Psyence Biomed Announces Worldwide Exclusive Licensing Agreement with PsyLabs to Supply Nature-Derived Psilocybin to be Evaluated as a Potential Treatment for Alcohol Use Disorder (AUD) and Other Substance Use Disorders (SUDs)
Psyence Biomedical (Nasdaq: PBM) has entered into a worldwide, exclusive royalty-bearing IP licensing agreement with PsyLabs to supply pharmaceutical-grade, EU GMP nature-derived psilocybin for potential treatment of Alcohol Use Disorder (AUD) and other Substance Use Disorders (SUDs). Psyence Biomed plans to focus on AUD as its second development indication, following its first indication of Adjustment Disorder in advanced cancer patients. The licensed product requires further development by PsyLabs throughout 2024 and into 2025.
In 2021, 44.4 million adults in the U.S. had substance or alcohol use disorders, highlighting the significant need for new treatment options. Previous academic studies have shown promise for psilocybin combined with psychotherapy in treating AUD and SUDs.
Psyence Biomedical (Nasdaq: PBM) ha stipulato un accordo di licenza IP esclusivo e remunerato a livello mondiale con PsyLabs per fornire psilocibina derivata dalla natura, di grado farmaceutico e conforme alle norme GMP dell'UE per il potenziale trattamento del Disturbo da Uso di Alcol (AUD) e altri Disturbi da Uso di Sostanze (SUD). Psyence Biomed intende concentrarsi sull'AUD come sua seconda indicazione di sviluppo, dopo la sua prima indicazione di Disturbo di Adattamento in pazienti oncologici avanzati. Il prodotto concesso in licenza richiede ulteriori sviluppi da parte di PsyLabs nel corso del 2024 e fino al 2025.
Nel 2021, 44,4 milioni di adulti negli Stati Uniti avevano disturbi da uso di sostanze o alcol, evidenziando così il notevole bisogno di nuove opzioni terapeutiche. Studi accademici precedenti hanno dimostrato risultati promettenti per l'uso della psilocibina combinata con la psicoterapia nel trattamento dell'AUD e dei SUD.
Psyence Biomedical (Nasdaq: PBM) ha firmado un acuerdo de licencia de propiedad intelectual exclusivo y oneroso a nivel mundial con PsyLabs para suministrar psilocibina derivada de la naturaleza, de grado farmacéutico y conforme a GMP de la UE para el tratamiento potencial del Trastorno por Consumo de Alcohol (AUD) y otros Trastornos por Uso de Sustancias (SUD). Psyence Biomed planea centrarse en el AUD como su segunda indicación de desarrollo, tras su primera indicación de Trastorno de Adaptación en pacientes con cáncer avanzado. El producto licenciado requiere un desarrollo adicional por parte de PsyLabs a lo largo de 2024 y hasta 2025.
En 2021, 44,4 millones de adultos en EE. UU. tenían trastornos por consumo de sustancias o alcohol, lo que destaca la gran necesidad de nuevas opciones de tratamiento. Estudios académicos anteriores han mostrado resultados prometedores para la psilocibina combinada con psicoterapia en el tratamiento del AUD y los SUD.
Psyence Biomedical (Nasdaq: PBM)는 전세계 독점 로열티 지급 IP 라이센스 계약을 PsyLabs와 체결하여 유럽연합 GMP 기준을 충족하는 제약용 천연 유래의 실로시빈을 공급하여 알코올 사용 장애(AUD) 및 기타 물질 사용 장애(SUD)에 대한 잠재적인 치료를 목표로 하고 있습니다. Psyence Biomed는 첫 번째 개발 지표인 암 말기 환자의 적응 장애에 이어 AUD에 중점을 두고 개발할 계획입니다. 라이센스가 부여된 제품은 2024년과 2025년에 걸쳐 PsyLabs에 의한 추가 개발이 필요합니다.
