A Phase 3 Study to Evaluate the Efficacy and Safety of 3K3A-APC in Combination with Tissue Plasminogen Activator, Mechanical Thrombectomy, or Both in Subjects with Moderate to Severe Acute Ischemic Stroke

The purpose of this study is to evaluate the efficacy and safety of intravenous doses of 3K3A-APC, a recombinant variant of human activated protein C (APC), in the treatment of acute ischemic stroke following treatment with thrombolysis, mechanical thrombectomy or both.

Start Date01 Oct 2024

Sponsor / Collaborator

ZZ Biotech LLC

[+4]

NCT05039268 / CompletedPhase 2IIT

A Phase 2 Open Label Trial of 3K3A-APC in Amyotrophic Lateral Sclerosis

Phase 2 open label trial to investigate the safety and potentially efficacy of 3K3A-APC in patients with Amyotrophic Lateral Sclerosis (ALS).

Start Date25 Nov 2021

Sponsor / Collaborator

Macquarie University

[+1]

NCT02222714 / CompletedPhase 2

A Multi-center, Phase 2 Study Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A-APC in Combination With tPA, Mechanical Thrombectomy or Both in Moderate to Severe Acute Ischemic Stroke

The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human activated protein C (APC), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.

Start Date01 Oct 2014

Sponsor / Collaborator

ZZ Biotech LLC

[+4]

100 Clinical Results associated with 3K3A-APC

100 Translational Medicine associated with 3K3A-APC

100 Patents (Medical) associated with 3K3A-APC

Literatures (Medical) associated with 3K3A-APC

01 Jan 2025·Journal of Trauma and Acute Care Surgery

Cytoprotective 3K3A-activated protein C and plasma: A comparison of therapeutics for the endotheliopathy of trauma

Article

Author: D'Alessandro, Angelo ; Stocker, Benjamin ; Gallagher, Lauren T ; Stafford, Preston ; Thielen, Otto ; Mosnier, Laurent ; Hallas, William ; Cohen, Mitchell ; Schaid, Terry ; Kelher, Marguerite ; Moore, Ernest ; Debot, Margot ; Silliman, Christopher C ; Mitra, Sanchayita ; Ramser, Benjamin ; Hansen, Kirk ; Griffin, John

BACKGROUND:

Both healthy plasma and cytoprotective aPC (3K3A-aPC) have been shown to mitigate the endotheliopathy of trauma (EoT), but optimal therapeutics remain unknown. Our aim was therefore to determine optimal therapies to mitigate EoT by investigating the effectiveness of 3K3A-aPC with and without plasma-based resuscitation strategies.

METHODS:

Electric cell-substrate impedance sensing (ECIS) was used to measure real-time permeability changes in endothelial cells. Cells were treated with a 2-μg/mL solution of aPC 30 minutes prior to stimulation with plasma taken from severely injured trauma patients (ISS > 15 and BD < −6) (TP). Healthy plasma, or plasma frozen within 24 hours (FP24), was added concomitantly with TP. Cells treated with thrombin and untreated cells were included in this study as control groups.

RESULTS:

A dose-dependent difference was found between the 5% and 10% plasma-treated groups when human umbilical vein endothelial cells were simultaneously stimulated with TP (μd, 7.346; 95% confidence interval [CI], 4.574–10.12). There was no difference when compared with TP alone in the 5% (μd, 5.713; 95% CI, −1.751 to 13.18) or 10% group (μd, −1.633; 95% CI, −9.097 to 5.832). When 3K3A-aPC was added to plasma and TP, the 5% group showed improvement in permeability compared with TP alone (μd, 10.11; 95% CI, 2.642 to 17.57), but there was no difference in the 10% group (μd −1.394; 95% CI, −8.859 to 6.070). The combination of 3K3A-aPC, plasma, and TP at both the 5% plasma (μd, −28.52; 95% CI, −34.72 to −22.32) and 10% plasma concentrations (μd, −40.02; 95% CI, −46.22 to −33.82) had higher intercellular permeability than the 3K3A-aPC preincubation group.

CONCLUSION:

Our data show that FP24, in a posttrauma environment, pretreatment with 3K3A-aPC can potentially mitigate the EoT to a greater degree than FP24 with or without 3K3A-aPC. Although further exploration is needed, this represents a potentially ideal and perhaps superior therapeutic treatment for the dysregulated thromboinflammation of injured patients.

