press releases
October 24, 2023
NeuroTherapia Presents Clinical Data from Phase 1b Clinical Trial of NTRX-07 for the Treatment of Alzheimer’s Disease
Overall positive safety profile supports advancement into Phase 2 clinical study Levels of NTRX-07 detected in the plasma correlate with levels expected to drive efficacy based on preclinical studies Measures of cognitive function suggest a trend toward improvement in Alzheimer’s disease patients treated with NTRX-07 CLEVELAND, OH., Oct. 24, 2023 - NeuroTherapia, Inc., a clinical-stage, privately held biotechnology company developing oral, small molecule drugs to address neuroinflammatory conditions of the central nervous system (CNS), today announced the presentation of clinical data from its Phase 1b clinical trial of NTRX-07, an oral, small molecule CB2-targeting therapy in development for the treatment of Alzheimer’s disease (AD), in healthy volunteers and a subset of patients with mild cognitive impairment or early AD, at the Clinical Trials on Alzheimer’s Disease (CTAD) conference, taking place in Boston, Mass., Oct. 24-27, 2023. Data from the study demonstrated a favorable safety profile at all dose ranges, a pharmacokinetic (PK) profile consistent with preclinical studies and in line with levels expected to drive clinical activity, and a trend toward cognitive improvement in the AD patients that were treated with NTRX-07. "We are very encouraged by the strong safety profile observed in this study and by the levels of NTRX-07 we observed in the plasma of the participants and patients in the study. The early signs of clinical activity we observed in the AD patients included in the study were even more encouraging. Of particular interest was the finding that NTRX-07 treatment partially reversed some of the qEEG changes, an accepted measure of cognitive function, that are associated with AD, " said Tony Giordano, Ph.D., President and CEO of NeuroTherapia. "We look forward to advancing NTRX-07 into a Phase 2 study where we can further evaluate clinical activity in patients in the hopes of bringing a novel therapy forward that has the potential to work synergistically with approved antibody treatments." Summary of study results: • 32 participants, including one cohort of 8 patients with early-stage AD, received NTRX-07 or a placebo for seven days in a double-blind, randomized clinical study. • The safety profile of NTRX-07 supports further clinical development, with no dose-limiting or serious adverse events observed during the trial. Across all dose levels (10mg, 30mg, or 90 mg), adverse events were mild and transient, and no participants discontinued treatment, with the exception of one who withdrew for personal reasons. • PK demonstrated that levels of NTRX-07 in the plasma were within the target ranges expected to drive efficacy based on the preclinical data. • Several cognitive function measures were evaluated within the cohort of AD patients. While the trial was not powered to detect a significant change in cognitive scores, an interesting trend toward improvement was observed in AD participants using the Alzheimer’s Disease Assessment Scale–cognitive subscale (ADAS-Cog) test. Of 6 treated patients tested with ADAS-Cog, all 6 showed a reduction in the number of errors following treatment, with 3 having clinically meaningful improvements (3-4 point score reduction). In contrast, neither of the non-treated AD patients showed an improvement. A post-hoc analysis was carried out on electroencephalogram (EEG) data collected for safety analysis, which showed that following treatment with NTRX-07, patients evaluated with quantitative electroencephalogram (qEEG) demonstrated a partial reversal of the lowering of mean frequency known to exist in AD patients. "There is an emerging consensus that neuroinflammation is a driver of CNS diseases, including AD. While most therapies have focused on removing amyloid, the AD community is beginning to recognize that combination treatments, including anti-inflammatory therapies, could be very beneficial,” said Joseph Foss, M.D., Chief Medical Officer of NeuroTherapia. "This data gives us additional confidence that NTRX-07 could become a valuable treatment option and based on its safety profile, could be used in combination with approved antibody treatments.” About NTRX-07 NTRX-07 is an orally available small molecule that targets a key receptor on activated microglia, specialized