p75NTR

Plenary presentation of data showing primary efficacy endpoint met – significant analgesia across all dosesSignificant improvement in all signs and symptoms of osteoarthritis for all dosesPoster presentation of imaging data showing no increase in incidence of rapid joint deterioration compared to placeboFirst-in-class novel biologic under development as non-addictive pain treatment SANDWICH, United Kingdom, April 26, 2025 (GLOBE NEWSWIRE) -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis, is presenting key data from its positive Phase II trial of LEVI-04 at the 2025 World Congress on Osteoarthritis (OARSI) in Seoul, South Korea. LEVI-04 is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc) that provides analgesia via inhibition of NT-3 activity, supplementing the endogenous p75NTR binding protein and modulating excess neurotrophin levels present in osteoarthritis. The data being presented at the conference are from Levicept's multiarm, multicentre, randomized, double-blind, placebo-controlled, Phase II study which enrolled 518 participants with pain and disability due to osteoarthritis of the knee (ClinicalTrials.gov ID: NCT05618782). Professor Philip Conaghan, MBBS, PhD, Director NIHR Leeds Biomedical Research Centre, Principal Investigator, has been invited to give a plenary presentation of efficacy data from the trial. LEVI-04 demonstrated significant differences to placebo for the primary endpoint for all doses: The primary endpoint was WOMACi pain assessment (change from baseline at Week 17).More than 50% of the LEVI-04-treated patients reported ≥50% reduction in pain and >35% reported ≥70% reduction at week 17.Secondary endpoints included WOMAC subscales of function and joint stiffness, patient global assessment and daily pain scores and these were all statistically different to placebo.Time to onset of analgesia of 3 to 5 days.LEVI-04 was well tolerated, with no emergent safety concerns. In addition, Professor Ali Guermazi, Boston University, will present the imaging data from the study which showed that LEVI-04 was not associated with deleterious effects on joint structure. There was no increase in the observed incidence of joint-related events at any dose of LEVI-04 compared with placebo, supporting the safety of the novel NT-3 inhibition mechanism of action of LEVI-04. Professor Philip Conaghan said, “We are excited to be presenting these truly exceptional results from a robust and well-designed study at OARSI. Safe and effective pain management is of critical importance in osteoarthritis with existing treatments limited by adverse effects, addiction liabilities and poor efficacy. LEVI-04 demonstrated significant and clinically meaningful improvement in pain, function and other outcomes. “Also, importantly, the imaging data showed that LEVI-04 was not associated with damage to joint structure. Previous analgesic therapies selectively targeting excess neurotrophins have demonstrated analgesia but were associated with significant joint pathologies including rapidly progressive osteoarthritis. We continue to believe LEVI-04 has the potential to offer a vital new treatment option to millions of patients in need.” Eliot Forster, CEO of Levicept, said, “The significant interest in the results of our Phase II results at the highest calibre medical conferences around the world underlines their importance. We are confident that LEVI-04 could represent a genuine, and much needed, breakthrough in the treatment of osteoarthritis. We continue to advance our strategy for LEVI-04’s further development and for ensuring the best opportunity for it to reach the many patients who may benefit.” Presentation details: LEVI-04, a Novel Neurotrophin-3 Inhibitor, Substantially Improves Pain and Function in People with Knee Osteoarthritis: a Randomised Controlled Phase II Trial. Authors: Conaghan, Philip G; Guermazi, Ali; Katz, Nathaniel; Bihlet, Asger R; Rom, Dror; Perkins, C Michael; Hughes, Bernadette; Herholdt, Claire; Bombelka, Iwona; Westbrook, Simon. Presentation: Oral plenary presentation – 26 April 2025, 10:45 - 10:55 AM KST LEVI-04, a novel neurotrophin-3 inhibitor, is not associated with deleterious effects on joint structure in people with knee osteoarthritis: data from a Phase II RCT. Guermazi, Ali; Conaghan, Philip G; Katz, Nathaniel; Bihlet, Asger R; Rom, Dror; Perkins, C