Posiphen (buntanetap) / Annovis Bio - LARVOL DELTA

HOW THE THERAPEUTIC APPROACH TO EARLY PARKINSON'S DISEASE WILL CHANGE IN THE NEXT FUTURE (ADPD 2025) - "Levodopa remains the most efficacious drug, a better preparation of levodopa like IPX 203 can ensure more stable plasma levels of Levodopa...Tavapadon is a new dopamine agonist stimulating D1-D5 receptors which concluded the phase III. Other compounds such as CVN424 (Cerevance) orally active and selective GPR6 inverse agonist, piperamat (IRLAB 752) a cortical enhancer to improve balance, Clenbuterol/Nadolol for cognition, mesdopetam a D3 antagonist are under investigation...These include the monoclonal antibody prasinezumab, UCB0599 and buntanetap small-molecules α-synuclein aggregation inhibitor, the vaccine ACI-7104.056 by AC immune...The LRKK2 kinase inhibitor BIIB122/DNL151 is in phase IIb in PD. BIAL BIA 28-6156 activator of the GCase enzyme is under investigation in patients with GBA mutation. The combination of symptomatic and disease modifying therapy, the use of accurate biomarkers and more precise treatment will be the future in the treatment of PD."

CNS Disorders • Movement Disorders • Parkinson's Disease • GBA

APOE4 AND BUNTANETAP IN PHASE II/III ALZHEIMER'S PATIENTS (ADPD 2025) - "We will conduct an additional phase III study in biomarker-positive mild AD patients for 6-month to confirm the safety, efficacy, and symptomatic efficacy of buntanetap and an 18-month study to show potential disease-modification. We further want to evaluate the relation of buntanetap with APOE4 carriers and non-carriers."

Clinical • P2/3 data • Alzheimer's Disease • CNS Disorders • Inflammation • APOE • APP • TARDBP

BUNTANETAP IMPROVES EARLY PARKINSON'S PATIENTS' COGNITION AND MOTOR FUNCTIONS IN A PHASE 3 STUDY (ADPD 2025) - P1/2, P3 | "Buntanetap promises to be the first drug to improve both cognitive and motor functions in PD patients and improve cognition in AD patients. The company plans to submit the data to the FDA to agree on a path forward to NDA."

Clinical • P3 data • Alzheimer's Disease • CNS Disorders • Dementia • Movement Disorders • Parkinson's Disease

Annovis to Attend AD/PD 2025 with Extensive Scientific Program (GlobeNewswire) - "'At this meeting, we will present comprehensive data from our latest Phase 3 PD and Phase 2/3 AD studies. For Parkinson’s, we will take a deeper look into the cognitive response, while for Alzheimer’s, we will dive into the advantages of buntanetap for APOE4 carriers, addressing a pressing challenge in existing AD therapies'."

Clinical data • Alzheimer's Disease • Parkinson's Disease

Annovis Joins Experts at Drug Development Summit to Redefine Parkinson's Treatment (GlobeNewswire) - "Annovis Bio Inc...will participate at the 13th Alzheimer’s & Parkinson’s Drug Development Summit happening on March 18-20 in Boston, MA....'We will present the lessons learned from our AD and PD clinical trials, delve into buntanetap’s mechanism of targeting alpha-synuclein, and discuss ways to usher in a new era for Parkinson’s treatment'."

Clinical data • Parkinson's Disease

Annovis to Present at Oppenheimer’s 35th Annual Healthcare Life Sciences Conference (GlobeNewswire) - "Annovis Bio Inc...today announced that its CEO, Maria Maccecchini, Ph.D., will present at the Oppenheimer's 35th Annual Healthcare Life Sciences Conference...Dr. Maccecchini will discuss the Company’s latest advancements, highlighting the progress of the pivotal Phase 3 trial in early AD and strategic initiatives toward a New Drug Application (NDA) for buntanetap as both a symptomatic and potentially disease-modifying treatment."

Trial status • Alzheimer's Disease

A Double-blind Dual Study Assessing Safety and Efficacy of Buntanetap in Participants with Early AD (clinicaltrials.gov) - P3 | N=760 | Recruiting | Sponsor: Annovis Bio Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders

Annovis Announces First Patients Entered into Pivotal Phase 3 Study of Buntanetap for Early Alzheimer’s Disease (GlobeNewswire) - "Annovis Bio Inc...today announced that the first two patients have been entered into the pivotal Phase 3 study evaluating buntanetap in early AD....Annovis anticipates enrolling over 750 participants across ~100 sites in the United States."

Trial status • Alzheimer's Disease

Annovis Bio, Inc. Announces Proposed Public Offering (GlobeNewswire) - "Annovis Bio, Inc...today announced that it intends to offer to sell common stock and warrants in an underwritten public offering. All of the common stock and warrants are to be sold by the Company....The Company intends to use the net proceeds from the offering primarily for working capital and general corporate purposes, including the continued clinical development of the Company’s lead compound, Buntanetap."