cells that play an important role in regulating immune system activity in the CNS. The drug reduces inflammation and improves the brain's ability to form new connections, leading to improved learning and memory. Inflammation in the brain is increasingly recognized as an important factor in many neurological diseases, and NTRX-07 provides a new approach for the treatment of these challenging conditions. NeuroTherapia is initially developing this product for the treatment of Alzheimer's disease. About NeuroTherapia NeuroTherapia is a clinical-stage, privately held biotechnology company developing oral, small-molecule drugs to address neuroinflammatory conditions of the central nervous system (CNS), including Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, and other CNS conditions. There is an emerging consensus that neuroinflammation plays a significant role in CNS disease. NeuroTherapia is developing therapeutics that inhibit microglia cells, which are known to express proteins that drive inflammation in the CNS, without affecting the clearance of toxic beta amyloid. We believe this approach will result in improved neuronal function and survival. At NeuroTherapia, our mission is to change the course of the most debilitating and deadly CNS diseases that patients and their families face today. For more information, please visit www.neurotherapia.com. Media Contact: Cory Tromblee, Scient PR cory@scientpr.com
December 1, 2020
NeuroTherapia Announces Completion of Phase 1a Clinical Trial
CLEVELAND, Dec. 1, 2020 /PRNewswire/ -- NeuroTherapia, Inc., a clinical-stage company focused on developing therapies for neurodegenerative diseases, announced today the completion of its first-in-human study of NTRX-07. This study was a single ascending dose clinical trial carried out in healthy volunteers. "The lack of dose-limiting toxicity gives us great confidence that this product will be safe for use in patients following longer-term administration," said Joseph Foss, M.D., the Company's Chief Medical Officer. "We were also enthusiastic about the blood levels of NTRX-07 achieved following dosing." Levels of NTRX-07 measured in the blood were 2-4 fold higher than those predicted from preclinical studies. Side effects were limited to lightheadedness and flushing in subjects in the two highest dosed cohorts. The side effects are likely evidence that that the drug is entering the central nervous system. The study was supported by an Alzheimer's Association Part the Cloud grant and was initially reported at the Alzheimer's Association International Conference in July 2020. "The completion of this study is an important first step in the development of NTRX-07," said Tony Giordano, Ph.D., the Company's President and CEO. "We anticipate initiating a 28-day study in subjects suffering from Alzheimer's Disease to understand the safety and pharmacokinetic profile of repeat doses in patients and will include an analysis of measures of inflammation before and after treatment to provide an early indication of bioactivity." NTRX-07 is an orally available small molecule that targets a key receptor on activated microglia, specialized cells that play an important role in the immune system of the brain. The drug reduces inflammation and improves the brain's ability to form new connections, leading to improved learning and memory. "Inflammation in the brain is increasingly recognized as an important factor in many neurological diseases, and NTRX-07 provides a new approach for the treatment of these challenging conditions," said Dr. Foss. NeuroTherapia intends to initially develop this product for the treatment of neurodegenerative diseases such as Alzheimer's Disease. About NeuroTherapia NeuroTherapia, Inc. is a Cleveland-based biotech company developing a novel small molecule, NTRX-07, for the treatment of neurodegenerative disorders. NTRX-07 is a small orally-available molecule that targets receptors known to increase in diseases including Alzheimer's disease (AD), ALS, MS and chronic pain syndromes. In various animal models of AD, NTRX-07 restored normal function of the microglia (key immune cells in the brain), which in turn decreased microglial-induced inflammation; reduced levels of the Alzheimer's associated Ab peptide in the brain; and substantially improved neuronal synaptic plasticity, learning, and memory. Additional information about NeuroTherapia can be found at www.neurotherapia.com.
