MIRA Pharmaceuticals Showcases Significant Progress and Announces Final Phase of Regulatory Work as It Prepares for IND Submission by Year-End
MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) has made significant progress in its drug development programs, particularly with its novel oral ketamine analog, Ketamir-2. The company has enhanced its leadership by appointing Dr. Itzchak Angel as Chief Scientific Advisor. Recent preclinical studies have shown that Ketamir-2 offers a superior safety profile compared to traditional ketamine, with potential applications in treating depression, anxiety, and PTSD.
MIRA has also advanced its MIRA-55 program, a novel oral pharmaceutical marijuana analog, which has demonstrated higher efficacy at cannabinoid receptors compared to THC. The company is finalizing its Investigational New Drug (IND) application for Ketamir-2, with plans to submit by year-end. This progress positions MIRA to potentially transform patient care in neurological and neuropsychiatric disorders with innovative, at-home treatment options.
MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) ha fatto notevoli progressi nei suoi programmi di sviluppo farmaceutico, in particolare con il suo nuovo analogo orale della ketamina, Ketamir-2. L'azienda ha rafforzato la sua leadership nominando il Dr. Itzchak Angel come Chief Scientific Advisor. Studi preclinici recenti hanno dimostrato che Ketamir-2 offre un profilo di sicurezza superiore rispetto alla ketamina tradizionale, con potenziali applicazioni nel trattamento della depressione, dell'ansia e del PTSD.
MIRA ha anche avanzato il suo programma MIRA-55, un nuovo analogo orale della marijuana farmaceutica, che ha dimostrato una maggiore efficacia nei recettori cannabinoidi rispetto al THC. L'azienda sta finalizzando la sua domanda di Nuovo Farmaco Sperimentale (IND) per Ketamir-2, con l'intenzione di presentarla entro la fine dell'anno. Questo progresso posiziona MIRA per trasformare potenzialmente l'assistenza ai pazienti nei disturbi neurologici e neuropsichiatrici con opzioni innovative di trattamento a casa.
MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) ha realizado avances significativos en sus programas de desarrollo de medicamentos, especialmente con su nuevo análogo oral de ketamina, Ketamir-2. La empresa ha fortalecido su liderazgo nombrando al Dr. Itzchak Angel como Asesor Científico Principal. Los estudios preclínicos recientes han mostrado que Ketamir-2 ofrece un perfil de seguridad superior en comparación con la ketamina tradicional, con aplicaciones potenciales en el tratamiento de la depresión, la ansiedad y el PTSD.
MIRA también ha avanzado en su programa MIRA-55, un nuevo análogo oral de marihuana farmacéutica, que ha demostrado una mayor eficacia en receptores cannabinoides en comparación con el THC. La empresa está finalizando su solicitud de Nuevo Medicamento en Investigación (IND) para Ketamir-2, con planes de presentarla para finales de año. Este progreso posiciona a MIRA para transformar potencialmente la atención del paciente en trastornos neurológicos y neuropsiquiátricos con opciones de tratamiento innovadoras en el hogar.
MIRA Pharmaceuticals Inc. (NASDAQ:MIRA)는 특히 새로운 경구 케타민 유사체인 Ketamir-2와 관련하여 약물 개발 프로그램에서 상당한 진전을 이루었습니다. 이 회사는 Dr. Itzchak Angel을 수석 과학 고문으로 임명하여 리더십을 강화했습니다. 최근 전임상 연구는 Ketamir-2가 전통적인 케타민에 비해 우수한 안전성 프로필을 제공하며, 우울증, 불안 및 PTSD 치료에 대한 잠재적 적용 가능성을 보여주고 있습니다.
