 수 있을 것으로 강조하며, 규제 장벽을 극복하고 임상 환경에서 MDMA의 잠재력을 완전히 발휘할 수 있을 것이라고 언급했습니다.

SciSparc (Nasdaq: SPRC) et Clearmind Medicine Inc. ont annoncé la publication d'une demande de brevet internationale pour un traitement combiné innovant à base de MDMA. Cette collaboration vise à améliorer la sécurité et l'efficacité des traitements en santé mentale et pour les dépendances en combinant le MDMA avec des N-Acylethanolamines, y compris la Palmitoylethanolamide (PEA).

Le partenariat a déjà donné lieu à treize demandes de brevet déposées auprès de l'Office américain des brevets et des marques et d'autres juridictions mondiales. Le PDG de SciSparc, Oz Adler, a souligné que cette approche pourrait répondre aux inquiétudes de la FDA concernant la sécurité du MDMA, en surmontant potentiellement les obstacles réglementaires et en libérant tout le potentiel du MDMA dans les environnements cliniques.

SciSparc (Nasdaq: SPRC) und Clearmind Medicine Inc. haben die Veröffentlichung einer internationalen Patentanmeldung für eine innovative MDMA-basierte Kombinationstherapie bekannt gegeben. Diese Zusammenarbeit zielt darauf ab, die Sicherheit und Wirksamkeit von Behandlungen für psychische Gesundheit und Sucht zu verbessern, indem MDMA mit N-Acylethanolaminen, einschließlich Palmitoylethanolamid (PEA), kombiniert wird.

Die Partnerschaft hat bereits zu dreizehn Patentanmeldungen geführt, die beim US-Patent- und Markenamt sowie in anderen globalen Jurisdiktionen eingereicht wurden. Der CEO von SciSparc, Oz Adler, betonte, dass dieser Ansatz die Bedenken der FDA hinsichtlich der Sicherheit von MDMA ansprechen könnte, potenziell regulatorische Hürden überwinden und das volle Potenzial von MDMA in klinischen Umgebungen freisetzen könnte.

Positive
  • Publication of international patent application for innovative MDMA-based combination treatment
  • Thirteen patents related to the collaboration filed in multiple jurisdictions
  • Potential to address FDA safety concerns associated with MDMA
  • Aims to enhance both safety and therapeutic potential of mental health and addiction treatments
Negative
  • None.

The publication of this international patent application marks a significant milestone in the development of novel psychedelic-based therapies. By combining MDMA with N-Acylethanolamines, SciSparc and Clearmind are addressing a critical need for safer and more effective treatments in mental health and addiction. This approach could potentially mitigate safety concerns associated with MDMA, which has been a major hurdle in its therapeutic use.

The collaboration has already yielded thirteen patent filings, indicating a robust intellectual property strategy. This positions the companies well in the competitive psychedelic therapeutics market. However, investors should note that patent applications don't guarantee approval or commercial success. The long regulatory pathway for psychedelic-based treatments and potential challenges in clinical trials remain significant hurdles to overcome.

The combination of MDMA with N-Acylethanolamines like PEA represents an innovative approach in psychedelic therapy. MDMA has shown promise in treating PTSD, while PEA is known for its anti-inflammatory and neuroprotective properties. This combination could potentially enhance therapeutic efficacy while reducing side effects, addressing a critical need in mental health treatment.

However, it's important to note that this is still in the early stages. The efficacy and safety of this combination will need to be thoroughly demonstrated through rigorous clinical trials. The FDA's concerns about MDMA safety are well-founded and overcoming these regulatory hurdles will be important for the success of this approach. If successful, this could represent a significant advancement in treating complex mental health disorders and addictions.

This patent application publication is a positive development for both SciSparc and Clearmind, potentially strengthening their positions in the emerging psychedelic therapeutics market. The collaboration leverages SciSparc's expertise in CNS disorders with Clearmind's focus on psychedelic-derived therapeutics, creating a synergistic partnership.