September, 2020
NeuroTherapia Closes $8.8M Series A Financing Led by Brain Trust Accelerator Fund II
CLEVELAND, Sept. 22, 2020 /PRNewswire/ -- NeuroTherapia, Inc., a clinical-stage company focused on developing therapies for neurodegenerative diseases, announced today the closing of its Series A financing of $8.8M. The Series A round, led by Brain Trust Accelerator Fund II, included investments from The Cleveland Clinic Foundation, Dolby Family Ventures and Alzheimer's Drug Discovery Foundation. NeuroTherapia is developing an orally available cannabinoid receptor agonist, NTRX-07, for the treatment of neuroinflammation, which likely plays a critical role in the progression of neurodegenerative diseases. "We were particularly attracted to this novel strategy for inhibiting neuroinflammation," commented John Reher, managing director of Brain Trust and lead investor in this financing. "We believe that inhibiting neuroinflammation may be beneficial not only for treating neurodegenerative diseases but could also be an important strategy for treating other brain disorders such as glioblastoma." Coincident with the financing, the company welcomes Karoly Nikolich, Ph.D. to its Board of Directors. Dr. Nikolich is an experienced scientist and entrepreneur, co-founding a number of biotech companies, and currently serving as CEO of Alkahest. He also led Genentech's entry into neuroscience and served as a venture partner with Pivotal BioVenture Partners. Dr. Nikolich joins Mr. Reher, who will serve as Chairman of the Board, Tony Giordano, Ph.D., NeuroTherapia's President and CEO, and Akhil Saklecha, M.D., from Cleveland Clinic on the Board. NeuroTherapia is currently completing its first-in-human clinical trial using NTRX-07 with funding provided in part by a grant from the Alzheimer's Association. The company will use the Series A funds to finish this work while also undertaking a number of preclinical studies. The additional studies are designed to support subsequent clinical trials in subjects with neurodegeneration to show safety following longer-term administration, as well as to demonstrate biological activity. "We are extremely fortunate to have this tremendous group of venture capitalists working with us," said Dr. Giordano. "Their expertise in developing molecules for brain disorders is greatly appreciated and I look forward to working with them in advancing NTRX-07 and our emerging pipeline of products." NeuroTherapia also recently received a $150,000 Technology Validation and Start-up Fund grant from the Ohio Third Frontier program of the Ohio Development Services Agency, which will allow the Company to complete additional research on the biodistribution of NTRX-07 following radiolabeling of the molecule. About NeuroTherapia NeuroTherapia, Inc. is a Cleveland-based biotech company developing a novel small molecule, NTRX-07, for the treatment of neurodegenerative disorders. NTRX-07 is a small orally-available molecule that targets receptors that are known to be increased in diseases including Alzheimer's disease (AD), ALS, MS and chronic pain syndromes. In various animal models of AD, NTRX-07 restored normal function of the microglia (key immune cells in the brain), which in turn decreased microglial-induced inflammation, reduced levels of the Alzheimer's associated Ab peptide in the brain, and substantially improved neuronal synaptic plasticity, learning, and memory. Additional information about NeuroTherapia can be found at www.neurotherapia.com.
July 6, 2020
NeuroTherapia completes enrollment in Phase 1 first-in-human trial of NTRX-07
NeuroTherapia has completed enrollment of its Phase 1 single dose study of NTRX-07 in normal volunteers. Top line data is expected to be presented at the AAIC virtual meeting in July. The study is designed to provide initial safety data and human pharmacokinetics of NTRX-07 in preparation for planned upcoming trials in patients.
