NIH Awards NeurOp $3.5 Million to Support Phase 1 Clinical Trial of NMDA Inhibitor NP10679

NP10679 is in development to prevent brain ischemia during stroke or subarachnoid hemorrhage

NeurOp, Inc. today announced that it has received a $3.5 million award from the National Institute of Neurological Disorders and Stroke (NINDS), a division of the NIH, to begin clinical testing of the Company’s drug candidate NP10679, a GluN2B subunit-specific NMDA (N-methyl-D-aspartate) inhibitor. NeurOp is investigating NP10679 for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage (SAH).

“We designed NP10679 with great care to incorporate the attributes we believe differentiate this molecule from other NMDA inhibitors in development,” said Barney Koszalka, PhD, NeurOp CEO. “For example, the binding of the molecule is enhanced in an acidic environment, a property other NMDA inhibitors lack. This property of pH dependence improves the chance of achieving efficacy at dose levels devoid of side effects. We would like to partner with a pharmaceutical company in future trials to fully explore this advantage in an array of disorders such as stroke, treatment-resistant depression and neuropathic pain.”

NP10679 is bioavailable by either the oral or IV route, and it will initially be evaluated in a Phase 1 study in healthy human volunteers by the IV route. The study is expected to start in early 2018. Pre-clinical studies have shown efficacy in treating complications associated with SAH. An IND for NP10679 was opened in 2016.

NeurOp’s Chief Scientific Officer, Robert Zaczek, PhD, added, “The safety profile of NP10679 allows for prophylactic use in patients at risk for an ischemic event, such as those suffering an SAH. This is important because extensive data has shown that early intervention is key for robust efficacy of neuroprotective therapy. Our prophylactic intervention strategy will place NP10679 at its site of action before an SAH-driven delayed cerebral ischemia event takes place. This eliminates the time-of-dosing caveat that might, in part, have led to previous failures of clinical tests involving glutamatergic agents in stroke and head trauma.”

Note: Research reported in this news release is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health (NIH) under Award Number R44NS071657. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia and Parkinson’s disease. Its research targets specific subunits of neuronal NMDA receptors to identify and evaluate small molecule modulators for potential therapeutic benefit. Multi-year funding from the NIH supports the Company’s research and development programs for NP10679 for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp contact:
Barney Koszalka, PhD, CEO

Letter to Shareholders | 2015 Highlights

As we have in previous years, I’m writing to update you on the progress we have made this past year and the direction NeurOp is heading for the remainder of 2016 and into 2017.  We will continue to update our website with current information (www.neuropinc.com ) and events and also invite you to join our LinkedIn page. This year has proven to be a challenge, and our lead compound, NP10679, is on track to have an open IND by the summer’s end. The support for this program from the NIH remains strong, and we are confident of continued support from this agency to initiate Phase I trials. Feel free to reach out to me with any questions.

Regards,
Barney Koszalka, PhD
President and CEO
NeurOp, Inc.

Biotech Showcase 2016 | San Francisco

NeurOp will present at the 8th Annual Biotech Showcase 2016 in San Francisco, CA to be held January 11-13th. Biotech Showcase is an investor and networking conference devoted to providing private and public biotechnology and life sciences companies with an opportunity to present to, and meet with, investors and pharmaceutical executives at one of the industry’s largest annual healthcare investor conferences.

Tuesday, January 12, 2016
9:30 am PT
Track: A – Hearst

Biotech Showcase 2016
Parc 55 San Francisco – Union Square
55 Cyril Magnin St., 4th Floor
San Francisco, CA  94102

NeurOp’s Lee Latimer Elected to ACS 2016 Board of Directors

NeurOp, Inc. today announced that Lee H. Latimer, Ph.D., head of chemistry, has been elected as Director-at-Large for the American Chemical Society’s (ACS) 2016 Board of Directors. The Society announced election results on November 5.

Dr. Latimer has been a member of ACS since 1972 and became an ACS Fellow in 2012. He has held leadership positions at the local and national level of the organization and been recognized with a number of awards for his contributions.

