buntanetap crystalline (ANVS402) / Annovis Bio - LARVOL DELTA

Annovis Reports Peer-Reviewed Publication Highlighting Pharmacokinetics of Novel Crystal Buntanetap (GlobeNewswire) - "Recently, the Annovis team identified a new dihydrate crystal, which incorporates two moles of water in its structure and offers greater stability. This publication examines how the new crystal form behaves in the body following oral administration, focusing on absorption and clearance. The findings confirm that crystal buntanetap preserves the PK profile and metabolism of the original form, which are essential for the drug’s therapeutic efficacy....The new crystal buntanetap is currently being used in the pivotal Phase 3 clinical trial (NCT06709014) in patients with early AD, which is actively enrolling participants across the U.S. The study is designed to deliver two key readouts: symptomatic (Fall 2026) and disease-modifying (Fall 2027)."

Enrollment status • P3 data • Preclinical • Alzheimer's Disease

Annovis Completes Full Patent Transfer to Crystal Buntanetap (GlobeNewswire) - "Annovis Bio, Inc...announced that all Company’s patents have been successfully transferred from the original form of buntanetap and rewritten to cover the new crystal form. Every patent family is now represented for both forms of the Company’s drug candidate, securing comprehensive protection, which extends to 2046...Building on its foundational patent for the treatment of chronic neurodegenerative conditions, the Company has systematically expanded its coverage to include patents for the use of the original compound. Since then, Annovis has developed a robust IP portfolio which includes patents protecting the composition of matter, mechanism of action, applications of buntanetap for multiple indications, and its combination with other drugs."

Patent • Parkinson's Disease

Annovis Bio Receives FDA Approval to Transition to New Crystal Form of Buntanetap (GlobeNewswire) - "Annovis Bio Inc...announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to transition to a new solid form of buntanetap in future clinical trials...The Company conducted comprehensive bridge studies in various solvents and in animals, comparing the old semi-crystalline form with the new crystalline form of buntanetap. Additionally, Annovis developed an innovative large-scale manufacturing process for the new form. This comprehensive data was submitted to the FDA for review...This positive response allows Annovis to conduct a comparative study between the old and new forms of buntanetap in a small, single-dose, bioavailability study in humans as part of the transition process."

FDA event • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Annovis Bio Files Provisional Patent for New Manufacturing Process of Crystalline Form of Buntanetap (GlobeNewswire) - "Annovis Bio Inc...announced today the filing of a provisional patent covering the manufacturing process of new solid forms of buntanetap. This patent encompasses the methods for manufacturing the new crystalline form of buntanetap (CAS# 3032752-92-1), which has demonstrated exceptional stability and efficacy. The patent also covers the entire synthesis process, from basic starting materials to finished (>99.9% pure) GMP product, suitable for manufacturing scale at ton quantities...The CMC protocol was submitted to the FDA and will be discussed in July, with the goal of continuing development of our drug and filing the NDA with the new crystal form."

FDA event • Patent • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Annovis Bio Files Patent for New Composition of Matter for Buntanetap (GlobeNewswire) - "nnovis Bio Inc...announces the filing of the new composition of matter patent with the U.S. Patent and Trademark Office covering novel solid forms of buntanetap, selecting the best crystal, and building upon the provisional patent filed in June 2023. This patent covers novel crystalline forms of buntanetap and their use for treating and/or preventing various neurodegenerative conditions....The most stable crystal form of buntanetap (CAS# 3032752-92-1) has been selected as the new lead compound for animal bridge studies and for developing a manufacturing process. The bridge studies were submitted to the FDA and will be discussed in July. The goal is to continue development of our drug and file the NDA with the new crystal form."

NDA • Patent • Alzheimer's Disease • CNS Disorders • Parkinson's Disease

Annovis Bio Announces Second Quarter 2023 Financial Results and Provides Corporate Update (Businesswire) - "Cash and cash equivalents were $15.7 million. Research and development expenses for the quarter were $8.2 million, compared to $4.0 million for the same period in 2022. The increase was primarily the result of an increase of $4.2 million in clinical expenses, as Annovis incurred costs related to its phase III study in early Parkinson’s Disease (PD) and its phase II/III Alzheimer's Disease (AD) study."

Commercial • Alzheimer's Disease • CNS Disorders • Parkinson's Disease • Tauopathies And Synucleinopathies

Annovis Bio Announces the Filing of a Groundbreaking Patent (Businesswire) - "Annovis Bio...announces the creation of a novel crystalline form of buntanetap (ANVS402), and the filing of a new composition of matter provisional patent with the U.S. Patent and Trademark Office....Currently, Annovis is conducting ongoing clinical trials of its lead drug candidate buntanetap: a phase III study is testing the medication in early Parkinson’s Disease, and a phase II/III study is testing the medication in moderate Alzheimer’s Disease. ANVS402 is expected to replace buntanetap in future PD and AD clinical trials after completion of a bridging study in early 2024. In addition, the phase III Parkinson’s Disease study recently received a positive safety review from the Data and Safety Monitoring Board (DSMB)."

DSMB • Patent • Trial status • Alzheimer's Disease • CNS Disorders • Parkinson's Disease