Vistagen Receives U.S. Patent for AV-101 to Treat Neuropathic Pain
Vistagen (VTGN) has been granted a U.S. patent for AV-101, its oral non-opioid product candidate for treating neuropathic pain. The patent extends until at least 2034 and is part of Vistagen's global patent portfolio for AV-101's manufacturing methods and therapeutic uses involving the NMDA receptor.
Preclinical studies published in The Journal of Pain showed AV-101's antinociceptive effects similar to gabapentin but with a better side effect profile. Additional research comparing AV-101 to pregabalin demonstrated significant dose response and similar efficacy in chronic neuropathic pain models.
Clinical data from Phase 1 studies published in the Scandinavian Journal of Pain indicated that oral AV-101 was well-tolerated, showing no meaningful difference in adverse events between AV-101 and placebo. The company is now seeking strategic collaborations to advance AV-101's clinical development and commercialization for pain and dyskinesias.
Vistagen (VTGN) ha ottenuto un brevetto negli Stati Uniti per AV-101, il suo candidato terapeutico orale non oppioide per il trattamento del dolore neuropatico. Il brevetto è valido fino almeno al 2034 ed è parte del portafoglio globale di brevetti di Vistagen per i metodi di produzione e le applicazioni terapeutiche di AV-101 che coinvolgono il recettore NMDA.
Studi preclinici pubblicati in The Journal of Pain hanno dimostrato effetti antinocicettivi di AV-101 simili a quelli della gabapentina, ma con un profilo più favorevole di effetti collaterali. Ulteriori ricerche che confrontano AV-101 con il pregabalin hanno mostrato una risposta dose-dipendente significativa e un'efficacia simile nei modelli di dolore neuropatico cronico.
I dati clinici degli studi di Fase 1 pubblicati nel Scandinavian Journal of Pain hanno indicato che l'AV-101 orale era ben tollerato, senza differenze significative negli eventi avversi tra AV-101 e placebo. La società sta ora cercando collaborazioni strategiche per avanzare nello sviluppo clinico e nella commercializzazione di AV-101 per il dolore e le discinesie.
Vistagen (VTGN) ha obtenido una patente en EE.UU. para AV-101, su candidato a producto oral no opioide para el tratamiento del dolor neuropático. La patente se extiende hasta al menos 2034 y forma parte del portafolio global de patentes de Vistagen para los métodos de fabricación y aplicaciones terapéuticas de AV-101 que involucran el receptor NMDA.
Estudios preclínicos publicados en The Journal of Pain demostraron efectos antinociceptivos de AV-101 similares a los de la gabapentina, pero con un perfil de efectos secundarios más favorable. Investigaciones adicionales que comparan AV-101 con pregabalina mostraron una respuesta significativa a la dosis y una eficacia similar en modelos de dolor neuropático crónico.
Los datos clínicos de estudios de Fase 1 publicados en el Scandinavian Journal of Pain indicaron que AV-101 oral fue bien tolerado, sin diferencias significativas en eventos adversos entre AV-101 y placebo. La compañía está buscando ahora colaboraciones estratégicas para avanzar en el desarrollo clínico y la comercialización de AV-101 para el dolor y las discinesias.
비스타젠(VTGN)은 신경병증 통증 치료를 위한 비오피오이드 경구 제품 후보인 AV-101에 대한 미국 특허를 받았습니다. 이 특허는 최소한 2034년까지 유효하며, NMDA 수용체와 관련된 AV-101의 제조 방법과 치료적 용도에 대한 비스타젠의 글로벌 특허 포트폴리오의 일환입니다.
The Journal of Pain에 발표된 전임상 연구에서는 AV-101의 항통증 효과가 가바펜틴과 유사하지만 부작용 프로필이 더 우수하다고 보고되었습니다. AV-101과 프레가발린을 비교하는 추가 연구는 만성 신경병증 통증 모델에서 유의미한 용량 반응과 유사한 효능을 나타냈습니다.
Scandinavian Journal of Pain에 발표된 1상 연구의 임상 데이터는 경구 AV-101이 잘 견딜 수 있고 AV-101과 위약 그룹 사이에 부작용에서 유의미한 차이가 없음을 보여주었습니다. 회사는 이제 통증 및 운동장애를 위한 AV-101의 임상 개발 및 상용화를 진행하기 위해 전략적 협력을 모색하고 있습니다.
Vistagen (VTGN) a obtenu un brevet américain pour AV-101, son candidat produit oral non opioïde pour le traitement de la douleur neuropathique. Le brevet est valable jusqu'à au moins 2034 et fait partie du portefeuille mondial de brevets de Vistagen pour les méthodes de fabrication et les utilisations thérapeutiques d'AV-101 impliquant le récepteur NMDA.