01 Nov 2024·Journal of Stroke & Cerebrovascular Diseases

Effect of post thrombolytic intracerebral hemorrhage volume on 90-day outcomes in acute ischemic stroke patients

Article

Author: Fakih, Rami ; Huang, Yilun ; Bains, Navpreet K ; Qureshi, Adnan I ; French, Brandi R ; Lyden, Patrick D ; Siddiq, Farhan ; Gillani, Syed A ; Gomez, Camilo R ; Ma, Xiaoyu

BACKGROUND AND PURPOSE:

Post thrombolytic intracerebral hemorrhage (ICH) is associated with higher rate of death or disability in acute ischemic stroke patients. We investigated the relationship between post thrombolytic ICH volume and change in volume and death or disability at 90 days in acute ischemic stroke patients.

METHODS:

We analyzed 110 patents recruited in the Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY) trial who received intravenous tissue plasminogen activator (tPA) followed by mechanical thrombectomy (if indicated) and 3K3A-APC or placebo. ICH volume was measured at Day 2 and Day 7 using susceptibility weighted sequence (SWI) on magnetic resonance imaging (MRI). We also calculated the post thrombolytic ICH volume change between Day 2 and Day 7. Outcomes were determined by using utility weighted modified Rankin scale (UW-mRs) at 90-days, Outcomes were determined by using utility weighted modified Rankin scale (UW-mRS) at 90 days. To minimize interpretation bias, outcome assessors were blinded to the treatment allocation and clinical data.We adjusted for age, gender, National Institutes of Health Stroke Scale (NIHSS) score (<10,10-19 and ≥20), location of hemorrhage (single basal ganglia hemorrhage, single lobar, single cerebellum, and multiple sites) in multivariate regression analysis.

RESULTS:

A total of 88 (80%) of 110 patients had post thrombolytic ICH (mean volume 28.3 ml ± SD 62 ml). The strata of ICH volume were not associated with UW-mRs at 90 days: <20 cc (regression coefficient (RC)-0.05, p= 0.58), 20-39 cc (RC-0.22, p=0.17), or ≥40 cc (RC-0.34, p= 0.083) compared with no ICH after adjusting for potential confounders. Change in ICH mean volume 26.78 ml ±59.68, 52 had increase in volume) between Day 2 and day 7 was not associated with UW-mRS at 90 days (RC -67.71, p= 0.06).

CONCLUSIONS:

We did not observe any independent effect of post thrombolytic ICH volume on death or disability in acute ischemic stroke patients. Although further studies must be done, our data suggest that strategies to prevent ICH expansion such as antifibrinolytic medications and reduction in ICH volume such as surgical evacuation may not reduce death or disability in acute ischemic stroke patients with post thrombolytic ICH.

01 Feb 2024·Annals of neurology

Correction to Lyden P, Pryor KE, Coffey CS, et al. Final results of the RHAPSODY trial: a multi‐center, phase 2 trial using a continual reassessment method to determine the safety and tolerability of 3K3A‐APC, a recombinant variant of human activated protein C, in combination with tissue plasminogen activator, mechanical thrombectomy or both in moderate to severe acute ischemic stroke. Ann Neurol 2019;85:125–136.