2021년에는 미국에서 4,440만 명의 성인이 물질 또는 알코올 사용 장애를 앓고 있었으며, 이는 새로운 치료 옵션에 대한 상당한 필요성을 강조합니다. 이전의 학문적 연구들은 AUD와 SUD 치료에 있어 심리 치료와 결합된 실로시빈의 유망한 결과를 보여주었습니다.
Psyence Biomedical (Nasdaq: PBM) a signé un accord de licence IP exclusif et rémunéré à l'échelle mondiale avec PsyLabs pour fournir de la psilocybine d'origine naturelle, de qualité pharmaceutique et conforme aux normes GMP de l'UE pour un traitement potentiel du trouble de l'utilisation de l'alcool (AUD) et d'autres troubles liés à la consommation de substances (SUD). Psyence Biomed prévoit de se concentrer sur l'AUD comme sa deuxième indication de développement, après sa première indication de trouble d'adaptation chez les patients atteints de cancer avancé. Le produit sous licence nécessite un développement supplémentaire par PsyLabs tout au long de 2024 et jusqu'en 2025.
En 2021, 44,4 millions d'adultes aux États-Unis avaient des troubles liés à la consommation de substances ou d'alcool, ce qui souligne le besoin considérable de nouvelles options de traitement. Des études académiques antérieures ont montré des résultats prometteurs pour la psilocybine combinée avec la psychothérapie dans le traitement de l'AUD et des SUD.
Psyence Biomedical (Nasdaq: PBM) hat einen weltweiten, exklusiven, lizenzpflichtigen IP-Lizenzvertrag mit PsyLabs abgeschlossen, um pharmazeutische, EU-GMP-konforme, aus der Natur gewonnene Psilocybin für die potenzielle Behandlung von Alkoholkonsumstörungen (AUD) und anderen Substanzkonsumstörungen (SUD) bereitzustellen. Psyence Biomed plant, sich auf AUD als zweite Entwicklungsindikations zu konzentrieren, nach seiner ersten Indikation für Anpassungsstörungen bei fortgeschrittenen Krebspatienten. Das lizensierte Produkt erfordert eine weitere Entwicklung durch PsyLabs im Jahr 2024 und bis 2025.
Im Jahr 2021 hatten 44,4 Millionen Erwachsene in den USA Störungen des Substanz- oder Alkoholkonsums, was den erheblichen Bedarf an neuen Behandlungsoptionen verdeutlicht. Frühere akademische Studien haben vielversprechende Ergebnisse für Psilocybin in Kombination mit Psychotherapie bei der Behandlung von AUD und SUD gezeigt.
- Exclusive worldwide licensing agreement for pharmaceutical-grade psilocybin supply
- Expansion into AUD and SUDs treatment, addressing a large market of 44.4 million affected adults in the U.S.
- Potential for a novel treatment paradigm in AUD and SUDs with significant unmet needs
- Licensed product requires further development work throughout 2024 and into 2025
- Clinical trials for AUD treatment have not yet commenced
This licensing agreement marks a significant step for Psyence Biomed in expanding its drug development pipeline. The focus on Alcohol Use Disorder (AUD) as their second indication is strategic, given the large patient population and efficacy of current treatments. The partnership with PsyLabs for nature-derived psilocybin supply could potentially differentiate Psyence Biomed's product in the market.
However, investors should note that the development work by PsyLabs will extend into 2025, indicating a long timeline before potential commercialization. The exclusive worldwide rights are a strong positive, but success will ultimately depend on clinical trial outcomes and regulatory approvals. The company's dual focus on AUD and Adjustment Disorder in cancer patients demonstrates a diversified approach to psychedelic therapeutics.
The potential use of psilocybin for AUD and other SUDs is an exciting development in the field of addiction treatment. Previous academic studies have shown promising results, but it's important to remember that these were small-scale trials. Psyence Biomed's planned clinical trials will be essential in validating these findings on a larger scale.