Des études précliniques publiées dans The Journal of Pain ont montré que les effets antinociccatifs d'AV-101 sont similaires à ceux de la gabapentine, mais avec un profil d'effets secondaires supérieur. Des recherches supplémentaires comparant AV-101 au prégabaline ont démontré une réponse posologique significative et une efficacité similaire dans les modèles de douleur neuropathique chronique.
Les données cliniques des études de Phase 1 publiées dans le Scandinavian Journal of Pain ont indiqué que l'AV-101 oral était bien toléré, sans différence significative des événements indésirables entre AV-101 et le placebo. L'entreprise cherche maintenant des collaborations stratégiques pour faire progresser le développement clinique et la commercialisation d'AV-101 pour la douleur et les dyskinésies.
Vistagen (VTGN) hat ein US-Patent für AV-101, seinen oralen nicht-opioiden Produktkandidaten zur Behandlung von neuropathischen Schmerzen, erhalten. Das Patent läuft mindestens bis 2034 und ist Teil des globalen Patentportfolios von Vistagen für die Herstellungsverfahren und therapeutischen Anwendungen von AV-101, die den NMDA-Rezeptor betreffen.
Präklinische Studien, die in The Journal of Pain veröffentlicht wurden, zeigten, dass AV-101 antinociceptive Effekte hat, die denen von Gabapentin ähnlich sind, jedoch ein besseres Nebenwirkungsprofil aufweisen. Zusätzliche Forschungen, die AV-101 mit Pregabalin vergleichen, zeigten eine signifikante Dosis-Wirkungs-Beziehung und eine ähnliche Wirksamkeit in Modellen für chronische neuropathische Schmerzen.
Klinische Daten aus Phase-1-Studien, die im Scandinavian Journal of Pain veröffentlicht wurden, wiesen darauf hin, dass AV-101 oral gut verträglich war und zwischen AV-101 und Placebo keine bedeutenden Unterschiede bei unerwünschten Ereignissen festgestellt wurden. Das Unternehmen sucht nun strategische Kooperationen, um die klinische Entwicklung und die Vermarktung von AV-101 für Schmerzen und Dyskinesien voranzutreiben.
- Patent protection secured until at least 2034
- Preclinical data shows efficacy similar to existing treatments with better side effect profile
- Phase 1 clinical trials demonstrated good tolerability
- Phase 1 study was not designed to achieve statistical significance in pain reduction
- Still requires strategic partnerships for further development
- Significant additional clinical development needed before commercialization
Insights
The USPTO patent grant for AV-101 marks a pivotal development for Vistagen, substantially strengthening its competitive position in the $6.8 billion global neuropathic pain market. The patent protection extending to 2034 is particularly valuable as it covers both manufacturing methods and therapeutic applications targeting the NMDA receptor pathway.
The preclinical data comparing AV-101 to established treatments like gabapentin and pregabalin is especially noteworthy. Current first-line treatments for neuropathic pain, including gabapentinoids and antidepressants, often come with significant side effects such as dizziness, somnolence and weight gain, limiting their therapeutic utility. AV-101's demonstrated efficacy with a potentially superior safety profile addresses a critical unmet need in pain management.
The strategic value of this patent extends beyond mere protection - it creates multiple monetization pathways. The comprehensive IP coverage of both manufacturing methods and therapeutic uses makes AV-101 particularly attractive for potential licensing deals or strategic partnerships. In the current environment where pharmaceutical companies are actively seeking non-opioid pain solutions, this patent portfolio significantly enhances Vistagen's negotiating position for potential collaboration agreements.
The NMDA receptor mechanism of AV-101 is particularly relevant as it suggests potential applications beyond neuropathic pain, including dyskinesias and other neurological disorders. This broad therapeutic potential, combined with the demonstrated safety profile in Phase 1 trials, positions AV-101 as a versatile asset in Vistagen's portfolio.
“This new patent advances our AV-101 portfolio and significantly strengthens our position for potential collaborative development and commercialization of this clinical-stage product candidate,” stated Shawn Singh, President and Chief Executive Officer of Vistagen. “We look forward to identifying potential partnering opportunities for AV-101 as a non-opioid alternative for pain, as well as dyskinesias and other neurological disorders.”
Preclinical data previously published in the peer-reviewed journal, The Journal of Pain,1 demonstrate robust antinociceptive effects of AV-101, similar to gabapentin, but with a better side effect profile in several preclinical models of hyperalgesia and allodynia. Compared to the control drugs tested (gabapentin and MK-801), AV-101 has similar robust anti-nociceptive effects, but contrary to the control drugs tested, non-opioid AV-101 had no discernable negative side effects. The preclinical study was conducted by Tony L. Yaksh, Ph.D., Professor of Anesthesiology and Pharmacology at the University of
Further preclinical research conducted by Dr. Yaksh comparing AV-101 to pregabalin in the Chung ligation model of pain, an accepted gold standard preclinical model for chronic neuropathic pain caused by nerve damage, demonstrated that AV-101 had a significant dose response with similar efficacy in this rat model of a mononeuropathy as compared to pregabalin, which was used as an active comparator. The statistically significant positive preclinical results suggest AV-101’s potential to treat multiple hyperpathic pain states.2
Additionally, clinical data from both the single and multi-dose Phase 1 studies previously published in the peer-reviewed publication, Scandinavian Journal of Pain,3 indicated that oral AV-101 was well-tolerated, with no meaningful difference in adverse events at any dose between AV-101 and placebo. While the AV-101 study was not designed to achieve statistical significance in reducing pain in healthy volunteers, there were consistent reductions for allodynia pain and mechanical and heat hyperalgesia. The study was conducted by Mark S. Wallace, M.D., Professor of Anesthesiology and Pain Management Specialist at the University of
Vistagen plans to seek potential strategic collaborations to further advance the potential clinical development and commercialization of AV-101 for disorders involving the NMDA receptor, particularly pain and dyskinesias.
