A Multi-center, Randomized, Double-Blind, Placebo-Controlled Phase ?a Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients with Early Parkinson's Disease

Start Date19 Mar 2020

Sponsor / Collaborator

Peptron, Inc.

NCT04269642 / Unknown statusPhase 2

Phase IIa Study to Evaluate the Efficacy and Safety of Subcutaneous SR-Exenatide (PT320) in Patients With Early Parkinson's Disease

This study is to evaluate the safety and efficacy of sustained release (SR)-Exenatide (PT320, Q1W and Q2W) in the treatment of patients with early Parkinson's disease (PD).

Start Date19 Mar 2020

Sponsor / Collaborator

Peptron, Inc.

NCT03961256 / CompletedPhase 2IIT

A Phase 2, Prospective, Randomized, Multicenter, Open-Label, Controlled Trial to Assess the Efficacy and Safety of Exenatide SR for the Prevention of Diabetes After Kidney Transplantation.

Researchers are trying to determine if an anti-diabetes medication, called Exenatide SR, is well tolerated in kidney transplant patients with elevated blood glucose levels, and if it's effective in preventing diabetes.

Start Date09 May 2019

Sponsor / Collaborator

Mayo Clinic

100 Clinical Results associated with YH-14617

100 Translational Medicine associated with YH-14617

100 Patents (Medical) associated with YH-14617

Literatures (Medical) associated with YH-14617

01 Sep 2024·Neurobiology of Disease

Corrigendum to “Pharmacokinetics and efficacy of PT302, a sustained-release Exenatide formulation, in a murine model of mild traumatic brain injury” [Neurobiology of Disease Volume 124 (2019) 439–453 /YNBDI_4338]

Author: Li, Yazhou ; Rubovitch, Vardit ; Lecca, Daniela ; Kim, Hee Kyung ; Tweedie, David ; Kim, Dong Seok ; Choi, Ho-Il ; Glotfelty, Elliot ; Pick, Chaim G ; Bader, Miaad ; Hoffer, Barry J ; Rachmany, Lital ; Greig, Nigel H

09 Apr 2021·ACS Pharmacology & Translational Science

Sustained Release GLP-1 Agonist PT320 Delays Disease Progression in a Mouse Model of Parkinson’s Disease

Article

Author: Huang, Eagle Yi-Kung ; Greig, Nigel H. ; Lai, Li-Wen ; Jung, Jin ; Ma, Kuo-Hsing ; Chou, Yu-Ching ; Chen, Yuan-Hao ; Kuo, Tung-Tai ; Choi, Doo-Sup ; Choi, Hoi-II ; Li, Yazhou ; Fu, Zhao-Yang ; Wang, Vicki ; Olson, Lars ; Hoffer, Barry J.

GLP-1 agonists have become increasingly interesting as a new Parkinson's disease (PD) clinical treatment strategy. Additional preclinical studies are important to validate this approach and define the disease stage when they are most effective. We hence characterized the efficacy of PT320, a sustained release formulation of the long acting GLP-1 agonist, exenatide, in a progressive PD (MitoPark) mouse model. A clinically translatable biweekly PT320 dose was administered starting at 5 weeks of age and longitudinally evaluated to 24 weeks, and multiple behavioral/cellular parameters were measured. PT320 significantly improved spontaneous locomotor activity and rearing in MitoPark PD mice. "Motivated" behavior also improved, evaluated by accelerating rotarod performance. Behavioral improvement was correlated with enhanced cellular and molecular indices of dopamine (DA) midbrain function. Fast scan cyclic voltammetry demonstrated protection of striatal and nucleus accumbens DA release and reuptake in PT320 treated MitoPark mice. Positron emission tomography showed protection of striatal DA fibers and tyrosine hydroxylase protein expression was augmented by PT320 administration. Early PT320 treatment may hence provide an important neuroprotective therapeutic strategy in PD.