News (Medical) associated with 3K3A-APC

15 Nov 2023

·www.biospace.com

ZZ Biotech Hit with Data Manipulation Allegations Regarding Stroke Trial

Pictured: Doctor looking at brain scan images/iStock, Tippapatt Phase II data supporting ZZ Biotech’s investigational stroke therapy 3K3A-APC might have been doctored to make the candidate appear safer and more effective than it actually is, according to an investigative report by the journal Science, citing a small group of whistleblowers. The whistleblowers produced a 113-page dossier—which has already been submitted to the National Institutes of Health (NIH)—detailing a potentially higher rate of deaths in patients that received the experimental treatment compared to placebo. Those who were given 3K3A-APC also showed worse disability and dependency toward the end of the mid-stage study. Besides the Phase II data, the dossier obtained by Science also alleges that preclinical data had been tampered with, including papers that supported the human testing for 3K3A-APC. Overall, the whistleblowers flagged a total of 35 papers with manipulated data plus two publications in connection with 3K3A-APC’s Phase II trial, according to Science. Underpinning these data manipulation allegations is a “culture of intimidation” at the lab of Berislav Zlokovic, co-founder of Houston-based ZZ Biotech and chairman of its scientific advisory board. According to the whistleblowers, Zlokovic allegedly routinely pressured his scientists to tweak the data in favor of 3K3A-APC. Zlokovic would allegedly tell his scientists to “change lab notebooks” after experiments so that they “only contained the desired results,” according to Science. The University of Southern California (USC), where Zlokovic works as a professor of physiology and neuroscience, said that it will conduct a confidential review of the dossier and investigate its merits. Zlokovic declined to comment to Science but his lawyer said in a statement that the professor knows some of the dossier’s contents “to be completely incorrect.” In acute ischemic stroke, 3K3A-APC’s development is being supported by the NIH’s National Institute of Neurological Disorders and Stroke, which has awarded USC a $30 million grant to conduct a Phase III trial. The first tranche of this grant, amounting to $4 million, was disbursed in May 2022. 3K3A-APC is a genetically engineered variant of the activated protein C (APC) molecule, which is a serine protease with known anticoagulant and cell-protective activity. This mechanism of action allows the candidate to reduce bleeding and inflammation in the brain following a stroke episode, as well as prevent cell death in the neurons, glia and other cells in the brain. In its Phase II RHAPSODY study, 3K3A-APC treatment led to a significant reduction in intracranial hemorrhage rates versus placebo, as well as a substantial, but not significant, reduction in the total hemorrhage volume. The mid-stage trial also documented an estimated toxicity rate of 7%. Beyond stroke, 3K3A-APC is currently in a Phase II study for amyotrophic lateral sclerosis and is about to enter mid-stage development for diabetic wound healing, according to ZZ Biotech’s website. 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 2Clinical Result