About AV-101
AV-101 (4-Cl-KYN) is an investigational non-opioid oral prodrug that targets the NMDA receptor, an ionotropic glutamate receptor in the brain. AV-101’s active metabolite, 7-Cl-KYNA, is not an ion channel blocker, unlike classic channel-blocking NMDA receptor antagonists such as ketamine and amantadine, which the Company believes is the reason for the compound’s comparatively improved safety and tolerability profile. In clinical and nonclinical testing completed to date, AV-101 has demonstrated high oral bioavailability, efficient transport across the blood-brain barrier, a postulated preferential conversion to 7-Cl-KYNA in brain areas most affected by Parkinson’s disease, and an excellent pharmacokinetic (PK) profile.
No binding of AV-101 or 7-Cl-KYNA to off-site targets was identified by an extensive receptor screening study. Moreover, in all clinical trials completed to date, AV-101 has been well-tolerated with no serious adverse psychological side effects or other safety concerns that are often observed with classic channel-blocking NMDA receptor antagonists. Clinical studies to date also suggest an improved side effect profile vs. other non-opioid drugs approved to treat conditions associated with pain, such as gabapentin (approved to treat post-herpetic neuralgia and adjunctively to treat partial onset epileptic seizures) and pregabalin (approved to treat neuropathic pain associated with diabetic peripheral neuropathy and post-herpetic neuralgia), both of which produce sedation in some patients.
A range of preclinical and Phase 1 clinical studies suggest AV-101’s therapeutic potential in multiple CNS indications, including levodopa-induced dyskinesia, neuropathic pain, and seizures. The
About Vistagen
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1 Yaksh, T.L., et al. (2017). “Characterization of the Effects of L-4-Chlorokynurenine on Nociception in Rodents.” The Journal of Pain 18:1184-1196. https://doi.org/10.1016/j.jpain.2017.03.014
2 Vistagen, data on file
3Wallace, M. et. al. (2017). “Randomized, double-blind, placebo-controlled, dose-escalation study: Investigation of the safety, pharmacokinetics, and antihyperalgesic activity of L-4-chlorokynurenine in healthy volunteers.” Scandinavian Journal of Pain 17(1): 243-251. https://doi.org/10.1016/j.sjpain.2017.05.004
4 Dr. Mark S. Wallace serves as an advisor to Vistagen
Forward-looking Statements
This press release contains certain forward-looking statements within the meaning of the federal securities laws. These forward-looking statements involve known and unknown risks that are difficult to predict and include all matters that are not historical facts. In some cases, you can identify forward-looking statements by the use of words such as “may,” “could,” “expect,” “project,” “outlook,” “strategy,” “intend,” “plan,” “seek,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “strive,” “goal,” “continue,” “likely,” “will,” “would” and variations of these terms and similar expressions, or the negative of these terms or similar expressions. Such forward-looking statements are necessarily based upon estimates and assumptions that, while considered reasonable by Vistagen and its management, are inherently uncertain. As with all pharmaceutical products, there are substantial risks and uncertainties in the process of development and commercialization and actual results or development may differ materially from those projected or implied in these forward-looking statements. There can be no guarantee that the scope of protection and enforceability provided by any patents issued for any of Vistagen’s product candidates, including AV-101, will be sufficient to deter competition, or that any of Vistagen’s product candidates, including AV-101, will successfully replicate past preclinical studies and/or clinical trials, complete ongoing or future clinical trials in part or at all, receive regulatory approval or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to Vistagen’s ability to pursue and/or secure collaborative support for continued clinical development of AV-101; other risks and uncertainties related to delays in launching, conducting and/or completing ongoing and planned clinical trials; fluctuating costs of materials and other resources and services required to conduct Vistagen’s ongoing and/or planned clinical and nonclinical trials; current and potential future healthcare reforms; market conditions; the impact of general economic, industry or political conditions in
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Investors:
Mark A. McPartland
markmcp@vistagen.com
Media:
Michelle Wellington
mwellington@vistagen.com
Corporate Development:
Reid Adler
radler@vistagen.com
Source: Vistagen
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