01 Apr 2019·Neurobiology of DiseaseQ2 · MEDICINE

Pharmacokinetics and efficacy of PT302, a sustained-release Exenatide formulation, in a murine model of mild traumatic brain injury

Q2 · MEDICINE

Article

Author: Li, Yazhou ; Rubovitch, Vardit ; Lecca, Daniela ; Kim, Hee Kyung ; Tweedie, David ; Choi, Ho-Il ; Kim, Dong Seok ; Glotfelty, Elliot ; Pick, Chaim G ; Bader, Miaad ; Greig, Nigel H ; Hoffer, Barry J ; Rachmany, Lital

Traumatic brain injury (TBI) is a neurodegenerative disorder for which no effective pharmacological treatment is available. Glucagon-like peptide 1 (GLP-1) analogues such as Exenatide have previously demonstrated neurotrophic and neuroprotective effects in cellular and animal models of TBI. However, chronic or repeated administration was needed for efficacy. In this study, the pharmacokinetics and efficacy of PT302, a clinically available sustained-release Exenatide formulation (SR-Exenatide) were evaluated in a concussive mild (m)TBI mouse model. A single subcutaneous (s.c.) injection of PT302 (0.6, 0.12, and 0.024 mg/kg) was administered and plasma Exenatide concentrations were time-dependently measured over 3 weeks. An initial rapid regulated release of Exenatide in plasma was followed by a secondary phase of sustained-release in a dose-dependent manner. Short- and longer-term (7 and 30 day) cognitive impairments (visual and spatial deficits) induced by weight drop mTBI were mitigated by a single post-injury treatment with Exenatide delivered by s.c. injection of PT302 in clinically translatable doses. Immunohistochemical evaluation of neuronal cell death and inflammatory markers, likewise, cross-validated the neurotrophic and neuroprotective effects of SR-Exenatide in this mouse mTBI model. Exenatide central nervous system concentrations were 1.5% to 2.0% of concomitant plasma levels under steady-state conditions. These data demonstrate a positive beneficial action of PT302 in mTBI. This convenient single, sustained-release dosing regimen also has application for other neurological disorders, such as Alzheimer's disease, Parkinson's disease, multiple system atrophy and multiple sclerosis where prior preclinical studies, likewise, have demonstrated positive Exenatide actions.

News (Medical) associated with YH-14617

20 Apr 2023

·www.prnewswire.com

Parkinson's Disease Clinical Trial Pipeline Space Brims With Novel Emerging Therapies with Over 120 Key Companies Working in the Domain | DelveInsight

