Vistagen Receives Notice from European Patent Office of Intention to Grant Patent for AV-101 to Treat Neuropathic Pain
- Positive preclinical data in four well-established pain models demonstrated AV-101's robust effects similar to gabapentin but with a better side effect profile.
- Phase 1 clinical data showed that AV-101 was well-tolerated, with no meaningful difference in adverse events between AV-101 and placebo at any dose tested.
- The European Patent Office issued a Notice of Intention to Grant a patent related to the use of AV-101 for the treatment of neuropathic pain, adding to Vistagen's global patent portfolio on therapeutic uses and manufacturing techniques for AV-101.
- None.
Insights
The issuance of a Notice of Intention to Grant a patent by the European Patent Office for AV-101 marks a significant milestone for Vistagen. This patent protection not only solidifies the company's intellectual property rights but also enhances its competitive edge in the market for neuropathic pain treatments. With a patent life extending until at least 2034, Vistagen secures a long-term commercial exclusivity period, which is crucial for recouping research and development investments and achieving profitability.
Potential investors and stakeholders should note that patent grants in the pharmaceutical industry are a strong indicator of a product's novelty and potential market impact. This is particularly relevant given the global burden of neuropathic pain and the ongoing search for non-opioid treatment alternatives. The protection of the therapeutic uses and manufacturing techniques for AV-101 could also open doors for strategic partnerships and licensing opportunities, which are common avenues for biopharmaceutical companies to accelerate product development and market penetration.
The preclinical data indicating that AV-101 exhibits similar efficacy to gabapentin and pregabalin but with a better side effect profile is promising. This suggests that AV-101 could be positioned as a safer alternative in the pain management market, which is of high interest due to the current opioid crisis and the need for effective non-opioid therapies. The absence of discernable negative side effects in preclinical models is particularly noteworthy, as it may lead to improved patient compliance and outcomes if these results translate to human trials.
Moreover, the Phase 1 clinical data showing AV-101's tolerability and safety profile further supports its potential as a viable therapeutic candidate. While these early-stage studies are not designed for efficacy endpoints, the consistent reductions observed for allodynia pain and hyperalgesia are encouraging signs for its analgesic properties. Investors should monitor subsequent Phase 2 trials closely, as these will provide more definitive efficacy data and could significantly impact Vistagen's valuation and the stock market response.
The announcement regarding AV-101's patent and preclinical data could have implications for Vistagen's financial health and stock performance. The positive preclinical and Phase 1 clinical results may attract investor interest, potentially leading to an increase in the company's stock price as market optimism grows around the drug's prospects. However, investors should exercise caution and consider the inherent risks of drug development, including the possibility of future clinical trials not replicating early-stage results.
Furthermore, Vistagen's intention to seek strategic collaborations could be a double-edged sword. While partnerships could provide necessary capital and expertise to advance AV-101's development, they may also lead to diluted ownership or revenue-sharing arrangements. Investors should evaluate such future collaborations for their terms and potential impact on Vistagen's revenue and profit margins.
Preclinical data in four well-established preclinical models of pain associated with tissue inflammation and nerve injury demonstrate AV-101’s robust effects similar to gabapentin but with a better side effect profile
Phase 1 data demonstrate AV-101 is well-tolerated, with no meaningful difference in adverse events between AV-101 and placebo at any dose tested
AV-101 Preclinical Data in Pain Models
Preclinical data previously published in the peer-reviewed journal, The Journal of Pain,1 demonstrate robust antinociceptive effects, similar to gabapentin, but with a better side effect profile in several preclinical models of hyperalgesia and allodynia. In the study, AV-101 prodrug was systematically administered in four rat models of pain to examine its analgesic and behavioral profile. Dose-dependent anti-hyperalgesia effects were shown in the four models of pain. 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, AV-101 had no discernable negative side effects. The preclinical study was conducted by Tony L. Yaksh, PhD, 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
AV-101 Phase 1 Clinical Data
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. Although 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, MD, Professor of Anesthesiology and Pain Management Specialist at the University of
The preclinical data involving gabapentin and pregabalin, paired with the favorable safety and tolerability profile of AV-101 in all clinical studies completed to date, as well as previously reported positive preclinical results in levodopa-induced dyskinesia (LID) associated with Parkinson’s therapy, demonstrate potential for Phase 2 development of AV-101 as a new non-opioid treatment alternative for multiple CNS disorders.
Vistagen plans to seek potential strategic collaborations to further advance the clinical development and commercialization of AV-101.
About AV-101
AV-101 (4-Cl-KYN) is an investigational oral prodrug of 7-chloro-kynurenic acid (7-Cl-KYNA), a potent and selective full antagonist of the glycine binding site of the NMDAR that modifies the function of the NMDAR. Unlike classic channel-blocking NMDAR antagonists such as ketamine and amantadine, 7-Cl-KYNA is not an ion channel blocker, 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 good oral bioavailability 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 NMDAR antagonists. Moreover, 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
Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting and with fewer side effects and safety concerns than those currently available for the treatment of anxiety, depression, and multiple CNS disorders. Vistagen's pipeline includes six clinical-stage product candidates, including fasedienol (PH94B), itruvone (PH10), PH80, PH15, and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug of an antagonist of the N-methyl-D-aspartate receptor (NMDAR). Pherines are neuroactive nasal sprays designed with an innovative proposed mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic absorption or direct activity on neurons in the brain. Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression, and several other CNS disorders. Connect at www.Vistagen.com.
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
3 Wallace, 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. Among other things, there can be no guarantee that the scope of protection and enforceability provided by any patents issued for any of the Company’s drug candidates, including AV-101, will be sufficient to deter competition, or that any of the Company’s drug candidates, including AV-101, will successfully replicate past preclinical studies and/or clinical trials, complete ongoing or future clinical trials, receive regulatory approval or be commercially successful. Other factors that may cause such a difference include, without limitation, risks and uncertainties relating to the Company’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 the Company’s ongoing and/or planned clinical and nonclinical trials; market conditions; the impact of general economic, industry or political conditions in
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Investors:
Mark McPartland
Senior Vice President, Investor Relations
(650) 577-3606
markmcp@vistagen.com
Media:
Nate Hitchings
SKDK
nhitchings@skdknick.com
Source: Vistagen
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