MIRA Pharmaceuticals’ Post

$MIRA Exciting News from MIRA Pharmaceuticals! We are thrilled to announce groundbreaking preclinical results for our novel oral ketamine analog, Ketamir-2. These findings mark a significant milestone in our journey to revolutionize the treatment of neurological and neuropsychiatric disorders. Key Highlights: ✅ Optimized Brain Delivery: Ketamir-2 has shown enhanced brain penetration by not interacting with P-glycoprotein (P-gp), a common barrier in drug delivery. ✅ Increased Bioavailability: Preclinical studies predict an impressive 80% oral bioavailability, compared to less than 30% for traditional ketamine. ✅ Improved Safety Profile: Ketamir-2 potentially avoids common side effects and dependency risks associated with traditional ketamine, showing no interaction with the mu-opioid receptor. ✅ Convenient Oral Administration: Unlike traditional ketamine, which requires IV administration, Ketamir-2’s oral formulation promises greater patient convenience and compliance. ✅ Promising Therapeutic Potential: Ketamir-2 demonstrates significant antidepressive and anxiolytic effects, and it shows potential for lower dosing with higher efficacy. We are also exploring the potential of Ketamir-2 for treating chemotherapy-induced depression, cancer-related neuropathic pain, and orphan drug indications like multiple sclerosis and Huntington’s disease-induced depression. Please note: The results mentioned are from preclinical studies, and Ketamir-2 & Mira-55 are still under investigation. We are not making any claims regarding its safety or efficacy at this time. Ketamir-2 has not been approved by the FDA, and further studies are necessary to determine its potential for human use. #Mira #Ketamir-2 #Depression #Orphandrug #Pain #Drugdiscovery #Ketamin #FDA #TRD #Suicide #PTSD https://lnkd.in/enUXuFxW

A new contribution from Biotrial's preclinical department to the development of new treatments for psychiatric disorders

There were no surprises when results from the PHOENIX study of Amylyx Pharmaceuticals' ill-fated Relyvrio were presented at the American Academy of Neurology (AAN) annual meeting this week, but details from the confirmatory trial reveal the extent of how poorly the #amyotrophiclateralsclerosis (ALS) drug performed. https://lnkd.in/dPA3mpvF #AAN #ALS #Amylyx #biotechnology #clinicalresearch #clinicaltrials #drugdevelopment #FDA #pharmaceuticals #regulatoryaffairs

𝐒𝐢𝐫𝐧𝐚𝐨𝐦𝐢𝐜𝐬 𝐂𝐨𝐦𝐩𝐥𝐞𝐭𝐞𝐬 𝐈𝐍𝐃-𝐄𝐧𝐚𝐛𝐥𝐢𝐧𝐠 𝐒𝐭𝐮𝐝𝐢𝐞𝐬 𝐟𝐨𝐫 𝐂𝐚𝐫𝐝𝐢𝐨𝐯𝐚𝐬𝐜𝐮𝐥𝐚𝐫 𝐬𝐢𝐑𝐍𝐀 𝐓𝐡𝐞𝐫𝐚𝐩𝐞𝐮𝐭𝐢𝐜 𝐒𝐓𝐏𝟏𝟐𝟓𝐆 Sirnaomics Ltd. (Stock Code: 2257.HK) Sirnaomics, a leading biopharmaceutical company, announced the completion of IND-enabling studies for STP125G, an siRNA therapeutic targeting Apolipoprotein C3 (ApoC3), using its proprietary GalAhead™ mxRNA technology. Safety and efficacy results from non-human primate (NHP) studies support an IND filing with the U.S. FDA to initiate a Phase I clinical study for cardiovascular disease indications. ApoC3 is crucial in triglyceride metabolism and is linked to cardiovascular, metabolic, and neurological disease risks. High triglyceride (TG) levels increase the risk of cardiovascular diseases, and severe hypertriglyceridemia (sHTG) patients are 5 to 10 times more likely to develop acute pancreatitis. siRNA or antisense oligonucleotides targeting ApoC3 have proven effective in lowering TG in sHTG patients. In NHP models (N = 4), STP125G showed dose-dependent silencing activity with a strong safety profile. The maximum target silencing efficacy was achieved at a 10 mg/kg dosage by week 4 and maintained for an additional 9 weeks. Safety evaluations showed excellent results with a single subcutaneous administration at 50 mg/kg, 100 mg/kg, or 250 mg/kg, with silencing efficacies comparable to the 10 mg/kg level. "STP125G is the second drug candidate from our GalAhead™ mxRNA technology showing excellent safety and potent efficacy in NHP models," said Dr. Patrick Lu Patrick Lu, Founder, Chairman, Executive Director, President, and CEO of Sirnaomics. "Its long-lasting silencing activity against ApoC3 may offer better therapeutic benefits for cardiovascular conditions compared to antisense and other siRNA drugs. These data further validate STP125G as a novel siRNA therapeutic candidate for hypertriglyceridemia and other cardiovascular diseases using our proprietary GalAhead™-based delivery technology." #Biopharma #RNAiTherapeutics #CardiovascularHealth #GalAheadTechnology #siRNA #ClinicalTrials #InnovationInMedicine #Hypertriglyceridemia #FDAApproval #MedicalResearch

