A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Tolerability of Pulsed GRF6019 Infusions in Subjects With Severe Alzheimer's Disease

This study will evaluate the safety, tolerability, and potential cognitive benefit of the experimental treatment GRF6019 in subjects with severe Alzheimer's disease.

Start Date15 Jan 2019

Sponsor / Collaborator

Alkahest, Inc.

NCT03520998

/ CompletedPhase 2

A Prospective, Randomized, Double-Blind, Dose-Comparison Concurrent Control Study to Assess the Safety and Tolerability of GRF6019 Infusions in Subjects With Mild to Moderate Alzheimer's Disease

This study is evaluating the safety, tolerability, and feasibility of GRF6019, a plasma-derived product, administered as an intravenous (IV) infusion, to subjects with mild to moderate Alzheimer's disease.

Start Date16 Apr 2018

Sponsor / Collaborator

Alkahest, Inc.

100 Clinical Results associated with GRF-6019

100 Translational Medicine associated with GRF-6019

100 Patents (Medical) associated with GRF-6019

Literatures (Medical) associated with GRF-6019

15 Jun 2021·Journal of Alzheimer's disease : JADQ3 · MEDICINE

Safety and Tolerability of GRF6019 Infusions in Severe Alzheimer’s Disease: A Phase II Double-Blind Placebo-Controlled Trial

Q3 · MEDICINE

Article

Author: Kay, Gary ; Koborsi, Katie ; Nikolich, Karoly ; Chao, Whitney ; Cummings, Jeffrey L. ; Klutzaritz, Vicki ; Scott, James ; Patel, Ashok K. ; Thein, Stephen G. ; Duclos, Tiffanie ; Beck, Brian ; Albensi, Benedict ; Hannestad, Jonas ; Braithwaite, Steven

Background: The plasma fraction GRF6019 shows multiple benefits on brain aging in mice, including enhanced cognition, neurogenesis, and synaptic density, as well as reduced neuroinflammation. Objective: To evaluate the safety, tolerability, and preliminary efficacy of GRF6019 in patients with severe Alzheimer’s disease (AD). Methods: A phase II, double-blind, placebo-controlled study in patients with severe AD (Mini-Mental State Examination score 0–10). Patients were randomized 2 : 1 to GRF6019 (N = 18) or placebo (N = 8) and received daily 250 mL intravenous infusions over 5 days. The primary endpoints were the rates of adverse events (AEs) and the tolerability of GRF6019 as assessed by the number of patients completing the study. Change from baseline in cognitive and functional assessments was also evaluated. Results: All patients completed 100%of study visits and infusions. The rate of AEs was similar in the GRF6019 (8/18 patients [44.4%]) and placebo (3/8 patients [37.5%]) groups, and there were no deaths or serious AEs. The most common AEs considered related to treatment were mild, transient changes in blood pressure in the GRF6019 group (hypotension: 2 patients [11.1%]; hypertension: 1 patient [5.6%]); there were no related AEs in the placebo group. The trial was not powered to detect statistically significant differences between treatment groups. At the end of the study, patients in both treatment groups remained stable or improved on all cognitive and functional endpoints. Conclusion: GRF6019 demonstrated excellent safety, feasibility, and tolerability. Future trials designed to characterize the potential functional benefits of GRF6019 and related plasma fractions in severe AD are warranted.

01 Jan 2020·Alzheimer's & dementia (New York, N. Y.)

Safety and tolerability of GRF6019 in mild‐to‐moderate Alzheimer's disease dementia

Article

Author: Lohr, Scott ; Páez, Antonio ; Ray, Rebecca ; Cummings, Jeffrey L. ; Nikolich, Karoly ; Klutzaritz, Vicki ; Hannestad, Jonas ; Chao, Whitney ; Kay, Gary ; Braithwaite, Steven ; Jackson, Sam ; Koborsi, Katie

Abstract:

Introduction:

This phase 2 trial evaluated the safety, tolerability, and feasibility of repeated infusions of the plasma fraction GRF6019 in mild‐to‐moderate Alzheimer's disease.