21 Feb 2023

·www.prnewswire.com

Amyotrophic Lateral Sclerosis Pipeline Booms as 100+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of amyotrophic lateral sclerosis has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of amyotrophic lateral sclerosis and the growing research and development activities to develop novel therapies to treat amyotrophic lateral sclerosis to drive the market. The companies developing the potential therapies in the last stage of development include Biogen, AB Sciences, Helixmith, and several others. LAS VEGAS, Feb. 21, 2023 /PRNewswire/ -- DelveInsight's ' Amyotrophic Lateral Sclerosis Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline amyotrophic lateral sclerosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the amyotrophic lateral sclerosis pipeline domain. Key Takeaways from the Amyotrophic Lateral Sclerosis Pipeline Report DelveInsight's amyotrophic lateral sclerosis pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for amyotrophic lateral sclerosis treatment. Key amyotrophic lateral sclerosis companies such as Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc. Woolsey Pharmaceuticals, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others are evaluating new amyotrophic lateral sclerosis drugs to improve the treatment landscape. Promising amyotrophic lateral sclerosis pipeline therapies in various stages of development include BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others. In February 2023, NeuroSense Therapeutics Ltd. and QuantalX Neuroscience Ltd; the developer of Delphi-MD, a clinically objective neurodiagnostic medical device , announced a collaboration to improve early diagnosis and treatment of neurodegenerative diseases.In addition, the companies agreed that QuantalX's Delphi-MD would be used for early diagnosis and ongoing monitoring of trial participants in NeuroSense's planned future pivotal Phase III efficacy trial of PrimeC in people living with amyotrophic lateral sclerosis (ALS), pending the successful conclusion of its ALS Phase IIb trial. In February 2023, Amylyx Pharmaceuticals, Inc. announced the completion of enrollment in PHOENIX, a global, 48-week, randomized, placebo-controlled Phase III clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) in people living with amyotrophic lateral sclerosis (ALS). Amylyx anticipates topline results in 2024. The study enrolled 664 participants living with ALS. In February 2023, UMass Chan Medical School signed a three-year sponsored research agreement with NeuShen Therapeutics Inc. to investigate a gene therapy treatment for amyotrophic lateral sclerosis, a rare neurological disease. Based in Shanghai and Boston, NeuShen is focused on developing innovative treatments for central nervous system disorders using adeno-associated virus-based gene therapy and small molecule delivery. In January 2023, Inflamed Pharma, part of the incubator and accelerator company Xlife Sciences, partnered with researchers at the University Medical Center Gottingen in Germany to develop its investigational therapy ProcCluster for the treatment of amyotrophic lateral sclerosis (ALS).The collaboration, led by Jan C. Koch, MD, a principal investigator at the university's Department of Neurology, will be focused particularly on investigating ProcCluster in cellular models of ALS. In January 2023, Amylyx Pharmaceuticals and Neopharm signed a license and distribution agreement to commercialize AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) to treat amyotrophic lateral sclerosis (ALS).Neopharm will commercialize the oral, fixed-dose medication in Israel, West Bank, Gaza, and the Palestinian Authority, subject to regulatory review and clearance.According to the agreement, Amylyx will grant exclusive rights to Neopharm for commercializing the therapy in the covered territory. In January 2023, uniQure N.V. and Apic Bio announced that they have entered into a global licensing agreement for APB-102 to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), a rare, genetic form of ALS. Under the agreement, uniQure acquires global rights for the development and commercialization of APB-102, adding to its pipeline of gene therapies to treat neurological disorders. Request a sample and discover the recent advances in amyotrophic lateral sclerosis drug treatment @ Amyotrophic Lateral Sclerosis Pipeline Report The amyotrophic lateral sclerosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage amyotrophic lateral sclerosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the amyotrophic lateral sclerosis clinical trial landscape. Amyotrophic Lateral Sclerosis Overview Amyotrophic Lateral Sclerosis (ALS) is a rare neurological disease that affects the nerve cells (neurons) that control voluntary muscle movement (those muscles we choose to move). Voluntary muscles are responsible for movements such as chewing, walking, and talking. The disease is progressive, which means that the symptoms worsen over time. There is currently no cure for ALS and no effective treatment to slow or reverse the disease's progression. Muscle weakness or stiffness are common early ALS symptoms. Individuals gradually lose strength and the ability to speak, eat, move, and even breathe as all voluntary muscles are affected. Most people with ALS die from respiratory failure, usually within 3 to 5 years of the onset of symptoms. However, approximately 10% of people with ALS live for ten years or more. There is no single test that can definitively diagnose ALS. A detailed history of the symptoms observed by a physician during physical examination, as well as a review of the individual's full medical history and a series of tests to rule out other diseases, are used to make the ALS diagnosis. Find out more about drugs for amyotrophic lateral sclerosis @ New Amyotrophic Lateral Sclerosis Drugs A snapshot of the Amyotrophic Lateral Sclerosis Pipeline Drugs mentioned in the report: Learn more about the emerging amyotrophic lateral sclerosis pipeline therapies @ Amyotrophic Lateral Sclerosis Clinical Trials Amyotrophic Lateral Sclerosis Therapeutics Assessment The amyotrophic lateral sclerosis pipeline report proffers an integral view of amyotrophic lateral sclerosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Amyotrophic Lateral Sclerosis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: RNA interference, Superoxide dismutase 1 expression inhibitors, Angiogenesis inhibitors, Colony stimulating factor inhibitors, Coronavirus-3C-like-proteinase inhibitors, Endopeptidase Clp inhibitors, Focal adhesion protein-tyrosine kinase inhibitors, Lyn protein-tyrosine kinase inhibitors, Macrophage colony-stimulating factor receptor modulators, Mast cell inhibitors, Platelet-derived growth factor receptor antagonists, Protein tyrosine kinase inhibitors, Proto oncogene protein c-kit inhibitors, Proto-oncogene protein c-fyn modulators, Type 3 fibroblast growth factor receptor antagonists, Angiogenesis inducing agents, Gene transference, Hepatocyte growth factor expression stimulants, G protein-coupled receptor modulators, HSP90 heat-shock protein modulators, Ion channel modulators, Antioxidants, NAD(P)H dehydrogenase (quinone) modulators, CD40 ligand inhibitors, Complement C1 inhibitors, Cyclo-oxygenase 2 inhibitors, DNA gyrase inhibitors Key Amyotrophic Lateral Sclerosis Companies: Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc. Woolsey Pharmaceuticals, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others. Key Amyotrophic Lateral Sclerosis Pipeline Therapies: BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others. Dive deep into rich insights for new drugs for amyotrophic lateral sclerosis treatment; visit @ Amyotrophic Lateral Sclerosis Medications Table of Contents For further information on the amyotrophic lateral sclerosis pipeline therapeutics, reach out @ Amyotrophic Lateral Sclerosis Drug Treatment Related Reports Amyotrophic Lateral Sclerosis Epidemiology Amyotrophic Lateral Sclerosis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted amyotrophic lateral sclerosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Amyotrophic Lateral Sclerosis Market Amyotrophic Lateral Sclerosis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key amyotrophic lateral sclerosis companies including Helixmith, Sanofi, Denali Therapeutics, Alector, GSK, NeuroSense Therapeutics, Biogen, among others. Duchenne Muscular Dystrophy Market Duchenne Muscular Dystrophy Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Duchenne muscular dystrophy companies including Edgewise Therapeutics, Pfizer, Daiichi Sankyo, among others. Nonsense Mutation Duchenne Muscular Dystrophy Pipeline Nonsense Mutation Duchenne Muscular Dystrophy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonsense mutation Duchenne muscular dystrophy companies, including Taiho Pharmaceutical, Solid Biosciences, Capricor, Nippon Shinyaku, among others. Becker Muscular Dystrophy Pipeline Becker Muscular Dystrophy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key becker muscular dystrophy companies, including Epirium Bio, Ultragenyx, Strykagen, among others. Facioscapulohumeral Muscular Dystrophy PIpeline Facioscapulohumeral Muscular Dystrophy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key facioscapulohumeral muscular dystrophy companies, including miRecule, Arrowhead Pharmaceuticals, Fulcrum Therapeutics, among others. 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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 Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3License out/inPhase 2