October 31, 2019
NeuroTherapia Initiates First-in-Human Clinical Trials of NTRX-07 for Alzheimer’s Disease
NeuroTherapia, Inc., a Cleveland Clinic spin-off company, has started its first-in-human Phase I clinical trial of NTRX-07, a new drug targeting the inflammation in the brain that is found in Alzheimer’s disease (AD) and other neurological diseases. The U.S. Food and Drug Administration (FDA) accepted their Investigational New Drug (IND) filing earlier this year, which allows NeuroTherapia to begin its first-in-human studies of NTRX-07 in an ascending dose study in normal, healthy volunteers. Based upon the data from this study, the company plans to follow with a study in patients with Alzheimer’s disease and other diseases such as amyotrophic lateral sclerosis (ALS) to explore the safety of repeated dosing of NTRX-07 and to look for changes in inflammation through studying biomarkers. “We are excited to initiate this Phase I study. We have strong evidence in preclinical models of Alzheimer’s disease and in chronic pain that NTRX-07 is a potential new approach to treating these challenging conditions,” commented Dr. Joseph Foss, the company’s co-founder and medical director. “This study will allow us to identify the safe dose, potential side effects and levels of the drug in the body. These results will then be used in the design of a Phase Ib study in patients to see how NTRX-07 is tolerated and to potentially demonstrate some early evidence of benefits.” Dr. Mohamed Naguib, the scientific advisor and the co-discoverer of NTRX-07, notes, “NTRX-07 is the first drug entering clinical trials that addresses the changes in the immune system of the brain brought about by inflammation. Inflammation plays a key role in neurodegenerative diseases, including AD, by damaging brain cells involved in memory and other functions. NTRX-07 has been shown to control inflammation in the brain in several different models of this disease.” This study is being supported by a generous grant from the Part the Cloud program of the Alzheimer’s Association. Drs. Naguib and Foss are entitled to a portion of any revenues Cleveland Clinic receives related to the technology. NTRX-07 is a small orally available molecule that targets receptors that increase in diseases including Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and chronic pain syndromes. In various animal models of AD, NTRX-07 restored normal function of the microglia (key immune cells in the brain) which in turn decreased microglial-induced inflammation, reduced levels of the Alzheimer’s associated A-beta peptide in the brain, and substantially improved neuronal synaptic plasticity, learning, and memory. About NeuroTherapia, Inc. NeuroTherapia, Inc. is a Cleveland-based biotech company, spun out of Cleveland Clinic in 2015, developing a novel small molecule, NTRX-07, for the treatment of Alzheimer’s disease. The Company has received financing from the Alzheimer’s Drug Discovery Foundation, Dolby Family Ventures and Cleveland Clinic, as well as grsnt funding from the Alzheimer’s Association. NTRX-07 acts by reducing neural inflammation and promoting neuronal survival.
October 13, 2019
NeuroTherapia to Start Clinical Trials of NTRX-07 For Alzheimer’s Disease
CLEVELAND, OH – NeuroTherapia, Inc., a Cleveland Clinic spin-off company, will be starting clinical trials of NTRX-07, a new drug targeting inflammation in the brain that is found in Alzheimer’s disease (AD) and other neurological diseases. The U.S. Food and Drug Administration (FDA) accepted the IND filing which allows NeuroTherapia to begin its first-in-human studies of NTRX-07 in an ascending dose study in normal healthy volunteers, which is scheduled to begin in mid-summer. Based upon the data from this study, the company plans to follow with a study in patients with Alzheimer’s disease to explore the safety of repeated dosing of NTRX-07 and to look for changes in inflammation by studying biomarkers. “The ability to begin studies in human subjects is a critical milestone for NeuroTherapia in its efforts to develop new treatments for patients with neurologic diseases for which there are currently no good therapies,” commented Dr. Joseph Foss, the company’s clinical advisor. “By identifying the safe dose in this study, we will be able to design a Phase Ib study in Alzheimer’s patients to see how NTRX-07 is tolerated and to potentially demonstrate some early evidence of benefits.” Dr. Mohamed Naguib, scientific advisor, and the co-discoverer of NTRX-07, also was excited about the ability to start first in human studies, “We have known for a long time that the immune system of the brain and inflammation play a key role in neurodegenerative diseases, including AD. NTRX-07 is the first drug entering clinical trials which addresses these changes. To be able to potentially help patients with this devastating disease makes all our efforts worthwhile.” Drs. Naguib and Foss are entitled to a portion of any revenues Cleveland Clinic receives related to the technology. NTRX-07 is a small orally available molecule that targets receptors that increase in diseases including Alzheimer’s disease, amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), and chronic pain syndromes. In various animal models of AD, NTRX-07 restored normal function of the microglia (key immune cells in the brain) which in turn decreased microglial-induced inflammation, reduced levels of the Alzheimer’s associated Ab peptide in the brain, and substantially improved neuronal synaptic plasticity, learning, and memory. About NeuroTherapia NeuroTherapia, Inc. is a Cleveland-based biotech company, spun out of Cleveland Clinic in 2015, developing a novel small molecule, NTRX-07, for the treatment of Alzheimer’s disease. The Company has received financing from the Alzheimer’s Drug Discovery Foundation, Dolby Family Ventures and Cleveland Clinic, as well as non-dilutive funding from the Alzheimer’s Association. NTRX-07 acts by reducing neural inflammation and promoting neuronal survival through the specific activation of cannabinoid type 2 (CB2) receptors expressed on activated microglia. NTRX-07 has also been demonstrated to be effective in various animal models of neuropathic pain.