MIRA Pharmaceuticals is excited to update you on our latest research developments. Currently, MIRA Pharmaceuticals is advancing the preclinical study of Ketamir, a Novel unscheduled oral #ketamine analog, exploring its potential applications in treating Treatment-Resistant Depression (TRD), Major Depression Disorder with Suicidal Ideation (MMDSI), Post-Traumatic Stress Disorder (PTSD), and neuropathic pain. Please stay informed about our rigorous scientific journey by checking out the updated research provided by Zacks Investment Research, which I've attached here. #ketamir #depression #ptsd #cancerpain #neurophathicpain #TRD #ketamine #ketaminetherapy https://lnkd.in/edCheW5J

📢 Breaking News in Medical Research! 📢 Roche and 中外製薬 / Chugai Pharmaceutical Co., Ltd., Ltd. shared updates from the Phase III LUMINESCE study, evaluating Enspryng® (satralizumab) for generalized myasthenia gravis (gMG). While statistically significant data was observed, the results fell short of expectations in terms of clinical benefit. Despite this setback, Enspryng maintains its safety profile and efficacy for neuromyelitis optica spectrum disorder (NMOSD). Roche and Chugai remain committed to exploring Enspryng's potential in various neurological autoimmune and inflammatory diseases, including autoimmune encephalitis, myelin oligodendrocyte glycoprotein-associated disorder, and thyroid eye disease. In light of these findings, shares of multiple drug developers experienced fluctuations, showcasing the dynamic nature of medical research and investment in healthcare innovation. Read more about the study and Enspryng's implications for autoimmune diseases: - https://lnkd.in/eKRrcKbx - https://lnkd.in/eXiXS_sP #MedicalResearch #AutoimmuneDiseases #Enspryng #LUMINESCEStudy #ClinicalTrials #HealthcareInnovation #Roche #ChugaiPharmaceutical #myastheniagravis #innovation

🌟 Exciting news in the realm of dyslipidemia treatment! 🚀 Arrowhead Pharmaceuticals' plozarsiran, now known as ARO-APOC3, has shown remarkable potential in the Phase II SHASTA-2 trial. 📈 Final data reveals an astounding reduction in APOC3 and triglycerides by up to 86% and 90%, respectively. If approved, plozasiran could be a game-changer in addressing critical unmet needs in dyslipidemia management, according to GlobalData. 👩⚕️ Dr. Shireen Mohammad, PhD Cardiovascular & Metabolic Disorders Analyst at GlobalData, emphasizes the urgency of this breakthrough: "There is a critical unmet need for new FCS treatments plozasiran addresses the significant unmet need in the treatment of dyslipidemia." 💊 Patients with SHTG face limited treatment options, making plozasiran's potential even more impactful. https://lnkd.in/dk7Kz6_c #pharma #healthcare #DyslipidemiaTreatment #MedicalBreakthrough