MIRA는 또한 THC에 비해 카나비노이드 수용체에서 더 높은 효능을 보여주는 새로운 경구 제제 마리화나 유사체인 MIRA-55 프로그램을 발전시켰습니다. 회사는 Ketamir-2에 대한 신약 연구 IND 신청서를 마무리하고 있으며, 연말까지 제출할 계획입니다. 이 진전은 MIRA가 혁신적인 자택 치료 옵션을 통해 신경학적 및 정신신경 장애 환자 치료를 잠재적으로 변형할 수 있는 위치에 있습니다.
MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) a réalisé des progrès significatifs dans ses programmes de développement de médicaments, en particulier avec son analogue oral de kétamine novateur, Ketamir-2. L'entreprise a renforcé son leadership en nommant le Dr Itzchak Angel comme Conseiller scientifique principal. Des études précliniques récentes ont montré que Ketamir-2 offre un profil de sécurité supérieur par rapport à la kétamine traditionnelle, avec des applications potentielles dans le traitement de la dépression, de l'anxiété et du PTSD.
MIRA a également avancé dans son programme MIRA-55, un nouvel analogue oral de marijuana thérapeutique, qui a démontré une efficacité supérieure sur les récepteurs cannabinoïdes par rapport au THC. L'entreprise finalise sa demande de nouveau médicament expérimental (IND) pour Ketamir-2, avec des projets de soumission d'ici la fin de l'année. Cette avancée positionne MIRA pour transformer potentiellement les soins aux patients atteints de troubles neurologiques et neuropsychiatriques grâce à des options de traitement innovantes à domicile.
MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) hat erhebliche Fortschritte in seinen Medikamentenentwicklungsprogrammen gemacht, insbesondere mit seinem neuen oralen Ketamin-Analogen, Ketamir-2. Das Unternehmen hat seine Führung gestärkt, indem Dr. Itzchak Angel zum Chief Scientific Advisor ernannt wurde. Jüngste präklinische Studien haben gezeigt, dass Ketamir-2 ein überlegenes Sicherheitsprofil im Vergleich zu herkömmlichem Ketamin bietet, mit potenziellen Anwendungen zur Behandlung von Depressionen, Angstzuständen und PTSD.
MIRA hat auch sein Programm MIRA-55 vorangetrieben, ein neues orales pharmazeutisches Marihuana-Analog, das eine höhere Wirksamkeit an Cannabinoid-Rezeptoren im Vergleich zu THC gezeigt hat. Das Unternehmen finalisiert seine Investigational New Drug (IND) Antrag für Ketamir-2 und plant, diesen bis zum Jahresende einzureichen. Dieser Fortschritt positioniert MIRA genau, um möglicherweise die Patientenversorgung bei neurologischen und neuropsychiatrischen Störungen mit innovativen, häuslichen Behandlungsoptionen zu revolutionieren.
- Appointment of Dr. Itzchak Angel as Chief Scientific Advisor, bringing 40 years of industry experience
- Ketamir-2 demonstrated superior safety profile compared to traditional ketamine in preclinical studies
- Ketamir-2 showed significant dose-dependent effects in animal models of anxiety and depression
- Development of Ketamir-2 Pamoate salt form with improved pharmacokinetics
- MIRA-55 determined not to be a controlled substance by DEA, removing regulatory barriers
- MIRA-55 exhibited higher efficacy at CB1 and CB2 receptors compared to THC in recent tests
- Progress towards IND submission for Ketamir-2 by year-end
- No clinical trial data available yet for Ketamir-2 or MIRA-55
- Potential regulatory challenges in transitioning from preclinical to clinical stage
Insights
MIRA Pharmaceuticals' progress with Ketamir-2 is noteworthy. The compound's superior safety profile and selective NMDA receptor inhibition could potentially revolutionize mental health treatments. The non-substrate status for P-glycoprotein is a significant advantage, potentially leading to higher efficacy at lower doses. The discovery of Nor-Ketamir as a long-acting metabolite with high oral bioavailability is particularly promising for extended therapeutic efficacy.