June 13, 2019
Alzheimer’s Association Supports First in Human Trials of NTRX-07
NeuroTherapia has received funding from the Alzheimer's Association to support the first human trials of NTRX-07, a novel new therapy targeted towards inflammation in the brain and nervous system. The trial, set to begin in October, 2019, will study the pharmacology and safety of NTRX-07 in normal volunteers. The company plans to follow this study with a safety study in patients given NTRX-07 for up to one month. NTRX-07 blocks neuro-inflammation, which has been identified as a cause of injury to the brain in Alzheimer's disease and other neurodegenerative diseases. Neuro-inflammation also plays an important role in the development of chronic neuropathic pain which may occur after injury or treatment with some chemotherapy agents.
September 21, 2016
$1.7M ADDF Grant Supports Promising Drug that Targets Cannabinoid Receptor
NeuroTherapia, Inc. has received a $1.7 million commitment from the Alzheimer’s Drug Discovery Foundation (ADDF) to advance its drug NTRX-07 toward human clinical trials. This inventive therapy targets a cannabinoid receptor in the brain, which is a new approach for treating Alzheimer’s and other neurologic diseases. NeuroTherapia, a spin-off company created by Cleveland Clinic Innovations based on research by Drs. Mohamed Naguib and Joseph Foss, is developing new drugs that focus on microglia. These central nervous system immune cells can promote inflammation in the brain, which is a hallmark of Alzheimer’s, Parkinson’s, Huntington’s and other diseases. By targeting cannabinoid type 2 (CB2) receptors on microglia, NTRX-07 has shown the ability to lessen such neuroinflammation in pre-clinical disease models, protecting neurons from damage and death. “The protection of neurons from the damaging effects of inflammation caused by microglial over-activation is a novel approach to treating Alzheimer’s disease,” states Dr. Foss, Director, Clinical Research for General Anesthesiology at Cleveland Clinic and co-founder and Chief Medical Officer for NeuroTherapia. “We are excited to be partnering with the ADDF on the development of NTRX-07 for this devastating disease.” Multiple preclinical studies published by Dr. Naguib, Professor of Anesthesiology, Cleveland Clinic Lerner College of Medicine and co-founder and Chief Scientific Officer of NeuroTherapia, have demonstrated that NTRX-07 reduces neuroinflammation caused by microglia and limits the progression of Alzheimer’s disease. Treatment with the compound in mice restored cognition, memory and synaptic plasticity—a key foundation of learning and memory. With funding from the ADDF, NeuroTherapia will complete regulatory studies toward initiation of a clinical trial. “The Alzheimer’s Drug Discovery Foundation is committed to supporting new therapeutic approaches with the most potential to impact Alzheimer’s and other causes of dementia,” says Howard Fillit, MD, Founding Executive Director and Chief Science Officer at the ADDF. “Drugs that combat neuroinflammation are a major part of our research portfolio, and we look forward to working with the team at NeuroTherapia to advance NTRX-07.”