Methods:

In this randomized, double‐blind, dose‐comparison trial, 47 patients were randomized 1:1 to receive daily infusions of 100 mL (n = 24) or 250 mL (n = 23) of GRF6019 for 5 consecutive days over two dosing periods separated by a treatment‐free interval of 3 months.

Results:

The mean (standard deviation [SD]) age of the enrolled patients was 74.3 (6.9), and 62% were women. Most adverse events (55%) were mild, with no clinically significant differences in safety or tolerability between the two dose levels. The mean (SD) baseline Mini‐Mental State Examination score was 20.6 (3.7) in the 100 mL group and 19.6 (3.7) in the 250 mL group; at 24 weeks, the within‐patient mean change from baseline was –1.0 points (95% confidence interval [CI], –3.1 to 1.1) in the 100 mL group and +1.5 points (95% CI, –0.4 to 3.3) in the 250 mL group. The within‐patient mean change from baseline on the Alzheimer's Disease Assessment Scale‐Cognitive subscale was –0.4 points (95% CI, –2.9 to 2.2) in the 100 mL group, while in the 250 mL group it was –0.9 points (95% CI, –3.0 to 1.2). The within‐patient mean change from baseline on the Alzheimer's Disease Cooperative Study‐Activities of Daily Living was –0.7 points in the 100 mL group (95% CI, –4.3 to 3.0) and –1.3 points (95% CI, –3.4 to 0.7) in the 250 mL group. The mean change from baseline on the Category Fluency Test, Clinical Dementia Rating Scale–Sum of Boxes, Alzheimer's Disease Cooperative Study–Clinical Global Impression of Change, and Neuropsychiatric Inventory Questionnaire was similar for both treatment groups and did not show any worsening.

Discussion:

GRF6019 was safe and well tolerated, and patients experienced no cognitive decline and minimal functional decline. These results support further development of GRF6019.