Financing • Alzheimer's Disease • CNS Disorders

Annovis Granted U.S. Patent for Treatment and Prevention of Acute Brain or Nerve Injuries Securing Global Protection (GlobeNewswire) - "Annovis Bio Inc...today announced it was granted the U.S. patent covering methods for the treatment and prevention of acute brain or nerve injuries using buntanetap. This newly issued patent is based on buntanetap’s ability to reduce neurotoxicity and mitigate neurodegenerative processes, which can be applicable to such conditions as stroke, ischemia, traumatic brain injury, micro infarcts, and other forms of acute injuries. The patent has already been granted in the EU, Japan, and worldwide."

Patent • CNS Disorders

FDA Accepts Final Protocol for Pivotal Phase 3 Alzheimer’s Disease Study, Streamlining Development Pathway (GlobeNewswire) - "Annovis Bio Inc...today announced that the FDA has accepted an updated protocol for the pivotal Phase 3 AD study, which is slated to begin in January 2025."

FDA event • New P3 trial • Alzheimer's Disease

Developing Topics. (PubMed, Alzheimers Dement) - "This short study shows a symptomatic effect with a possible disease-modification trend according to the tau data. The next study will have a longer duration, improved design and be statistically powered to validate symptomatic improvement and disease-modification."

Clinical • Journal • Alzheimer's Disease • CNS Disorders • Inflammation • APP

A 6-month & 18-month Randomized Dual Study Assessing Safety and Efficacy of Buntanetap in Participants with Early AD (clinicaltrials.gov) - P3 | N=760 | Not yet recruiting | Sponsor: Annovis Bio Inc.

New P3 trial • Alzheimer's Disease • CNS Disorders

Annovis Bio Reports Third Quarter Financial Results and Provides Business Update (GlobeNewswire) - "Clinical Updates...The 6-month symptomatic study is expected to begin in Q1 2025...The company has an adequate runway for all Phase 3 preparatory studies and for entering the pivotal Phase 3 AD study in Q1 2025."

Commercial • New P3 trial • Alzheimer's Disease • CNS Disorders

Annovis to Highlight Buntanetap’s Alzheimer’s Research Progress with Presentations at CTAD 2024 (GlobeNewswire) - "Annovis Bio Inc...today announced it will present two scientific posters at the 17th Clinical Trials on Alzheimer’s Disease (CTAD) conference. The event will be held from October 29 to November 1, 2024, in Madrid, Spain."

Biomarker • P2/3 data • Alzheimer's Disease • CNS Disorders

Biomarker data showed buntanetap reduced neurotoxic proteins, improved axonal integrity, reduced inflammation, and neuronal functions in Alzheimer's clinical studies. (CTAD 2024) - No abstract available

Biomarker • Clinical • Late-breaking abstract • Alzheimer's Disease • CNS Disorders • Inflammation

APOE4 and Buntanetap in Phase II/III Alzheimer's patients (CTAD 2024) - No abstract available

Clinical • Late-breaking abstract • P2/3 data • Alzheimer's Disease • CNS Disorders

FDA Clears Annovis to Launch Pivotal Phase 3 Alzheimer’s Studies, Paving the Way to NDAs (GlobeNewswire) - "Annovis Bio Inc...announced today the successful outcome of the End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on October 10, 2024. During the meeting, the FDA granted clearance to proceed with pivotal Phase 3 studies, based on the Company's Phase 2/3 clinical data showing symptomatic improvement in early AD patients. Annovis and the FDA have now aligned on a development path for buntanetap towards the filing of New Drug Applications (NDAs), one for short-term and one for long-term efficacy...'Our team is already preparing for trial initiation early next year and will continue to keep you updated as we advance towards our goal.'"

FDA event • New P3 trial • Alzheimer's Disease • CNS Disorders

Annovis Files Three New Patents for Combination Therapies Involving Buntanetap, Trulicity, and Viagra (Annovis Bio Press Release) - "Annovis Bio Inc...today announced the filing of three new patents for innovative combination therapies involving its lead compound, buntanetap. These patents cover combinations of buntanetap with Trulicity (dulaglutide), Viagra (sildenafil), or a combination of all three, creating a multifaceted approach to treating neurodegenerative diseases...Recent preclinical studies have demonstrated that when buntanetap is combined with a GLP-1 agonist (such as Trulicity) or PDE5 inhibitors (such as Viagra), cognitive function in Alzheimer’s mouse models improves to levels beyond those observed in healthy controls...By leveraging the proven efficacy of Trulicity and Viagra in combination with buntanetap, Annovis is expanding its pipeline and advancing its mission to enhance cognition for those suffering from neurodegenerative disorders."

