exenatide high dose implant (NPM-115) / Vivani Medical - LARVOL DELTA

LIBERATE-1: Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Vivani Medical, Inc | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

LIBERATE-1 Study Results (GlobeNewswire) - P1 | N=24 | LIBERATE-1 (NCT05670379) | Sponsor: Vivani Medical, Inc | "The LIBERATE-1 Phase 1 study successfully met its primary objectives, which were to evaluate the NPM-115 implant’s safety and tolerability profile and to characterize the pharmacokinetic (PK) profile of the implant over a 9-week duration. Throughout the study, the implant was generally well tolerated, and drug release from the implant without any clinically meaningful burst was supported by PK analysis and by the absence of gastrointestinal adverse events in subjects with the implant. No serious adverse events were observed in the study."

P1 data • PK/PD data • Obesity

Vivani Medical Provides Business Update Including $3M Equity Financing and Reports First Quarter 2025 Financial Results (GlobeNewswire) - "Upcoming Anticipated Milestones: Vivani anticipates top-line data from the LIBERATE-1 study in mid-2025. LIBERATE-1 is a Phase 1 study of a miniature, ultra long-acting GLP-1 (exenatide) implant to investigate the safety, tolerability and full pharmacokinetic profile in obese or overweight subjects."

P1 data • Obesity

Vivani Medical Announces $8.25M Private Placement Equity Financing (GlobeNewswire) - "The Company expects the gross proceeds from this private placement to extend its cash runway into the second quarter of 2026, enabling accelerated development of NPM-139, its once or twice-yearly GLP-1 (semaglutide) implant under development for chronic weight management, and continued development of NPM-115, its twice-yearly GLP-1 (exenatide) implant which is also under development for chronic weight management."

Financing • Obesity

Vivani Medical Achieves First Implant and Full Enrollment in the First-in-Human Clinical Trial of GLP-1 Implant NPM-115 in Obese or Overweight Adults (Businesswire) - "Vivani Medical, Inc...today announced the successful administration of its first GLP-1 (exenatide) implant in the LIBERATE-1 clinical trial. This milestone marks a critical step toward addressing one of healthcare’s most pressing challenges: medication adherence in metabolic diseases including chronic weight management and type 2 diabetes. The Company also announced full enrollment in the LIBERATE-1 study, which was achieved in just four weeks after enrollment of the first subject, signaling early potential interest for this six-month, subdermal GLP-1 implant and reaffirming previous estimates that top-line results should be available in mid-2025."

Enrollment closed • P1 data • Trial status • Metabolic Disorders • Obesity

LIBERATE-1: Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Vivani Medical, Inc | Not yet recruiting ➔ Active, not recruiting

Enrollment closed • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Vivani Medical Receives Regulatory Approval to Initiate First in Human Clinical Trial with GLP-1 Implant in Obese and Overweight Individuals in Australia (Businesswire) - "Vivani Medical...announced that the Bellberry Human Research Ethics Committee ('HREC') has approved and the Therapeutic Goods Administration ('TGA') in Australia has formally acknowledged a first in human clinical trial of the Company’s miniature, subdermal GLP-1 (exenatide) implant in obese and overweight subjects. This clinical trial, known as LIBERATE-1, will investigate the safety, tolerability and full pharmacokinetic profile of an exenatide implant and represents the first clinical application of the Company’s proprietary NanoPortal drug implant technology...'Securing regulatory approval keeps us on schedule to initiate this trial in Australia in the fourth quarter of 2024.'...LIBERATE-1 will be a randomized investigation of the safety, tolerability and pharmacokinetic profile of the exenatide NanoPortal implant in obese or overweight subjects....The trial is expected to be initiated later this year with data projected to be available in 2025."

Clinical data • New trial • Metabolic Disorders • Obesity

LIBERATE-1: Assessment of Safety, Tolerability and Drug Levels of Exenatide Implant (clinicaltrials.gov) - P1 | N=24 | Not yet recruiting | Sponsor: Vivani Medical, Inc | N=16 ➔ 24 | Trial completion date: Jan 2025 ➔ Aug 2025 | Trial primary completion date: Jan 2025 ➔ Aug 2025

Enrollment change • Trial completion date • Trial primary completion date • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Vivani Medical Provides Update on Clinical Development Plans for Miniature, Long-term, GLP-1 Obesity Implant Program, NPM-115 (Businesswire) - "Vivani Medical, Inc...today announced that it expects to initiate the first clinical study in the NPM-115 program in the fourth quarter of 2024 in Australia, pending regulatory clearance in that country. The NPM-115 clinical program will evaluate the investigational 6-month GLP-1 implant for chronic weight management in patients who are either obese or overweight with a related comorbidity."

New trial • Metabolic Disorders • Obesity

Vivani Medical Provides Business Update and Reports First Quarter 2024 Financial Results (Businesswire) - "Vivani anticipates filing the NPM-115 IND application in the second half of 2024 and initiating a first-in-human trial after receiving regulatory clearance to proceed. Vivani remains on track to provide the FDA with the requested CMC information associated with the current Clinical Hold on NPM-119 during the first half of 2024. Vivani plans to participate in multiple external events, including the TIDES USA conference on Oligonucleotide and Peptide Therapeutics on May 17, 2024 in Boston, MA, where Dr. Mendelsohn will present new NPM-115 data, as well as the Annual BIO International Conference in San Diego, CA on June 3-5, 2024, where Dr. Mendelsohn and Vivani’s Chief Business Officer Don Dwyer will meet with potential partners, investors and other industry representatives."

Clinical • FDA event • IND • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Vivani Medical Announces Positive NPM-115 Preclinical Weight Loss Data Comparable to Ozempic/Wegovy and Discloses NPM-139 as Semaglutide as Strategy Shifts to Prioritize Obesity Portfolio (Businesswire) - "Vivani Medical, Inc...today announced positive preclinical data on weight loss effects for NPM-115....The Company also disclosed that semaglutide is the active pharmaceutical ingredient in NPM-139....In a study in high-fat diet-induced obese mice, NPM-115 generated weight loss of approximately 20% compared to a sham implant control after a 28-day treatment duration, comparable to weight loss observed in mice treated with semaglutide injections (Ozempic/Wegovy) in the same study....In a second study in healthy rats, a single administration of the Company’s exenatide implant NPM-119, in development for the treatment of type 2 diabetes, resulted in body weights that were approximately 25% lower than a vehicle implant control after 15 weeks of treatment with an expected duration of effect of six months."

Preclinical • Metabolic Disorders • Obesity

Vivani Medical Provides Business Update and Reports Third Quarter Financial Results (Yahoo Finance) - "Vivani is announcing the addition of NPM-115 (high-dose exenatide implant) under development for chronic weight management in obese or overweight patients to its emerging pipeline. Preliminary evidence suggests NPM-115, if successful, may provide another competitive GLP-1 monotherapy treatment option with potential advantages associated with improved medication adherence and tolerability."

Pipeline update • Metabolic Disorders • Obesity