News (Medical) associated with GRF-6019

03 Feb 2021

·www.biospace.com

Clinical Catch-Up: January 25-29

It was a busy week for clinical trial news. Read on for more information. COVID-19-Related Johnson & Johnson announced topline efficacy and safety data from the Phase III ENSEMBLE trial of its single-dose COVID-19 vaccine in development by Janssen Pharmaceutical Companies. It met all primary and key secondary endpoints. The data suggested the vaccine was 66% effective overall in preventing moderate to severe COVID-19, 28 days after vaccination, with protection observed as early as day 14. There were variations in country-to-country studies against moderate to severe COVID-19 infection 28 days after vaccination: U.S. (72%); Latin America (66%); South Africa (57%). Against severe disease, it was 85% effective in all regions 28 days after vaccination, with efficacy increasing over time with no cases reported after day 49. It demonstrated complete protection against COVID-19-related hospitalization and death, 28 days after vaccination. Merck announced that it was going to stop developing its two COVID-19 vaccine candidates, dubbed V590 and V591, after poor responses in the Phase I trials. They are shifting their attention to advancing two therapeutic drugs for COVID-19, MK-4482 and MK-7110. Merck is developing MK-4482 with Ridgeback Biotherapeutics. In the Phase I trials, V590 and V591 were generally well tolerated, but the company reports that immune responses were inferior to what was observed in people who recovered naturally from COVID-19 infections. Eli Lilly and Company announced the results of its Phase III BLAZE-2 COVID-19 prevention trial, conducted with the U.S. National Institute of Allergy and Infectious Diseases (NIAID) and the COVID-19 Prevention Network (CoVPN). The trial evaluated the company’s bamlanivimab (LY-COV555), its neutralizing antibody, in COVID-19 in residents and staff at nursing homes in the U.S. At eight weeks of follow-up, there was a significantly lower frequency of symptomatic COVID-19 in the bamlanivimab treatment arm compared to placebo. Eli Lilly’s bamlanivimab and esesivimab together significantly decreased COVID-19-related hospitalizations, hitting the primary endpoint of the Phase III BLAZE-1 trial. Bamlanivimab is a recombinant, neutralizing human IgG1 monoclonal antibody directed against the COVID-19 virus spike protein. Etesevimabis a recombinant fully human monoclonal neutralizing antibody that specifically binds to the SARS-CoV-2 surface spike protein receptor binding domain with high affinity and can block the binding of the virus to the ACE2 host cell surface receptor. Achiko AG and Regenacellx.sl announced the completion of their Phase I trial of its nanoparticulate DNA aptamer conjugate and diagnostic testing technology, Project Gumnuts. The COVID-19 testing study demonstrated in field tests 80% sensitivity and 63% specificity. Applying software and machine learning increased it to 91% sensitivity and 85% specificity. Regeneron Pharmaceuticals announced positive initial data from its ongoing Phase III trial of its antibody cocktail, REGEN-COV, as a passive vaccine to prevent COVID-19 in people at high risk of infection from household exposure. The trial is being run with NIAID. Exploratory analysis found that the cocktail demonstrated 100% prevention of symptomatic infection in the 400 patients that could be evaluated. There was also about a 50% lower overall rate of infection, symptomatic and asymptomatic. The lower number of infections in the group on the cocktail were all asymptomatic, with decreased peak virus levels and a short duration of viral shedding, suggesting they were less likely to spread the disease. Vir Biotechnology, Eli Lilly and GlaxoSmithKline inked a three-way deal to evaluate Vir’s monoclonal antibody, VIR-7831, in combination with Lilly’s bamlanivimab in low-risk mild to moderate COVID-19 patients. Lilly expanded its ongoing BLAZE-4 study to include Vir’s compound. Vir and GSK were already partnered on the development of VIR-7831. Dr. Reddy's Laboratories and Global Response Aid FZCO terminated its Avigan Trial Study in Kuwait focused on moderate to severe COVID-19 patients in a hospital setting. The Phase III study in outpatient setting in North America in partnership with Appili Therapeutics and Global Response Aid will continue. The Kuwait study did not show a statistically significant difference for the primary endpoint for Avigan compared to placebo. Avigan (favipiravir) is an antiviral drug marketed by Fujifilm Toyota Chemical Co. Valneva completed enrollment in its Phase I/II trial of its COVID-19 vaccine candidate. VLA2001 is an inactivated vaccine candidate, meaning it uses an inactivated SARS-CoV-2 virus with an adjuvant to further stimulate the immune system. Initial data is expected in April. EmitBio announced that its clinical trial of EmitBIo device achieved a 99.9% reduction in average viral load of SARS-CoV-2 and accelerated time to symptom resolution by more than 48 hours compared to the control group. The device uses a small handheld device that directs precise wavelengths of safe, visible, targeted light to the back of the throat and surrounding tissues. Novavax reported that NVX-CoV2373, its COVID-19 vaccine, demonstrated an efficacy of 89.3% in its Phase III trial in the UK. It also announced positive data from its Phase IIb trial in South Africa. Non-COVID-19-Related Roche announced topline data from two identical Phase III trials, TENAYA and LUCERNE, of faricimab in neovascular or “wet” age-related macular degeneration (nAMD). Both trials hit their primary endpoint, demonstrating visual acuity outcomes that were non-inferior to aflibercept injections. They received faricimab injections at fixed intervals up to