Patent • Alzheimer's Disease • CNS Disorders

Gastroretentive Delivery Approach to Address pH-Dependent Degradation of (+)- and (-)-Phenserine. (PubMed, AAPS PharmSciTech) - "In comparison, a traditional hydrophilic-matrix, extended-release tablet showed measurable amounts of phenserine degradation in a pH 7.2 medium over an 8 h release interval. These results confirm that a gastroretentive tablet can reduce the luminal degradation of phenserine or posiphen by limiting exposure to neutral pH conditions while providing sustained release of the drug over at least 12 h. Additional advantages of the gastroretentive tablet include reduced gastric and intestinal concentrations of the drug resulting from the slower release from the gastroretentive tablet which may also limit the occurrence of the dose-limiting GI side effects previously observed with immediate-release phenserine capsules."

Journal • Alzheimer's Disease • CNS Disorders • Movement Disorders • Parkinson's Disease

Annovis Bio Announces New Data from Phase III Parkinson’s Study Highlighting Improvements in Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and Cognition after Treatment with Buntanetap (GlobeNewswire) - P3 | N=523 | NCT05357989 | Sponsor: Annovis Bio Inc. | "Buntanetap stops cognitive decline in all enrolled patients (MMSE 20-30) and improves cognition in patients with mild dementia (MMSE 20-26)...However, in patients diagnosed with PD for longer than 3 years (MH>3), with measurable declines in MDS-UPDRS Part II, 20mg buntanetap significantly improved MDS-UPDRS Part II, Part III, Part II+III, and Total scores compared to placebo and baseline...PIGD patients treated with buntanetap showed significant improvements in MDS-UPDRS Part II, Part III, Part II-III, and Total scores...Buntanetap maintained a consistent safety profile across all participants, with no significant differences between early and advanced PD patients confirming our previous AD data."

P3 data • CNS Disorders • Parkinson's Disease

A multicenter, randomized, double-blind, placebo-controlled ascending dose study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamic (PD) effects of Posiphen in subjects with early Alzheimer's Disease. (PubMed, Alzheimers Res Ther) - P1/2 | "Posiphen was safe and well-tolerated in Early AD. A multicenter SILK study was feasible. Findings are limited by small sample size but provide additional supportive safety and PK data. Comprehensive modeling of biomarker dynamics using SILK data may reveal subtle drug effects."

Biomarker • Clinical • Journal • PK/PD data • Alzheimer's Disease • CNS Disorders • Cognitive Disorders • Pain • Aβ42 • CSF Aβ40 • CSF Aβ42

Annovis Bio Highlights New Alzheimer’s Data at the Alzheimer’s Association International Conference 2024 (GlobeNewswire) - "Annovis Bio Inc...is pleased to announce that it has been selected to present the data from its latest Alzheimer’s study in an extended 45-minute session at the Alzheimer’s Association International Conference 2024 (AAIC). The conference will take place from July 28 to August 1 in Philadelphia, USA, and online. Dr. Cheng Fang...will deliver a 45-minute oral presentation in a Developing Topics session, highlighting the significant findings from the company’s recent studies of Buntanetap in patients with mild AD."

P2/3 data • Alzheimer's Disease • CNS Disorders

Data from Phase2/3 Clinical Study in Mild to Moderate Alzheimer's Disease (AAIC 2024) - "Background: By inhibiting the translation of neurotoxic aggregating proteins - amyloid precursor protein, tau, alpha-synuclein etc., buntanetap restores axonal transport, lowers inflammation, and protects nerve cells from dying... This short study shows a symptomatic effect with a possible disease-modification trend according to the tau data. The next study will have a longer duration, improved design and be statistically powered to validate symptomatic improvement and disease-modification."

Clinical • P2/3 data • Alzheimer's Disease • CNS Disorders • Inflammation • APP

Annovis Bio’s Buntanetap Found Safe and Effective in High-Risk Alzheimer's Patients (GlobeNewswire) - P2/3 | N=320 | NCT05686044 | Sponsor: Annovis Bio Inc | "Annovis Bio Inc...today announces that its recent Phase II/III Alzheimer’s study of its lead drug candidate, Buntanetap, showed statistically significant efficacy and safety in both carriers and non-carriers of Apolipoprotein E4 (APOE4), a genetic cause of AD....In patients with early AD (MMSE 21-24), Buntanetap showed a statistically significant dose-response in ADAS-Cog11 scores, with a -3.3 points improvement over baseline and -2.3 points improvement from placebo. APOE4 Carriers: In APOE4 carriers treated with 15mg Buntanetap, there was a -3.15 improvement in ADAS-Cog11 scores. Comparable Safety: Buntanetap was found to be equally safe in both APOE4 carriers and non-carriers, with no instances of ARIA (Amyloid-Related Imaging Abnormalities)."

P2/3 data • Alzheimer's Disease • CNS Disorders