The minimal toxicity observed in animal studies, even at high doses, is encouraging. However, it's important to remember that animal studies don't always translate directly to human outcomes. The potential for at-home treatment of neurological and neuropsychiatric disorders could be a game-changer if proven effective in human trials.
MIRA's approach with Ketamir-2 and MIRA-55 demonstrates strategic positioning in the competitive neuropsychiatric drug market. The robust manufacturing process for Ketamir-2, allowing large-scale synthesis with low cost of goods, is a significant advantage for future commercialization. The DEA's determination that MIRA-55 is not a controlled substance removes a major regulatory hurdle, potentially accelerating its development timeline.
The company's exploration of accelerated clinical trial pathways, including orphan indications, shows a savvy approach to potentially faster market entry. However, investors should note that the road from preclinical to approved drug is long and fraught with challenges. The upcoming IND submission will be a critical milestone to watch, as it will determine the timeline for human trials.
From a financial perspective, MIRA Pharmaceuticals' progress is promising but comes with caveats. The company's focus on developing drugs with improved safety profiles and potential for at-home administration could translate to significant market demand if approved. The low cost of goods for Ketamir-2 production is particularly attractive for potential profit margins.
However, investors should be cautious. As a pre-clinical stage company, MIRA faces substantial risks. The costs associated with clinical trials and regulatory approvals can be enormous and success is not guaranteed. The company's cash position and burn rate will be critical metrics to watch. While the scientific progress is encouraging, it's important to remember that many promising drug candidates fail in later stages of development. Investors should carefully consider their risk tolerance before making investment decisions.
MIAMI, FL / ACCESSWIRE / August 19, 2024 / MIRA Pharmaceuticals Inc. (NASDAQ:MIRA) "MIRA" or the "Company"), a leading pre-clinical-stage pharmaceutical company, is pleased to provide a comprehensive update on its recent achievements and scientific advancements as it nears a crucial milestone: the submission of its Investigational New Drug (IND) application by the end of the year. This update highlights the company's strategic progress, significant scientific breakthroughs, and the expertise driving its innovative drug candidates toward clinical trials.
Recent Company Highlights
Leadership Enhancement with Dr. Itzchak Angel
MIRA has strengthened its leadership by appointing Dr. Itzchak Angel as Chief Scientific Advisor. With over 40 years of experience, including a distinguished career at Synthelabo (now Sanofi-Aventis), Dr. Angel was instrumental in the development and regulatory approval of several key drugs, such as Ambien, Xatral and Mizolen. His expertise in advancing drug candidates from early research through clinical trials is now guiding MIRA's pipeline.Scientific Progress with Ketamir-2
MIRA has made significant strides with its novel oral ketamine analog, Ketamir-2. The Company has established a robust manufacturing process for the compound, which allows large-scale, high-quality synthesis with low cost of goods. Recent preclinical studies have demonstrated that Ketamir-2 offers a superior safety profile compared to traditional ketamine, notably avoiding hyper-locomotor activity-a behavior linked to psychotic symptoms-thereby positioning it as a potentially safer option for mental health treatments. The Company has further explored the pharmacological profile of the compound in animal models of anxiety and depression. Significant dose-depended effects were observed upon oral administration of the compound to mice in models such as Elevated Plus Maze, Open Filed and Forced Swim Tests.
The Company's key discoveries include Ketamir-2's non-substrate status for P-glycoprotein (P-gp), which allows for better oral absorption and improved passage through the blood-brain barrier, and potentially higher efficacy at lower doses. Further analysis has shown that Ketamir-2 selectively inhibits the NMDA receptor at the PCP-binding site with 30-50 times lower affinity than traditional ketamine, reducing the risk of side effects such as dissociation and hallucinations.
In addition to these findings, MIRA recently unveiled new data on Ketamir-2's principal metabolite, Nor-Ketamir, which demonstrates a longer-acting, brain-penetrating profile. Nor-Ketamir has shown nearly
The safety profile of Ketamir-2 has been further validated in toxicology studies in mice, rats and dogs, where minimal toxicity was observed at very high doses in animal models. This robust safety data, combined with its strong antidepressant and anxiolytic activities at lower doses, positions Ketamir-2 as a potentially transformative treatment for conditions such as depression, treatment-resistant depression (TRD), and post-traumatic stress disorder (PTSD).