every 16 weeks compared to every eight weeks for aflibercept. Aflibercept is marketed by Regeneron Pharmaceuticals as Eylea. Faricimab is a bispecific antibody, meaning it is designed to recognize two different antigens. In this case, it targets angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A), both of which are associated with several diseases of the retina. Abeona Therapeutics announced it held a successful Type B meeting with the FDA over its co-primary endpoints for the pivotal Phase III VIITAL trial of EB-101 in recessive dystrophic epidermolysis bullosa (RDEB). The drug is an autologous, gene-corrected cell therapy. RDEB is a rare connective tissue disorder with no approved therapies. Vir Biotechnology announced initial topline data from its ongoing Phase I trial of VIR-3434 in chronic hepatitis B virus (HBV) infection. The early data demonstrated a mean reduction in serum hepatitis B virus surface antigen by day eight. VIRI-3434 is an HBV-neutralizing monoclonal antibody designed to block entry of all 10 genotypes of HBV into hepatocytes and decrease the level of viral and subviral particles in the blood. Rhythm Pharmaceuticals announced positive proof-of-concept data from multiple cohorts in its Phase II Basket Study of setmelanotide in patients with severe obesity due to genetic variants in the melanocortin-4 receptor (MC4R) pathway. Setmelanotide (Imcivree) is indicated for chronic weight management in adults and children age six years and older with obesity due to proopiomelanocortin (POMC), proprotein convertase subtilism/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency. Exilixis initiated the first-in-human Phase I trial of XL1-2 alone or in combination with other therapies in patients with inoperable locally advanced or metastatic solid tumors. XL102 is a potent, selective and orally bioavailable inhibitor of cyclin-dependent kinase 7 (CDK7). Pfizer announced co-primary endpoint data from a recently wrapped post-market safety study of tofacitinib at two doses compared to a TNF inhibitor in patients with rheumatoid arthritis who were 50 years of age or older with at least one additional cardiovascular risk factor. The co-primary endpoints were non-inferiority of tofacitinib compared to TNFi in relation to major adverse cardiovascular events (MACE) and malignancies (excluding non-melanoma skin cancer (NMSC). The non-inferiority criteria were not met for the endpoints, with no evidence of a difference between the two tofacitinib treatment groups. Agios Pharmaceuticals reported its Phase III ACTIVATE-T trial of mitapivat in regularly transfused adults with PK deficiency demonstrated a statistically significant and clinically meaningful decrease in transfusion burden. Mitapivat is a first-in-class oral, small molecule allosteric activator of wild-type and a variety of mutated PKR enzymes. NervGen Pharma Corp announced it was adding an Alzheimer’s disease patient cohort to its Phase I trial of NVG-291. The Phase I program was originally going to be in healthy volunteers. The drug is a specific and selective protein tyrosine phosphatase sigma inhibitor. EyePoint Pharmaceuticals dosed the first patient in its Phase I trial of EYP-1901 as a potential twice-yearly sustained delivery anti-VEGF treatment for wet age-related macular degeneration (wet AMD). The drug uses the company’s Durasert drug delivery technology that is already approved in four FDA-approved products. Organicell Regenerative Medicine announced the FDA had approved its IND for Zofin in COPD. The approved Phase I/II clinical trial will evaluate the safety and efficacy of IV Zofin for COPD. Zofin is an acellular, biologic derived from perinatal sources and is engineered to retain naturally occurring microRNAs. Takeda Pharmaceutical announced new data from the Phase I/II trial of TAK-788 (mobocertinib) in previously treated patients with EGFR Exon20 insertion+ metastatic non-small cell lung cancer (mNSCLC). The data showed the drug resulted in clinically meaningful responses and a “noteworthy” duration of response in this patient population. Mobocertinib is an oral tyrosine kinase inhibitor (TKI) designed to target EGFR Exon20 insertion mutations. Alklahest published data from its Phase II trial of GRF6019 for Alzheimer’s disease. It met the primary endpoint, showing both dose levels were safe and well tolerated. Patients also demonstrated a lack of cognitive decline and limited functional decline over the 24-week study period. The drug is a proprietary plasma fraction that has enhanced neurogenesis and improved age-related deficient in learning and memory, as well as decreased neuroinflammation in preclinical animal studies. Orion Biotechnology Canada presented results from their Phase I trial of OB-002H at the HIVR4P virtual meeting. It evaluated OB-002h Gel for prevention of HIV. OB-002 is a CCR5 inhibitor with best-in-class in vitro potency and is also being studied in oncology and COVID-19. Amgen announced results from the Phase II cohort of the CodeBreaK 100 trial of sotorasib in 126 patients with KRAS G12C-mutated advanced non-small cell lung cancer (NSCLC). The drug demonstrated a confirmed objective response rate (ORR) and disease control rate (DCR) of 37.1% and 80.6%, respectively, and a median duration of response of 10 months. Sotorasib is an investigational KRASG12C inhibitor. Janssen Pharmaceutical Companies, of J&J, announced new data from the Phase I CHRYSALIS trial of amivantamab in metastatic or unresectable non-small cell lung cancer (NSCLC) and EGFR exon 20 insertion mutations whose disease progressed on or after platinum-based chemotherapy. The drug is an investigational, fully-human EGFR and MET bispecific antibody. The findings demonstrated robust activity and durable responses. Most Read Today