Parkinson's disease is a progressive disorder that is caused by the degeneration of nerve cells in the part of the brain called the substantia nigra, which controls movement. These nerve cells die or become impaired, losing the ability to produce an important dopamine chemical. Studies have shown that symptoms of Parkinson's develop in patients with an 80% or greater loss of dopamine-producing cells in the substantia nigra. Most Parkinson's patients are treated with medications to relieve the symptoms of the disease. These medications work by stimulating the remaining cells in the substantia nigra to produce more dopamine (levodopa medications) or by inhibiting some of the acetylcholine that is produced (anticholinergic medications), therefore restoring the balance between the chemicals in the brain. LAS VEGAS, April 19, 2023 /PRNewswire/ -- DelveInsight's ' Parkinson's Disease Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline Parkinson's disease therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Parkinson's disease pipeline domain. Key Takeaways from the Parkinson's Disease Pipeline Report DelveInsight's Parkinson's disease pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for Parkinson's disease treatment. Key Parkinson's disease companies such as Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., NeuroDerm Ltd., Pharma Two B, Serina Therapeutics, Sun Pharma Advanced Research Company Limited, CuraSen Therapeutics, Inc., Takeda, Xoc Pharmaceuticals, Sumitomo Pharma Co., Ltd., XWPharma, Athira Pharma, Aptinyx, VistaGen Therapeutics, Inc., 1ST Biotherapeutics, Inc., Novo Nordisk A/S, AstraZeneca, MedImmune, Anavex Life Sciences Corp., Living Cell Technologies, Intra-Cellular Therapies, Inc., Alkahest, Inc., Kissei Pharmaceutical Co., Ltd., and others are evaluating new Parkinson's disease drugs to improve the treatment landscape. Promising Parkinson's disease pipeline therapies in various stages of development include Tavapadon, IkT-148009, NLY01, PT320, BIIB122, Prasinezumab, KDT-3594, AAV2-GDN, AKST4290, anle138b, ITI-214, NTCELL, Buntanetap, ANAVEX2-73, ATH-1017, NE3107, MEDI1341, AZD0328, Liraglutide, UB-312, LY03003, FB-101, AV-101, ABBV-951, NYX-458, DSP-9632P, Valiloxybate, SER-214, UCB7853, TAK-071, XC130-A10H, K0706, Talineuren, Pirepemat, Lu AF28996, WD-1603, CVN424, CST-103, NBTX-001, MSK-DA01, Aadipose-Derived Mesenchymal Stem Cells, ND0612, P2B001, 1ST-103, 1ST-105, and others. In January 2023, Neurocrine Biosciences and Voyager Therapeutics announced the formation of a new strategic collaboration to advance multiple gene therapies for the treatment of neurological diseases. The collaboration includes Voyager's preclinical, intravenously administered GBA1 gene therapy program for Parkinson's and other GBA1-mediated diseases, combining a GBA1 gene replacement payload with novel capsids from Voyager's TRACERTM (Tropism Redirection of AAV by Cell-type-specific Expression of RNA) platform. In addition, Neurocrine Biosciences and Voyager have agreed to collaborate on three new gene therapy programs directed to rare CNS targets, each also leveraging Voyager's novel TRACER capsids. In October 2022, Biogen Inc. and Denali Therapeutics Inc. announced that dosing has commenced in the global Phase 3 LIGHTHOUSE study to evaluate the efficacy and safety profile of BIIB122 (DNL151), as compared to placebo in approximately 400 participants with Parkinson's disease and a confirmed pathogenic mutation in the leucine-rich repeat kinase 2 (LRRK2) gene. In September 2022, Neuron23, Inc. an early-stage biotechnology company focused on developing precision medicines for genetically defined neurological and immunological diseases, and QIAGEN announced a collaboration to develop a companion diagnostic for Neuron23's LRRK2 inhibitor for Parkinson's disease. Request a sample and discover the recent advances in Parkinson's disease drug treatment @ Parkinson's Disease Pipeline Report The Parkinson's disease pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage Parkinson's disease drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the