October 13, 2015
Cleveland Clinic Spin-off NeuroTherapia Targets Pain and Alzheimer’s Disease
A new Cleveland Clinic spinoff company has raised an initial $1 million to advance the development of a new therapeutic to take on Alzheimer’s and other neurological diseases. NeuroTherapia aims to commercialize NTRX-07, a drug that might be able to slow the symptoms of neurological diseases that are caused by inflammation. In animal trials, the compound has shown evidence of slowing the symptoms of neuro-inflammatory diseases. Though Alzheimer’s is the first disease target, the company also aims to treat pain that occurs in people who have suffered nerve damage. Other neuro-inflammatory diseases include Parkinson’s and multiple sclerosis. The compound, NTRX-07, is being developed by two Clinic doctors, Mohamed Naguib and Joseph Foss.
April 27, 2015
Alzheimer’s Drug Discovery Foundation Provides NeuroTherapia Funding to Advance Research
Sotheby's in New York City is famous for dealing in works of art and antiques,but at the Alzheimer’s Drug Discovery Foundation’s (ADDF) Connoisseur’s Dinner on April 27, 2015, it was scientists on the auction block. With Sotheby’s auctioneer Jamie Niven encouraging the charitable bidding, the lively “Fund a Scientist” auction generated more than $1 million to support the continued development of two unique Alzheimer’s drugs. The first drug, MDA7, developed by Drs. Joseph Foss and Mohamed Naguib of the Cleveland Clinic Foundation, minimizes inflammation in the brain and may block Alzheimer’s progression. There is mounting evidence that reducing inflammation is critical to protecting the brain from the insults of Alzheimer’s. With the money raised from the auction, Drs. Foss and Naguib hope to be able to conduct the safety research necessary to bring MDA7—which has already been tested extensively in animal models—to human clinical trials. “We are preparing to do the safety studies required by the FDA and plan on starting our first studies in humans next year,” explains Dr. Foss. “The funding we are getting now is essential to making the drug, getting it in a form that can be administered and finding the best and safest doses to use in the clinic.” In addition to providing critical financial support, the auction also served as a platform for Drs. Foss and Naguib to interact with potential funders as well as those affected by the devastating disease. “Everyone is being affected, some more directly than others, and I unfortunately have seen the effects of dementia in my own family,” says Dr. Foss. “Now that I am involved in the research, not only is the science rewarding, but the support of the ADDF and its supporters also provides inspiration to continue the work.” The ADDF bridges a critical funding gap in Alzheimer’s drug discovery research, supporting promising research projects that may be too risky or early stage to garner funding from governments and pharmaceutical companies. “We have enough data to support exploring the effects of MDA7 in man,” said Dr. Naguib. “To quote [the ADDF’s Founding Executive Director and Chief Science Officer] Dr. Howard Fillit, ‘The only real test for a new Alzheimer’s treatment is in humans.’” About the Alzheimer’s Drug Discovery Foundation Co-founded by Ronald S. and Leonard A. Lauder of the Estée Lauder cosmetics family, the mission of the Alzheimer’s Drug Discovery Foundation (ADDF) is to accelerate the discovery of drugs to prevent, treat and cure Alzheimer’s diseases, related dementias and cognitive aging. Since its founding, the ADDF has granted more than $70 million to fund over 450 Alzheimer’s drug discovery programs in academic centers and biotechnology companies in 18 countries. To learn more, visit www.AlzDiscovery.org. About NeuroTherapia NeuroTherapia is a Cleveland Clinic spin off company founded by Drs. Naguib and Foss to develop novel treatments for chronic pain and neurodegenerative diseases. MDA7 (also known as NTRX-07) is the first compound being advanced for the treatment of Alzheimer's Disease and neuropathic pain.