VaccineAntibodyFirst in ClassCell TherapySmall molecular drug

28 Jan 2021

·www.biospace.com

Alkahest Announces Peer-Reviewed Publication Demonstrating Safety and Tolerability of GRF6019 in Patients with Mild-to-Moderate Alzheimer’s Disease

GRF6019 was safe and well-tolerated, and patients experienced no cognitive decline and minimal functional decline SAN CARLOS, Calif., Jan. 28, 2021 (GLOBE NEWSWIRE) -- Alkahest, Inc., a clinical stage biotechnology company focused on discovering and developing transformative therapies to treat age-related diseases and a subsidiary of Grifols, today announced the publication of a peer-reviewed article in the journal Alzheimer’s & Dementia: Translational Research & Clinical Interventions. The publication titled, “Safety and tolerability of GRF6019 in mild-to-moderate Alzheimer’s disease dementia,” describes Alkahest’s Phase 2 clinical trial investigating GRF6019 as a potential treatment for patients with Alzheimer’s disease (AD) and is available online here. “With a rapidly growing elderly population, the rates of chronic age-related diseases are on track to skyrocket in the coming years,” said Karoly Nikolich, chief executive officer and co-founder of Alkahest. “The publication of GRF6019’s safety and tolerability data in Alzheimer’s and Dementia reflects the potential of Alkahest’s novel approach to tackle Alzheimer’s disease, an indication that has seen little meaningful clinical progress in the past few decades. We look forward to further studying its potential as a more effective therapeutic option for this drastically underserved patient population.” Study highlights: The trial met its primary endpoint, demonstrating that both dose levels were safe and well tolerated, with no clear difference in adverse events between the 100 and the 250 milliliter dose arms. Patients treated with GRF6019 showed a lack of cognitive decline and limited functional decline over the 24-week study period. Alkahest is studying GRF6019 as a potential treatment for age-related diseases in collaboration with clinical development partner and parent company, Grifols. GRF6019 is a proprietary plasma fraction that has enhanced neurogenesis, improved age-related deficits in learning and memory and reduced neuroinflammation in preclinical animal models. Having completed human studies with GRF6019 in patients with both mild-to-moderate and severe Alzheimer’s disease, Alkahest plans to advance GRF6019 to further study its efficacy in these patient populations. About ALK6019-201 The Phase 2a ALK6019-201 trial was designed to evaluate the safety, tolerability, and potential therapeutic effects of two doses of GRF6019 in patients with mild-to-moderate Alzheimer’s disease over six months. Subjects were randomized to receive either 100 mL or 250 mL of GRF6019 given by intravenous administration daily for five consecutive days during week 1 and again for five consecutive days during week 13, with a treatment-free interval of 11 weeks following each dose. About Grifols Grifols is a global healthcare company that since its founding in Barcelona in 1909 has enhanced the health and well-being of people around the world. Its four divisions – Bioscience, Diagnostic, Hospital and Bio Supplies – develop, produce and market innovative solutions and services in more than 100 countries. As pioneers in the plasma industry, Grifols is one of the largest plasma companies, with a growing network of donation centers worldwide. It develops this plasma into essential medicines used to treat chronic, rare and, at times, life-threatening conditions. As a recognized leader in transfusion medicine, Grifols also offers a comprehensive portfolio of solutions designed to enhance safety from donation through transfusion. And the company supplies tools, information and services that enable hospitals, pharmacies and healthcare professionals to efficiently deliver expert medical care. Grifols, with more than 24,000 employees in 30 countries and regions, is committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry. In 2019, Grifols’ economic impact in its core countries of operation was 8.5 billion euros. The company also generated 148,000 jobs, including indirect and induced. The company’s class A shares are listed on the Spanish Stock Exchange, where they are part of the Ibex-35 (MCE:GRF). Grifols non-voting class B shares are listed on the Mercado Continuo (MCE:GRF.P) and on the U.S. NASDAQ through ADRs (NASDAQ:GRFS). Alkahest is a clinical stage biopharmaceutical company dedicated to discovering and developing treatments for neurodegenerative and age-related diseases with transformative therapies targeting the aging plasma proteome. The Alkahest pipeline includes multiple therapeutic candidates ranging from selected plasma fractions to protein-targeted interventions which aim to slow the detrimental biological processes of aging. For more information, please visit or . Media Contact Michael Tattory LifeSci Communications 1 (646) 751-4362 mtattory@lifescicomms.com