Michael; Hughes, Bernadette; Herholdt, Claire; Bombelka, Iwona; Westbrook, Simon. Presentation: Poster #410 – 25 April and 26 April 4:15 – 5:00 PM KST LeviceptEliot Forster, CEO – eliot@levicept.com Media EnquiriesCharles ConsultantsSue Charles - Sue@charles-consultants.com +44 (0)7968 726585Chris Gardner - Chris@CGComms.onmicrosoft.com +44 (0)7956 031077 About Levicept – www.levicept.com Levicept Ltd is a UK-based biotechnology company developing the first in a new class of novel, safe and efficacious biological therapies, LEVI-04 [p75NTR-Fc], for the treatment of osteoarthritis and chronic pain. LEVI-04 inhibits NT-3, one of the neurotrophin family of proteins. LEVI-04 has completed a Phase II clinical trial in more than 500 patients with osteoarthritis. It is estimated that the market opportunity for drugs that treat osteoarthritis is worth in excess of $10 billion. LEVI-04 was discovered by Levicept’s founder, Simon Westbrook. Levicept’s investors include Medicxi, Advent Life Sciences, Gilde Healthcare and Pfizer Ventures. Follow us on LinkedIn - https://www.linkedin.com/company/levicept-ltd _________________________________ i The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale – a recognised standard pain scale

Mindrevive™, composed of extracts of sage and Japanese pagoda tree, found to help enhance mental resilience in older adults MADRID, Feb. 25, 2025 /PRNewswire/ -- A new study illustrates the research journey behind the creation of Monteloeder's latest nootropic formulation Mindrevive™. The study spans the process from laboratory analysis of various botanical candidates to assess and compare their cognitive potential, to a clinical trial of the final selected composition. Sage extract (Salvia officinalis) together with Japanese pagoda tree (Sophora japonica) emerged as the combination with the highest cognitive support potential demonstrating significant improvements in memory, learning and execution in a clinical trial. Continue Reading Two-Phase Study Leads to Monteloeder’s Newest Nootropic for Cognitive Performance The results of this two-in-one study led nutraceutical leader Monteloeder, a subsidiary of SUANNUTRA to create its proprietary "smart supplement" Mindrevive™, designed to help preserve cognitive vitality specifically in adults aged 50 and older who are going through typical age-related changes. Serving the healthy ageing category, the composition targets memory, mental clarity and focus. Specifically, the compounds in Mindrevive™ were found to help: Reduce oxidative stress Increase neuronal survival and regeneration Activate antioxidant defenses Enhance memory and learning Support growth factor release (NGF, BDNF, VEGF) Maintain cognitive health Study Details The two-phase study ushered in a research-driven approach to formulation. Led by Pau Navarro, PhD, published December 2024 in Applied Sciences first involved in vitro analysis of nine unique botanical compounds that were assessed for their nootropic properties. These included water-ethanol extracts of bilberry, blueberry, bacopa (Bacopa monnieri), sage, saffron, rhodiola (Rhodiola rosea), ginkgo biloba, panax ginseng roots, and gotu kola, and, Japanese pagoda tree. These herb extracts were tested in human neural stem cell cultures exposed to oxidative stress. The researchers analyzed each botanical's ability to suppress harmful reactive oxygen and reactive nitrogen species (ROS and RNS), to promote cell survival, and to stimulate neural cell growth factors. Results of this first phase demonstrated that sage standardized in rosmarinic acid exhibited the most noticeable effects on reducing oxidative stress and cell death, while stimulating brain-derived neurotrophic factor (BDNF, a protein involved in in improving brain cell growth and vital for long-term memory and cognitive function). Nerve growth factor (NGF) levels were also increased, a protein associated with neuronal function and maintenance. Additionally, the production of vascular endothelial growth factor (VEGF) was significantly enhanced. VEGF plays a role in supporting healthy circulation, which contributes to oxygen and nutrient delivery to brain cells. When joined with sophora extract enriched to 95% rutin, the BDNF effect was significantly augmented. Rutin is recognized as a powerful antioxidant and helps reduce age-related neuronal degeneration. Moreover AChE (acetylcholinesterase) activity was reduced