The combination of psilocybin with psychotherapy represents a novel treatment paradigm that could address both the neurobiological and psychological aspects of addiction. If successful, this approach could offer hope to the
The regulatory pathway for psychedelic-based treatments is complex and evolving. Psyence Biomed's focus on pharmaceutical-grade, EU GMP nature-derived psilocybin is a smart move, as it aligns with stringent regulatory standards. However, the company will face significant challenges in navigating the regulatory landscape for a controlled substance.
The planned Phase IIb trial for Adjustment Disorder in cancer patients could provide valuable data and potentially expedite the regulatory process for the AUD indication. Investors should closely monitor the company's interactions with regulatory bodies, as these will be critical in determining the timeline and likelihood of market approval. The exclusive worldwide rights secured through this agreement could provide a competitive advantage, but regulatory approvals will ultimately dictate market access.
Psyence Biomed to focus on AUD, its second development indication
NEW YORK, Sept. 04, 2024 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM, PBMWW) (“Psyence Biomed” or the “Company”) today announced that the Company has entered into a worldwide, exclusive royalty-bearing IP licensing agreement with PsyLabs, a private company focused on the production of psychedelic active pharmaceutical ingredients and extracts. Pursuant to this licensing agreement, PsyLabs will supply Psyence Biomed with pharmaceutical-grade, EU GMP nature-derived (non-synthetic) psilocybin to be evaluated in future clinical trials as a potential treatment for AUD and other SUDs, and for commercialization of the licensed product. Psyence Biomed plans to lead with a clinical trial in AUD, Psyence Biomed’s second development indication. The licensed product will require further development work by PsyLabs, which will be conducted during the remainder of 2024 and into 2025.
Development of Psyence Biomed’s first indication is planned to commence with a Phase IIb trial to evaluate nature-derived psilocybin in Adjustment Disorder in patients who have had an advanced cancer diagnosis in the Palliative Care context.
In 2021 in the U.S., 44.4 million people aged 18 or older had a substance or alcohol use disorder, including 21.8 million who had an alcohol use disorder (AUD), 15.6 million who had a drug use disorder (DUD), and 7.0 million people who had both an AUD and a DUD1. Existing treatments include behavioral therapies, mutual-support groups, and/or medications.
“Alcohol and substance use disorders represent significant burdens to society, and prior academic studies2,3,4 have shown that psilocybin, when combined with psychotherapy, can be a safe and effective treatment option for the millions of people suffering from AUD and other SUDs for whom current treatment options are of limited benefit,” stated Neil Maresky, MD, Chief Executive Officer of Psyence Biomed. “As we pursue our next indications, this new agreement with PsyLabs demonstrates our commitment to advance the highest quality psilocybin candidate into clinical development.”
“At PsyLabs, we have worked tirelessly to develop extraction and production capabilities that we believe will result in the purest pharmaceutical grade nature-derived psilocybin available to psychedelic drug developers worldwide,” stated Tony Budden, Chief Executive Officer of PsyLabs. “We are very pleased to enter into this exclusive agreement with Psyence Biomed and look forward to playing a key role in the potential introduction of a novel treatment paradigm for AUD and other SUDs, significant patient populations with urgent unmet needs.”
About PsyLabs
PsyLabs is a psychedelic Active Pharmaceutical Ingredient (API) development company that is federally licensed to cultivate and export psilocybin mushrooms and other psychedelic compounds, including psilocin, mescaline, ibogaine and dimethyltryptamine (DMT) to the legal medical and research markets. PsyLabs has been able to successfully demonstrate, at laboratory scale, purification of natural psilocybin to levels not seen before in the industry using its proprietary extraction and purification technologies. It is in the process of scaling to full scale commercial production of Psilocybin and into a fully formulated product, with the accompanying regulatory approvals. This work is being done in collaboration with the largest U.K. owned contract manufacturing organization.