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17 Dec 2019

·www.biospace.com

Aging in Waves: New Findings on Aging-Related Proteins in the Blood

In an effort to understand aging, researchers from Stanford University and colleagues around the world analyzed almost 3,000 proteins in the blood of more than 4,000 people ages 18 to 94. In an effort to understand aging, researchers from Stanford University and colleagues around the world analyzed almost 3,000 proteins in the blood of more than 4,000 people ages 18 to 94. They published their research in the journal Nature Medicine . “When we went into this, we assumed you aged gradually, so we would see these changes taking place relatively steadily as individuals get older,” said Tony Wyss-Coray, professor of neurology at Stanford University, senior author of the study. That isn’t what they found, however. They found that the proteins appear to change in three distinct waves, with the first occurring during our 30s, peaking around age 34. “Then we found a second wave around 60, and then we found a third one, the most prominent one, really around 80 years of age,” Wyss-Coray said. The researchers are dubbing this a “proteomic clock,” that somewhat accurately predicts an individual’s age. One of the reasons for the research was the insight that by placing the blood of younger mice into older mice, the older mice appeared to grow younger—the reverse happened, too—the blood from older mice aged younger mice. So, what’s in the blood of different-aged animals (including people) that is making these changes for better or worse? Another fact Wyss-Coray and his team knew was that in the blood proteins of people with Alzheimer’s disease, the biggest differences weren’t between Alzheimer’s patients and healthy people of the same age, but between people of different ages. The researchers winnowed the thousands of proteins they were looking at down to 373 whose levels appeared to be predictive of age. hbspt.cta.load(4413123, '4e87abe9-779b-4c65-98dd-ea451779faa9', {}); Wyss-Coray notes that most of the proteins found in the blood derive from other tissues. “So we can start to ask where … these proteins come from and if they change with age.” For example, proteins that trace back to the liver would suggest the liver is aging. Or if they derive from the kidney, the kidney is aging. Wyss-Coray hopes to eventually be able to analyze blood protein patterns to create a personalized aging clock “where I can tell you, based on the composition of your blood, your kidney seems to be aging faster than it should.” And perhaps, if enough information is found, similar to the mouse aging experiments, it might be possible to isolate proteins that contribute to the effect—preferably the one that keeps you young, not makes you old. Some companies went into the business of selling blood transfusion plasma from young people as an anti-aging potion. The U.S. Food and Drug Administration (FDA), in February 2019, issued warnings to consumers and health care providers against this, pointing out that the FDA did not test these in order to confirm therapeutic benefit or safety. “We strongly discourage consumers from pursuing this therapy outside of clinical trials under appropriate institutional review board and regulatory oversight,” the agency said in a statement from then-Commissioner Scott Gottlieb. Gottlieb added, “Our concerns regarding treatments using plasma from young donors are heightened by the fact that there is no compelling clinical evidence on its efficacy, nor is there information on appropriate dosing for treatment of the conditions for which these products are being advertised. Plasma is not FDA-recognized or approved to treat conditions such as normal aging or memory loss, or other diseases like Alzheimer’s or Parkinson’s disease.” The agency warned of possible risks of infectious, allergic, respiratory and cardiovascular problems from the treatments. Meanwhile, groups like Wyss-Coray’s and others are attempting to identify which proteins are most effective and whether the proteins themselves are active in staying young or just markers of something else. Irina Conboy, a researcher at the University of California, Berkeley, published research in the journal Aging in August 2019, that analyzed a protein known as TGF-beta, which is associated with aging. Her experiments in laboratory mice hint that by blocking TGF-beta, aging effects can be slowed. Wyss-Coray has founded a biotech company, Alkahest, that is researching blood plasma infusions in Alzheimer’s disease, as well as other applications of blood plasma infusions. At the recent 12 th Clinical Trials on Alzheimer’s Disease conference the company gave an oral presentation of Phase II trial of GRF6019 in mild-to-moderate Alzheimer’s disease. The Phase IIa trial was completed and patients were randomized and treated with 100mL or 250mL of GRF6019 for five days during Week 1 and again for five consecutive days until Week 13 with a treatment-free interval of 11 weeks after each dose. GRF6019 and another of its products, GRF6021, are proprietary plasma fractions developed and provided by Grifols. In animal models the plasma fractions improved neurogenesis as well as age-related learning and memory deficits. They also decreased neuroinflammation. Toshiko Tanaka, an investigator at the National Institute on Aging was the lead author of a study published in 2018 that leveraged similar techniques and also found proteins associated with aging. “One of the great things about these advancements,” she told NPR , is it’s becoming a lot cheaper to measure a lot of these molecules, so bigger studies and more studies can assess the same proteins.” At this time, the research is a way off from specifically identifying proteins associated with aging, but it’s a very good first step. Paola Sebastiani, a biostatistician at Boston University who has also conducted research on aging and blood proteins, told NPR that, “For a long time we have focused, in the field of healthy aging, on genetics.” However, we generally can’t modify genes—although gene therapies and genome editing techniques such as CRISPR are starting to do just that. Sebastiani points out that one of the interesting aspects of these blood proteins is they can be inhibited or blocked or modified using a variety of biochemical and small molecule process that theoretically be used to improve health and slow the aging process. hbspt.forms.create({ portalId: "4413123", formId: "a126e976-bca0-4c13-aa9b-02e8feb92096" });