by more than 60%. High AChE activity is known to impair nerve signaling through the breakdown of acetylcholine, a neurotransmitter crucial for learning, memory, and muscle function. New light shed on Sage's cognitive wellness properties "The nine botanicals selected for analysis are widely recognized for their antioxidant properties and role in supporting cognitive function, with extensive documentation in scientific research," informs Jonathan Jones, Chief Scientific Officer, at Monteloeder. "Some of these ingredients have been evaluated in clinical studies exploring cognitive health. Sage, in particular, has often been overlooked in discussions about cognitive support, yet it stood out in our screening trials. In fact, sage was the only extract to increase the expression of all analyzed factors associated with neuronal function and antioxidant defenses. When combined with rutin, we observed significant enhancements in the production of BDNF, a key molecule involved in brain signaling and cognitive processes. Specifically, it is the major growth factor implicated in memory processes and learning. Research suggests that maintaining optimal BDNF levels is important for overall brain health." Phase Two A subsequent randomized, double-blind placebo-controlled clinical study tested the effects of the chosen composition Mindrevive™ on 121 healthy volunteers aged 50–65 years and suffering from mild cognitive impairment. Assigned to three groups, the participants were given 250mg Mindrevive™, 400mg Mindrevive™, or a placebo every morning after breakfast over a period of 3 months. At six weeks and again at 12 weeks, the participants were assessed through two questionnaires: the MoCA (Montreal Cognitive Assessment), a validated to assess cognitive function, and the ADAS-Cog (Alzheimer's Disease Assessment Scale-Cognitive Subscale), used to evaluate key cognitive parameters such as memory, language, attention, and problem-solving. From Week 6, the 250mg Mindrevive™ dose was shown to contribute to improving short-term memory recall, while the 400mg contributed to improving both short-term memory recall and abstract reasoning after 12 weeks of intake and consistently outperformed the placebo group. The ADAS-Cog test demonstrated significant cognitive improvements with both of the Mindrevive™ doses compared to placebo after 12 weeks. Intragroup analysis showed more pronounced and rapid enhancements with the higher dose. Notably, the supplementation positively impacted language skills at Week 12 and motor skills as soon as Week 6. Individual item analysis revealed improvements in word recall, word recognition, and command performance across both doses. Cognitive health is a growing concern among adults 65 and older, with conditions affecting memory and mental performance ranking among the Top 10 chronic issues, according to the National Council on Aging., recent reports by Future Markets Insights, Inc. forecast cognitive health supplement sales to "experience significant growth," reaching nearly USD17 billion by 2033 at a CAGR of 13.3%. Within this, the market research group predicts the nootropic supplement market to double from USD2.2 billion to USD4.2 billion in that time, at a CAGR of 9.0%. "Cognitive function naturally changes with age" explains Mariana Ortega, Science Marketing Manager of SUANNUTRA. "Mindrevive™ is formulated with clinically studied ingredients to help maintain cognitive performance and support brain health. This is especially relevant for older adults who are proactively looking for natural solutions to preserve mental sharpness and overall well-being." About Monteloeder Monteloeder contributes cutting-edge innovation and scientific rigor to the development of botanical health ingredients, featuring proprietary patented products supported by clinical studies. The company's portfolio has garnered international accolades in wellness, women health, and beauty from within. Monteloeder is a subsidiary of SUANNUTRA, which boasts a rich heritage of more than 125 years of combined experience in the European, US, and Asian nutraceutical sector. Press Contact NutriPR Liat Simha Tel: +972-9-9742893 E-mail: [email protected] Twitter: @NutriPR Website: Company contact Monteloeder, S.L., a subsidiary of SuanNutra Mariana Ortega Science Marketing Manager E-mail: [email protected] Website: Photo: SOURCE Monteloeder, S.L. 