Parkinson's disease clinical trial landscape. Parkinson's Disease Overview Parkinson's disease is a progressive disorder caused by nerve cell degeneration in the substantia nigra, a part of the brain that controls movement. These nerve cells die or become impaired, losing the ability to produce dopamine, an important chemical. According to research, symptoms of Parkinson's disease develop in patients who have an 80% or greater loss of dopamine-producing cells in the substantia nigra. Dopamine works typically in tandem with other neurotransmitters to help coordinate the millions of nerve and muscle cells involved in the movement. This balance is disrupted when there is insufficient dopamine, resulting in tremors (trembling in the hands, arms, legs, and jaw), rigidity (stiffness of the limbs), slowness of movement, and impaired balance and coordination - the hallmark Parkinson's disease symptoms. The cause of Parkinson's disease is largely unknown. However, as potential causes of the disease, theories involving oxidative damage, environmental toxins, genetic factors, and accelerated aging have been discussed. The majority of Parkinson's patients are given medications to alleviate their symptoms. These Parkinson's disease medications work by either stimulating the remaining cells in the substantia nigra to produce more dopamine (levodopa medications) or inhibiting some of the acetylcholine produced (anticholinergic medications), restoring the balance of chemicals in the brain. Find out more about drugs for Parkinson's disease @ New Parkinson's Disease Drugs A snapshot of the Parkinson's Disease Pipeline Drugs mentioned in the report: Learn more about the emerging Parkinson's disease pipeline therapies @ Parkinson's Disease Clinical Trials Parkinson's Disease Therapeutics Assessment The Parkinson's disease pipeline report proffers an integral view of Parkinson's disease emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Parkinson's Disease Pipeline Report Coverage: Global Parkinson's Disease Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Parkinson's Disease Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Parkinson's Disease Therapeutics Assessment By Route of Administration: Inhalation, Intranasal, Intravenous, Oral, Parenteral, Subcutaneous Parkinson's Disease Therapeutics Assessment By Molecule Type: Antibody, Antisense oligonucleotides, Immunotherapy, Monoclonal antibody, Peptides, Protein, Recombinant protein, Small molecule, Stem Cell, Vaccine Parkinson's Disease Therapeutics Assessment By Mechanism of Action: Dopamine D1 receptor agonists, Dopamine D5 receptor agonists, Bcr-abl tyrosine kinase inhibitors, Glucagon like peptide 1 receptor agonists, LRRK2 protein inhibitors, Alpha-synuclein inhibitors, Dopamine receptor agonists Key Parkinson's Disease Companies: Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, Brain Neurotherapy Bio, Inc., Modag, Annovis Bio Inc., BioVie Inc., United Neuroscience Ltd., Luye Pharma Group, AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., Nobilis Therapeutics Inc., BlueRock Therapeutics, Taiwan Mitochondrion Applied Technology Co., Ltd., NeuroDerm Ltd., Pharma Two B, Serina Therapeutics, Sun Pharma Advanced Research Company Limited, CuraSen Therapeutics, Inc., Takeda, Xoc Pharmaceuticals, Sumitomo Pharma Co., Ltd., XWPharma, Athira Pharma, Aptinyx, VistaGen Therapeutics, Inc., 1ST Biotherapeutics, Inc., Novo Nordisk A/S, AstraZeneca, MedImmune, Anavex Life Sciences Corp., Living Cell Technologies, Intra-Cellular Therapies, Inc., Alkahest, Inc., Kissei Pharmaceutical Co., Ltd., and others. Key Parkinson's Disease Pipeline Therapies: Tavapadon, IkT-148009, NLY01, PT320, BIIB122, Prasinezumab, KDT-3594, AAV2-GDN, AKST4290, anle138b, ITI-214, NTCELL, Buntanetap, ANAVEX2-73, ATH-1017, NE3107, MEDI1341, AZD0328, Liraglutide, UB-312, LY03003, FB-101, AV-101, ABBV-951, NYX-458, DSP-9632P, Valiloxybate, SER-214, UCB7853, TAK-071, XC130-A10H, K0706, Talineuren, Pirepemat, Lu AF28996, WD-1603, CVN424, CST-103, NBTX-001, MSK-DA01, Aadipose-Derived