Phase 2Clinical Result

100 Deals associated with GRF-6019

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Alzheimer Disease	Phase 2	United States	Alkahest, Inc.	16 Apr 2018

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03765762 (CTgov)	Phase 2	Alzheimer Disease	26	GRF6019 (GRF6019)	ylpdsqcsba = syvqerdquo sfviwadcpx (omljwpakie, nvokqwtupm - aggpsecyly) View more	-	27 Jan 2021
				Placebo (Placebo)	ylpdsqcsba = kyxprksmsd sfviwadcpx (omljwpakie, bnlkopmvfh - cfllkglehq) View more
NCT03520998 (Pubmed) Manual	Phase 2	Alzheimer Disease	47	GRF6019 (100 mL)	umqbuflwej(evjfmkmdrk) = irqlqshbdj reebxudljk (eommhpnket, -2.9 to 2.2) View more	Positive	16 Dec 2020
				GRF6019 (250 mL)	umqbuflwej(evjfmkmdrk) = hvocgddnyx reebxudljk (eommhpnket, -3.0 to 1.2) View more
NCT03520998 (CTgov)	Phase 2	Alzheimer Disease	47	GRF6019 (GRF6019 Low Dose)	ycmdkyxdyh = ffcwalojid xjbzsuehnd (wzpnjzxxdp, oyvdzbhkjo - kzwuuydpob) View more	-	05 Nov 2020
				GRF6019 (GRF6019 High Dose)	ycmdkyxdyh = taifpwyksn xjbzsuehnd (wzpnjzxxdp, gefvkibhro - oybszxgfrw) View more

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