Learn more at www.psylabs.life
Contact Information
General Information: tony@psylabs.life
About Psyence Biomed
Psyence Biomedical Ltd. (Nasdaq: PBM) is the world’s first life science biotechnology company focused on the development of botanical (nature derived, or non-synthetic) psilocybin-based psychedelic medicine to be listed on Nasdaq. The name “Psyence” combines the words “psychedelics” and “science” to affirm Psyence Biomed’s commitment to an evidence-based approach to innovation as it works to develop safe and effective, nature-derived psychedelic therapeutics to treat a broad range of mental health disorders. The Company is initially focused on mental health disorders in the context of Palliative Care.
Learn more at www.psyencebiomed.com and on LinkedIn.
Contact Information
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact:
Jeremy Feffer
Managing Director
LifeSci Advisors
jfeffer@lifesciadvisors.com
Forward Looking Statements
This communication contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements about future financial and operating results, our plans, objectives, expectations and intentions with respect to future operations, products and services; and other statements identified by words such as "will likely result," "are expected to," "will continue," "is anticipated," "estimated," "believe," "intend," "plan," "projection," "outlook" or words of similar meaning.
Forward-looking statements in this communication include statements regarding the commencement of the clinical trials referred to in this news release and the safety and effectiveness of psilocybin as a possible treatment option for AUD and SUD, as well as Adjustment Disorder. These forward-looking statements are based on a number of assumptions.
There are numerous risks and uncertainties that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, among others: (i) the ability of PsyLabs to execute its obligations under the exclusive agreement; (ii) Psyence Biomed’s ability to successfully carry out future clinical trials relating to AUD and SUD, as well as Adjustment Disorder; (iii) Psyence Biomed’s ability to obtain regulatory approval for its product candidates, and any related restrictions or limitations of any approved products; (iv) Psyence Biomed’s ability to obtain licensing of third-party intellectual property rights for future discovery and development of its product candidates; (v) the ability of Psyence Biomed to maintain the listing of its common shares and warrants on Nasdaq; and (vi) volatility in the price of the securities of Psyence Biomed due to a variety of factors, including changes in the competitive and highly regulated industries in which Psyence Biomed operates, variations in performance across competitors, changes in laws and regulations affecting Psyence Biomed’s business and changes in Psyence Biomed’s capital structure. The foregoing list of factors is not exhaustive. You should carefully consider the foregoing factors and the other risks and uncertainties described in the "Risk Factors" section of the Registration Statement on Form F-1, initially filed by the Company with the SEC on February 9, 2024 and other documents filed by the Company from time to time with the SEC. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Actual results and future events could differ materially from those anticipated in such information. Nothing in this communication should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Except as required by law, the Company does not intend to update these forward-looking statements.
The Company makes no medical, treatment or health benefit claims about the Company’s proposed products. The U.S. Food and Drug Administration, Health Canada or other similar regulatory authorities have not evaluated claims regarding psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceutical products. The efficacy of such products has not been confirmed by approved research. There is no assurance that the use of psilocybin, psilocybin analogues, or other psychedelic compounds or nutraceuticals can diagnose, treat, cure or prevent any disease or condition. Vigorous scientific research and clinical trials are needed. The Company has not conducted clinical trials for the use of its proposed products. Any references to quality, consistency, efficacy, and safety of potential products do not imply that the Company verified such in clinical trials or that the Company will complete such trials. If the Company cannot obtain the approvals or research necessary to commercialize its business, it may have a material adverse effect on the Company’s performance and operations.
1 Department of Health and Human Services (HHS), Substance Abuse and Mental Health Services Administration (SAMHSA), 2022 National Survey on Drug Use and Health (NSDUH), Table 5.1A
2 https://jamanetwork.com/journals/jama/article-abstract/2796962#:~:text=Using%20psilocybin%20(a%20psychedelic,trial%20published%20in%20JAMA%20Psychiatry
3 https://pubmed.ncbi.nlm.nih.gov/36001306/
4 https://www.frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2023.1134454/full
FAQ
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