Mesenchymal Stem Cells, ND0612, P2B001, and others. Dive deep into rich insights for new drugs for Parkinson's disease treatment; visit @ Parkinson's Disease Medications Table of Contents For further information on the Parkinson's disease pipeline therapeutics, reach out @ Parkinson's Disease Drug Treatment Related Reports Parkinson's Disease Market Parkinson's Disease Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease companies, including Cerevel Therapeutics, Inhibikase Therapeutics, Neuraly, Peptron, Biogen, Roche, among others. Parkinson's Disease Epidemiology Forecast Parkinson's Disease Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and Parkinson's disease epidemiology trends. Dementia with Lewy Bodies Pipeline Dementia with Lewy Bodies Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key dementia with Lewy bodies companies, including Eli Lilly and Company, CuraSen Therapeutics, Inc., Athira Pharma, Aptinyx Inc., among others. Dementia with Lewy Bodies Epidemiology Forecast Dementia with Lewy Bodies Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted dementia with Lewy bodies epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Dementia Market Dementia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia companies, including Hoffmann-La Roche, Forest Laboratories, Inc., Janssen Pharmaceuticals, Inc., Merck and Co., Inc., Novartis, among others. Parkinson's Disease-Related Dementia Market Parkinson's Disease-Related Dementia Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Parkinson's disease-related dementia companies, including AbbVie, UCB Biopharma SRL, InnoMedica Schweiz AG, Integrative Research Laboratories AB, H. Lundbeck A/S, Shanghai WD Pharmaceutical Co., Ltd., Cerevance Beta, Inc., among others. Other Trending Reports Tay-sachs Disease Or Gm2 Gangliosidosis Market | Onycholysis Market | Diagnostic Imaging Equipment Market | Chemotherapy-induced Peripheral Neuropathy Market | Global Electrophysiology Devices Market | Anaphylaxis Market | Atherectomy Devices Market | Helicobacter Pylori Infections Market | Ophthalmic Imaging Equipment Market | Androgenetic Alopecia Market | Allergic Rhinitis Market | Chronic Inflammatory Demyelinating Polyneuropathy Market | Chronic Inflammtory Demyelinating Polyneuropathy Market | Colorectal Cancer Crc Market | Opioid Induced Constipation Market | Vertigo Market | Bone Anchored Hearing Systems Market | Wound Closure Devices Market | Hip Replacement Devices Market | Hemodynamic Monitoring Systems Market | Egfr Non-small Cell Lung Cancer Market | Helicobacter Pylori Infection Market | Hyperkalemia Market | Polycythemia Market Neurostimulation Devices Market | Carpal Tunnel Syndrome Market | Ventilator Market | Cerebral Aneurysm Market | Alpha Antitrypsin Market | Binge Eating Disorder Market | Bunion Market | Concussions Market Size | Exocrine Pancreatic Insufficiency Market | Healthcare Due Diligence Services | Minimal Residual Disease Market | Hypertrophic Scar Market | Lung Fibrosis Market | Anterior Uveitis Market | 22q11.2 deletion syndrome Market | X-Linked Retinitis Pigmentosa (XLRP) Market | Acute Radiation Syndrome Market | Alpha-1 Protease Inhibitor Deficiency Market | Androgenetic Alopecia Market | Hyperlipidemia Market | Cardiotoxicity Market | Hypertrophic Cardiomyopathy Market | Fatty Acid Oxidation Disorders (FAODs) Market | Androgen Insensitivity Syndrome Market | Emphysema Market | Canaloplasty Market | Dravet Syndrome Market | Celiac Disease Market | Chlamydia Infections Market | Syphilis Market | Renal Tubular Acidosis Market | Palmoplantar Pustulosis (PPP) Market | Aplastic Anemia Market | Bacterial Pneumonia Market | B cell Chronic Lymphocytic Leukemia Market | B cell Lymphomas Market | Behcets Disease Market Neoantigen-based Personalized Cancer therapeutic Vaccines Competitive Landscape and Market Forecast—by 2035 | Glioblastoma Market Related Healthcare Services Healthcare Consulting Healthcare Competitive Intelligence Services Healthcare Asset Prioritization Services About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3