However, investors should exercise caution. The path from patent application to approved therapy is long and uncertain, especially in the highly regulated psychedelics space. While the companies have made progress with multiple patent filings, the real value will be determined by clinical trial results and regulatory approvals. The market for psychedelic-based therapies is becoming increasingly competitive and success will depend on demonstrating clear advantages over other approaches. Financial considerations, including the costs of clinical trials and potential commercialization, will be critical factors to watch in the coming years.

Pioneering Therapeutic Approach Aims to Enhance Safety and Efficacy
in Mental Health and Addiction Treatments

TEL AVIV, Israel, Sept. 06, 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: CWY0), a biotechnology company focused on discovery and development of novel psychedelic-derived therapeutics to solve major under-treated mental health problems, an international patent application under the Patent Cooperation Treaty has been published for the innovative combination of 3,4-Methylenedioxymethamphetamine (MDMA) with N-Acylethanolamines.

As part of their collaboration, SciSparc and Clearmind are researching innovative combination therapies that combine psychedelic molecules with the N-Acylethanolamines family, including Palmitoylethanolamide (PEA). To date, thirteen patents related to this collaboration have been filed by Clearmind with the U.S. Patent and Trademark Office, as well as in several other global jurisdictions.

“The great importance of the cooperation with Clearmind lies in our unceasing attempts to offer effective and safe treatments and today's announcement is another demonstration of this methodology, as we believe that our combined approach may address some of the U.S. Food & Drug Administration’s concerns associated with MDMA safety,” said Oz Adler, Chief Executive Officer of SciSparc. “By integrating MDMA with N-Acylethanolamines like PEA, we aim to enhance both the safety and therapeutic potential of these treatments. This combination offers a promising path forward in the treatment of mental health disorders and addictions, providing an opportunity to overcome regulatory barriers and unlock the full potential of MDMA in clinical settings.”

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 cannabidiol: SCI-110 for the treatment of Tourette Syndrome, for the treatment of Alzheimer's disease and agitation; and SCI-210 for the treatment of autism 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 the Amazon Marketplace.

About Clearmind Medicine Inc.

Clearmind is a clinical-stage psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements.

The Company’s intellectual portfolio currently consists of nineteen patent families including 29 granted patents. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Shares of Clearmind are listed for trading on Nasdaq under the symbol "CMND" and the Frankfurt Stock Exchange under the symbol “CWY0.”

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, the Company is using forward looking statements when it discusses its belief that the patent publication represents the potential of the collaboration between Clearmind and SciSparc to offer effective and safe treatments, that the collaboration approach of Clearmind and SciSparc could address the U.S. Food & Drug Administration’s concerns associated with MDMA safety, that the Company aims to enhance the safety and therapeutic potential of its treatments, and that this combination offers a promising path forward in the treatment of mental health disorders and addictions, providing an opportunity to overcome regulatory barriers and unlock the full potential of MDMA in clinical settings. 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


FAQ

What is the focus of SciSparc and Clearmind Medicine's patent application?

The patent application focuses on an innovative combination treatment using MDMA with N-Acylethanolamines, including Palmitoylethanolamide (PEA), aimed at enhancing safety and efficacy in mental health and addiction treatments.

How many patents has the SciSparc-Clearmind collaboration filed so far?

The collaboration has filed thirteen patents with the U.S. Patent and Trademark Office and several other global jurisdictions.

What potential benefit does SciSparc (SPRC) see in combining MDMA with N-Acylethanolamines?

SciSparc believes this combination may address FDA concerns associated with MDMA safety, potentially overcoming regulatory barriers and enhancing the therapeutic potential of these treatments in clinical settings.

What is the main goal of the SciSparc (SPRC) and Clearmind Medicine collaboration?

The main goal is to develop innovative combination therapies that combine psychedelic molecules with the N-Acylethanolamines family to offer effective and safe treatments for mental health disorders and addictions.

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