Check out my article mentioned by GlobalData Healthcare

𝐄𝐢𝐬𝐚𝐢 𝐚𝐧𝐝 𝐁𝐢𝐨𝐠𝐞𝐧 𝐀𝐧𝐧𝐨𝐮𝐧𝐜𝐞 𝐅𝐃𝐀 𝐀𝐜𝐜𝐞𝐩𝐭𝐚𝐧𝐜𝐞 𝐨𝐟 𝐬𝐁𝐋𝐀 𝐟𝐨𝐫 𝐌𝐨𝐧𝐭𝐡𝐥𝐲 𝐋𝐄𝐐𝐄𝐌𝐁𝐈® 𝐈𝐕 𝐌𝐚𝐢𝐧𝐭𝐞𝐧𝐚𝐧𝐜𝐞 𝐃𝐨𝐬𝐢𝐧𝐠 Eisai Co., Ltd. Eisai Co., Ltd. and Biogen Inc. Biogen announced that the FDA has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly LEQEMBI® (lecanemab-irmb) IV maintenance dosing. The PDUFA action date is set for January 25, 2025. LEQEMBI is approved for treating Alzheimer’s disease (AD) in patients with mild cognitive impairment or mild dementia. The proposed monthly IV maintenance regimen follows the biweekly IV initiation phase, aiming to maintain effective drug concentration to sustain clearance of toxic protofibrils. This sBLA is based on data from the Phase 2 (Study 201), Clarity AD (Study 301), and their open-label extension studies. AD is a progressive disease caused by toxic amyloid proteins, requiring sustained treatment. Studies show that continued LEQEMBI treatment beyond the 18-month core phase prolongs benefits by continuously removing toxic protofibrils. If approved, this monthly dosing regimen could be less burdensome for patients and caregivers. Additionally, Eisai has initiated a rolling submission of a BLA to the FDA for the LEQEMBI subcutaneous autoinjector for weekly maintenance dosing, granted Fast Track designation in May 2024. LEQEMBI is approved in the U.S., Japan, China, and South Korea, with submissions for review in multiple other countries. Eisai leads global development and regulatory submissions, co-commercializing and co-promoting with Biogen. Protofibrils are the most toxic form of amyloid beta (Aβ) contributing to AD and cognitive decline. Reducing protofibrils may prevent AD progression by reducing neuronal damage. INDICATION: LEQEMBI® (lecanemab-irmb) is indicated for the treatment of Alzheimer’s disease (AD) in patients with #Eisai #Biogen #LEQEMBI #AlzheimersDisease #FDA #ClinicalTrials #Biotech #HealthcareInnovation #Dementia #Pharma #Neurology

Epilepsy, with its unpredictable seizures, not only affects the individual but also burdens families and communities with fear, stigma, and uncertainty. Despite medical advancements, treatment remains a labyrinth of trial and error, with medications often carrying side effects or proving ineffective for some. The quest for effective therapies persists, fueled by the collective efforts of pharmaceutical companies dedicated to innovation and research. Yet, amidst the hurdles, there is hope. Companies such as UCB, Stoke Therapeutics, Xenon Pharmaceuticals Inc., Epygenix Therapeutics, Inc., Bright Minds Biosciences, Neurona Therapeutics, PTC Therapeutics, Inc., Addex Pharmaceuticals Ltd, Équilibre BioPharmaceuticals Corp., Anavex Life Sciences, Eliem Therapeutics, Ovid Therapeutics, CAMP4 Therapeutics, LifeSplice Pharma, Virpax Pharmaceuticals Inc. (Nasdaq:VRPX), Neuroene Therapeutics and others are rallying behind the cause, investing in groundbreaking research and development to discover novel treatments and improve existing therapies. From developing new antiepileptic drugs with improved efficacy and tolerability to exploring innovative seizure management devices and precision medicine approaches, the pharmaceutical industry is at the forefront of driving progress in epilepsy care. In the realm of epilepsy treatment and pharmaceutical development, DelveInsight Business Research LLP at its end plays a role. It serves as an invaluable partner to pharmaceutical giants, providing key insights and strategic guidance that shape the direction of research, development, and marketing efforts. Together, we can transform the landscape of epilepsy treatment, ensuring that no one faces this journey alone and that every individual can live life to the fullest, free from the shackles of seizures. #epilepsyawareness #endepilepsystigma #seizureawareness #epilepsywarrior #supportepilepsy #epilepsyresearch #epilepsycommunity #livingwithepilepsy #epilepsyeducation #epilepsyfighters #epilepsyadvocacy #epilepsyresearch #epilepsyawarenessmonth #epilepsycare #epilepsystrong