12 Apr 2023

·www.biospace.com

Moderna’s Flu Shot Falls Short of Early Success Threshold

Pictured: Moderna logo on a white building/hapabapa/iStock An interim analysis of Moderna’s Phase III P302 study showed its investigational flu shot, mRNA-1010, fell short of the statistical threshold for early success due to what the company stated was a low number of infected participants. Moderna made the announcement in a pipeline update Tuesday. Despite failing the interim efficacy analysis, an independent Data and Safety Monitoring Board found no safety issues with the vaccine candidate and recommended that the study continue collecting efficacy data until the next analysis. Moderna stock was down 3.6% at market close Tuesday following the news. Developed using the company’s proprietary mRNA platform, mRNA-1010 is Moderna’s first flu vaccine candidate. It works by encoding for hemagglutinin glycoproteins found on four influenza strains, in line with WHO recommendations: A/H1N1, A/H3N2, influenza B/Yamagata lineage and influenza B/Victoria lineage. Moderna is currently running two Phase III trials in parallel to assess the safety and immunogenicity of mRNA-1010. The first, P301, is a randomized and observer-blinded study that enrolled more than 6,100 patients from the southern hemisphere, across sites in Argentina, Australia, Colombia, Panama and the Philippines. Preliminary data from P301, released in February, showed mRNA-1010 resulted in better seroconversion rates for A/H1N1 and A/H3N2 strains compared with a licensed seasonal flu vaccine. Against both influenza B strains, Moderna’s investigational shot was non-inferior to the approved vaccine. As for safety, mRNA-1010 was generally well-tolerated but led to a higher rate of solicited adverse reactions than the active comparator. Most side effects were mild. The second study, P302, is being conducted exclusively in the northern hemisphere. During Tuesday’s data drop, Moderna posted immunogenicity data showing that mRNA-1010 elicited geometric mean titer ratios indicative of better protection against both influenza A strains. It was non-inferior against both influenza B strains. P302 had no pre-specified success criteria for immunogenicity. An updated version of mRNA-1010, which is expected to be stronger against influenza B strains, will enter a confirmatory Phase III study later this month, Moderna announced. Moderna’s flu vaccine pipeline also includes mRNA-1011 and mRNA-1012, penta- and hexavalent candidates that encode for more hemagglutinin candidates to target more influenza strains. The company is also developing mRNA-1020 and mRNA-1030, both of which express neuraminidase antigens to prime the immune system against more conserved regions of the flu virus. Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com

Phase 3VaccinemRNAClinical ResultImmunotherapy

09 Aug 2021

·www.biospace.com

Opthea Expands Global Phase 3 ShORe and COAST Wet AMD Trials of OPT-302 into Canada