Regulatory Milestone for MIRA-55
MIRA-55, the Company's novel oral pharmaceutical marijuana analog, continues to show promising results in preclinical studies, demonstrating significant advantages over THC. Recent tests confirmed that MIRA-55 exhibits higher efficacy at both the CB1 and CB2 cannabinoid receptors compared to THC, with a more pronounced and sustained increase in agonist activity. This indicates MIRA-55's potential for greater effectiveness in treating anxiety, cognitive decline, and other neurological conditions. Moreover, MIRA-55 maintains a consistent anxiolytic effect across a broader range of doses without losing effectiveness, unlike THC. The DEA's determination that MIRA-55 is not a controlled substance removes significant regulatory barriers, enabling the company to advance its development as a safer, more effective treatment for various neuropsychiatric disorders.
Ongoing Activities and Future Plans
MIRA Pharmaceuticals is finalizing its IND application for Ketamir-2, focusing on scaling up Good Manufacturing Practice (GMP) processes and completing Chemistry, Manufacturing, and Controls (CMC) documentation. Additionally, MIRA has initiated the final stage in its regulatory safety studies, a critical step towards ensuring the safety and efficacy of Ketamir-2 in preparation for clinical trials. The company is also exploring accelerated clinical trial pathways, such as orphan indications or cancer-related indications, which could provide faster access to clinical trials and bring Ketamir-2 to patients sooner. MIRA continues to work with research organizations like Pharmaseed and Biotrial to further validate Ketamir-2's efficacy and safety, with additional studies targeting conditions such as PTSD and neuropathic pain.
Quote from Chairman and CEO
"Our mission at MIRA Pharmaceuticals is to bring easy access, affordable, and safer drugs to those suffering from neurological and neuropsychiatric disorders. The latest advancements with Ketamir-2 and MIRA-55 reinforce our commitment to transforming patient care by offering innovative treatments that can be effectively administered at home. We remain dedicated to pushing the boundaries of what's possible in drug development to ensure that patients have access to the best possible therapies," said Erez Aminov, Chairman and CEO of MIRA Pharmaceuticals.
About MIRA Pharmaceuticals
MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. MIRA holds the exclusive U.S., Canadian and Mexican rights for Ketamir-2, a novel, patent pending oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression, major depressive disorder with suicidal ideation and post-traumatic stress disorder. The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations.
In addition, MIRA's novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from neuropathic pain as well as anxiety and cognitive decline, often associated with early-stage dementia. MIRA-55, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders. The U.S. Drug Enforcement Administration's scientific review of MIRA-55 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. Additional information about MIRA Pharmaceuticals is available at: www.mirapharmaceuticals.com
Ketamir-2 and MIRA-55 are in early-stage preclinical development. There is no assurance that the products will proceed through development or will receive FDA approval for marketing.
Cautionary Note Regarding Forward-Looking Statements
This press release and the statements of MIRA Pharmaceuticals' (or the "Company") management related thereto contains "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the study results described herein as well as the timing for the Company's other preclinical studies and the filing of an IND for Ketamir-2. Any forward-looking statements in this press release are based on the Company's current expectations, estimates and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond the Company's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning the Company's programs and operations are described in additional detail in Annual Report on Form 10-K for the year ended December 31, 2023 and other SEC filings, which are on file with the SEC at www.sec.gov and the Company's website at https://www.mirapharmaceuticals.com/investors/sec-filings. The Company explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.
Contact Information
Helga Moya
info@mirapharma.com
(786) 432-9792
SOURCE: Mira Pharmaceuticals Inc.
View the original press release on accesswire.com
FAQ
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