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Primary efficacy endpoint met – significant analgesia across all doses Significant improvement in all signs and symptoms of osteoarthritis for all doses Well tolerated with no increase in incidence of rapid joint deterioration compared to placebo First-in-class novel biologic under development as non-addictive pain treatment Oral presentation at 8am EST on 19 November Nov. 14, 2024 -- Levicept Ltd, a biotechnology company focused on the development of LEVI-04, a first-in-class treatment for osteoarthritis, is presenting the results from its positive Phase II trial of LEVI-04 at the American College of Rheumatology's annual meeting, ACR Convergence 2024, being held from 14 November to 19 November, 2024 in Washington, DC. Headline results were first announced in August 2024. LEVI-04 is a proprietary p75 neurotrophin receptor fusion protein (p75NTR-Fc) that provides analgesia via inhibition of NT-3 activity, supplementing the endogenous p75NTR binding protein and modulating excess neurotrophin levels present in osteoarthritis. The data being presented at the conference are from Levicept's multiarm, multicentre, randomized, double-blind, placebo-controlled, Phase II study which enrolled 518 participants with pain and disability due to osteoarthritis of the knee (ClinicalTrials.gov ID: NCT05618782). LEVI-04 demonstrated significant differences to placebo for the primary endpoint for all doses: The primary endpoint was WOMACi pain assessment (change from baseline at Week 17). The mean reduction in WOMAC pain score from baseline was greater than 50% for all three doses of LEVI-04 (0.3mg/kg, 1mg/kg, 2mg/kg) and all statistically different to placebo (pMore than 50% of the LEVI-04-treated patients reported ≥50% reduction in pain and >35% reported ≥70% reduction at week 17. Secondary endpoints included WOMAC subscales of function and joint stiffness, patient global assessment and daily pain scores and these were all statistically different to placebo. Standard safety monitoring plus peripheral nervous system assessments showed LEVI-04 to be well tolerated. There was no increased incidence of SAEs, TEAEs and joint pathologies including rapidly progressive OA compared to placebo as measured via detailed, closely examined, radiographic analysis. Professor Philip Conaghan MBBS PhD, Director NIHR Leeds Biomedical Research Centre, Principal Investigator, who will present the data said, “We believe these are truly exceptional results from a robust and well-designed study. LEVI-04 demonstrated significant and clinically meaningful improvement in pain, function and other outcomes and was well tolerated at all doses studied. “Safe and effective pain management is of critical importance in osteoarthritis with existing treatments limited by adverse effects, addiction liabilities and poor efficacy. These results support the concept of supplementing endogenous p75NTR as a treatment for osteoarthritis, and our belief that LEVI-04 has the potential to offer a vital new treatment option to millions of patients in need.” Eliot Forster, CEO of Levicept, said, “The selection of Levicept’s Phase II results as an oral presentation at ACR Convergence highlights their importance and reinforces our confidence that LEVI-04 could represent a genuine breakthrough in the treatment of osteoarthritis. We are now focused on strategic options to advance LEVI-04’s development and ensuring the best opportunity for it to reach the many patients who may benefit.” Levicept Ltd is a UK-based biotechnology company developing the first in a new class of novel, safe and efficacious biological therapies, LEVI-04 [p75NTR-Fc], for the treatment of osteoarthritis and chronic pain. LEVI-04 inhibits NT-3, one of the neurotrophin family of proteins. LEVI-04 has completed a Phase II clinical trial in more than 500 patients with osteoarthritis. It is estimated that the market opportunity for drugs that treat osteoarthritis is worth in excess of $10 billion. LEVI-04 was discovered by Levicept’s founder, Simon Westbrook. Levicept’s investors include Medicxi, Advent Life Sciences, Gilde Healthcare and Pfizer Ventures. __________ i The Western Ontario and McMaster Universities Osteoarthritis (WOMAC) pain scale – a recognised standard pain scale The content above comes from the network. if any infringement, please contact us to modify.