100 Deals associated with 3K3A-APC

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Ischemic stroke	Phase 3	-	ZZ Biotech LLC	01 Oct 2024
Ischemic stroke	Phase 3	-	University of Southern California	01 Oct 2024
Amyotrophic Lateral Sclerosis	Phase 2	AU	ZZ Biotech LLC	25 Nov 2021
Wound Infection	Phase 1	-	ZZ Biotech LLC	-

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05039268 (CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	16	3K3A-APC Protein (15mg Dose Group)	bcgjbwasfg(nxgzhvqkmr) = aqsyxwsvba ipahzassmb (dmttpwqgtt, ywgzbcxxxg - crlhicjzpj) View more	-	11 Oct 2023
				3K3A-APC Protein (30mg Dose Group)	bcgjbwasfg(nxgzhvqkmr) = mokkyhongu ipahzassmb (dmttpwqgtt, vanyfpmuwx - izbohcabhj) View more
NN104 (RHAPSODY) (ISC2020)	Not Applicable	Ischemic stroke	-	Placebo	kujrgcunwu(zjvyikabki) = zwgcjnxgqv ymmfhemzzs (ntcsawbifc ) View more	-	01 Feb 2020
				3K3A-APC	kujrgcunwu(zjvyikabki) = xhqiqmcvtq ymmfhemzzs (ntcsawbifc ) View more
NCT02222714 (RHAPSODY, Pubmed) Manual	Phase 2	Acute Ischemic Stroke	110	Tissue Plasminogen Activator+3K3A-APC	jxhajbqjti(gqltozxxvo) = ubkkyyfzae dmrmwkyrld (ivgbhbjhmk ) View more	Positive	01 Jan 2019
				Tissue Plasminogen Activator+Placebo	zhirogcewk(zgxbqwbigf) = wtnmfwjjmh pqnyqertxa (syvshwrfen, 5.8 )
NCT02222714 (RHAPSODY, CTgov)	Phase 2	Ischemic stroke	110	3K3A-APC (120 µg/kg of 3K3A-APC)	egsjopadac(cshfhfkuzu) = wkamgojsaw tqfjkdxwwt (bouwqtzjbg, kuwzttaiip - gezouukqpx) View more	-	08 Nov 2018
				3K3A-APC (240 µg/kg of 3K3A-APC)	egsjopadac(cshfhfkuzu) = xytghfyetk tqfjkdxwwt (bouwqtzjbg, gonidugtbk - rilfmxvxcj) View more

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