MELBOURNE, Australia, Aug. 09, 2021 (GLOBE NEWSWIRE) -- Opthea Limited (ASX:OPT; Nasdaq:OPT), a clinical stage biopharmaceutical company developing novel therapies to treat highly prevalent and progressive retinal diseases, announced today that recruitment is open to patients in Canada for the Phase 3 pivotal clinical program of OPT-302 for the treatment of wet (neovascular) age-related macular degeneration (AMD). Following formal authorization from the regulatory agency Health Canada, patient enrollment in the two concurrent Phase 3 registrational clinical trials, ShORe ( S tudy of O PT-302 in combination with R anibizumab) and COAST ( C ombination O PT-302 with A flibercept St udy) can now begin in Canada. The goal of the two studies is to evaluate the benefits of the Company’s VEGF-C/D ‘trap’ inhibitor, OPT-302, for wet AMD in treatment-naïve patients. To date, the Phase 3 pivotal clinical program has begun in the United States, and the latest expansion into Canada represents a new and important geographical region. The Company is also advancing towards approval from national regulatory agencies and ethics committees from other countries, including those in the European, South American, and Asia Pacific regions, to finalize the implementation of the Phase 3 studies in those geographic areas. “Expanding our global reach for the Phase 3 pivotal program is an important milestone for Opthea, and this is the first time clinical trials have been conducted in Canada to investigate OPT-302 in patients with retinal disease,” commented Dr Megan Baldwin, CEO and Managing Director of Opthea. “We believe that OPT-302, if successful in Phase 3 and approved, has the potential to improve the trajectory of wet AMD disease progression. Therefore, we are working with regulatory authorities worldwide to initiate the Phase 3 registrational clinical trials as quickly as possible in other countries.” The U.S. Food and Drug Administration (FDA) recently awarded OPT-302 Fast Track status based on positive safety and efficacy results from Opthea’s previous Phase 1/2 and Phase 2b clinical studies in wet AMD. This designation helps to speed clinical development, regulatory review, and market entry upon approval of treatments with a potential to address serious conditions. In the two pivotal Phase 3 clinical trials, treatment naïve wet AMD patients will be randomized to receive intravitreal administration of 2 mg OPT-302 once every 4 weeks or 8 weeks in combination with 0.5 ranibizumab (ShORe) or 2 mg aflibercept (COAST) compared to the respective sham (control) combination treatment, during the first 52 weeks, at which time the primary efficacy analysis of the mean change in Best Corrected Visual Acuity (BCVA) from baseline will be performed. The top-line 52-week data from the ShORe and COAST Phase 3 studies is anticipated in 2H CY 2023 and if positive, the Company plans to file for global marketing authorizations for OPT-302 as a treatment for wet AMD following receipt of that data. The initiation of the Phase 3 pivotal clinical program follows the positive outcomes from the Phase 2b clinical trial of OPT-302 in 366 patients with wet AMD, which demonstrated that OPT-302, in combination with standard of care anti-VEGF-A therapy, ranibizumab (Lucentis), had a statistically significant superior mean gain in best-corrected visual acuity over ranibizumab monotherapy at week 24. The ShORe and COAST Phase 3 trials build upon and maintain key features of the successful Phase 2b wet AMD clinical trial, whilst also evaluating the administration of OPT-302 combination therapy over a longer treatment period and in a greater number of patients. Additional information on Opthea’s technology and the Phase 3 pivotal clinical trials can be found at and at (ShORe trial, ID#: NCT04757610; COAST trial, ID#: NCT04757636). About Opthea Opthea (ASX:OPT; Nasdaq:OPT) is a biopharmaceutical company developing novel therapies to address the unmet need in the treatment of highly prevalent and progressive retinal diseases, including wet age-related macular degeneration (wet AMD) and diabetic macular edema (DME). Opthea’s lead product candidate OPT-302 is in pivotal Phase 3 clinical trials and being developed for use in combination with anti-VEGF-A monotherapies to achieve broader inhibition of the VEGF family, with the goal of improving overall efficacy and demonstrating superior vision gains over that which can be achieved by inhibiting VEGF-A alone. Inherent risks of Investment in Biotechnology Companies There are a number of inherent risks associated with the development of pharmaceutical products to a marketable stage. The lengthy clinical trial process is designed to assess the safety and efficacy of a drug prior to commercialization and a significant proportion of drugs fail one or both of these criteria. Other risks include uncertainty of patent protection and proprietary rights, whether patent applications and issued patents will offer adequate protection to enable product development, the obtaining of necessary drug regulatory authority approvals and difficulties caused by the rapid advancements in technology. Companies such as Opthea are dependent on the success of their research and development projects and on the ability to attract funding to support these activities. Investment in research and development projects cannot be assessed on the same fundamentals as trading and manufacturing enterprises. Therefore, investment in companies specializing in drug development must be regarded as highly speculative. Opthea strongly recommends that professional investment advice be sought prior to such investments. Forward-looking statements Certain statements in this announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statement describing Company goals, expectations, intentions or beliefs is a forward-looking statement and should be considered an at risk statement, including, but not limited to, the continuation of patient recruitment for Opthea’s pivotal Phase 3 clinical trials of OPT-302 in wet AMD. Such statements are based on Opthea’s current plans, objectives, estimates, expectations and intentions and are subject to certain risks and uncertainties, including risks and uncertainties associated with clinical trials and product development and the impact of general economic, industry or political conditions in Australia, the United States or internationally. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus filed with the SEC on October 19, 2020. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise, except as required under applicable law. You should not place undue reliance on these forward-looking statements as predictions of future events, which statements apply only as of the date of this announcement. Actual results could differ materially from those discussed in this ASX announcement. Authorized for release to ASX by Megan Baldwin, CEO & Managing Director

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100 Deals associated with YH-14617

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Indication	Highest Phase	Country/Location	Organization	Date
Parkinson Disease	Phase 2	KR	Peptron Ltd.	30 Jan 2022
Dyskinesias	Preclinical	KR	Peptron Ltd.	30 Jan 2022
Young onset Parkinson disease	Discovery	KR	Peptron, Inc.	19 Mar 2020
Diabetes Mellitus, Type 2	Discovery	KR	Yuhan Corp.	01 Dec 2011
Diabetes Mellitus, Type 2	Discovery	KR	Peptron, Inc.	01 Dec 2011

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ADA2021	Not Applicable	-	-	SR-Exenatide	(kiojymjtha) = wbjsiynthg vnprveqemf (etyhlbgrpj ) View more	-	01 Jun 2021