“ACS is about opportunity for its members in so many ways. It has certainly been so for me. I enjoy meeting new challenges and colleagues in teams and applying my experience to make a difference,” said Latimer.

Dr. Latimer earned his Ph.D. in organic chemistry from the University of Wisconsin under the mentorship of B.M. Trost and held an NIH Fellowship with W.G. Dauben at the University of California at Berkeley and C.J. Sih at the University of Wisconsin at Madison. To learn more about Dr. Latimer’s extensive professional experience, click here.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has licensed its technology to Bristol-Myers Squibb for the development of a compound for treatment-resistant depression. Multi-year funding from the NIH supports the company’s research and development programs for schizophrenia, Alzheimer’s disease and NP10679, its drug candidate for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp contact:
Barney Koszalka, CEO
Phone: (919) 260-5595

Letter to Shareholders | 2014 Highlights

Dear NeurOp Shareholder:

I want to update you on the substantial progress we made in the last year and the opportunities we see in front of us for 2015 and beyond. Our drug discovery efforts, focused on the NMDA receptor, have yielded two development candidates that will advance in 2015. I am pleased to share that we reached a significant milestone in our collaboration with Bristol-Myers Squibb (BMS) in the area of depression. BMS selected a development candidate, which triggered a milestone payment to NeurOp. In addition, the NIH continues to show strong support and enthusiasm for our subarachnoid hemorrhage (SAH) program, because they see intervention in this indication as a major unmet medical need.

In addition to moving these programs toward clinical testing, we made progress in identifying promising new applications for NMDA modulators outside those targeted for SAH and depression. NeurOp began a research collaboration with Janssen Pharmaceuticals to identify molecules that may yield further medical applications of NMDA receptor modulation.

Depression
Since BMS internalized the depression program in 2013, our access to information on the progression of the program is limited. However, in late June, BMS elevated compound NP11948 to development status. They are now evaluating the compound in the necessary experiments to file an Investigational New Drug (IND) application with the FDA. Typically, one would expect to this work to be completed in 2015, and we are hopeful that will be the case.

Ischemia & Addiction
NP10679, a compound meant to ameliorate or prevent brain damage and its clinical manifestations in those receiving treatment for SAH, met criteria set by us and the NIH to qualify it as a development candidate in 2013. Results from advanced pre-clinical studies performed in 2014 support the continued development of this molecule. Of significance, NP10679 showed a durable effect in animal studies. This observation, coupled with successful scale-up synthesis of drug substance and pre-IND cardiovascular studies, led us to a meeting with the FDA to review our planned submission to begin human testing.

The FDA review of the program reinforced our plan to move this program forward with all possible speed. The NIH granted additional funding of almost $400,000 to support our pre-IND studies, which brings the investment in this stage of the program to over $1.6 million for this year. We anticipate an IND filing in late 2015.

Last year, we mentioned an investigation of our compound’s ability to influence addiction – specifically, reducing the cravings associated with nicotine and opiate addiction. NeurOp conducted this research in collaboration with a leading researcher at the Medical University of South Carolina. The experimental findings in animals were positive in lessening cravings. These data suggest clinical application of NP10679 beyond SAH, and we are currently formulating an experimental strategy to enhance the compound’s value.

Further Leveraging the NMDA Platform
The NeurOp-Emory University collaborative research program helped us form another partnership with big pharma this past year. Janssen Pharmaceuticals and NeurOp entered into a short-term research agreement to find molecules that inhibit the NMDA receptor through GluN2C and/or GluN2D subunits. Although the program is in its early stages, we are encouraged and making progress to meet the yearly objectives for the program.

Looking Forward In 2015/16, we anticipate that the BMS depression program should reach a second milestone and trigger an additional payment to NeurOp. We will also continue our early drug discovery efforts by working to extend our agreement with Janssen and pursue an additional large pharma collaboration to identify NMDA modulators outside our current scope.

We expect that the ischemia program for NP10679 will have an approved IND and enter into clinical trials once we obtain funding. Despite having adequate funding to meet our 2015 objectives and complete the remaining studies required to file the IND, we will be unable to begin clinical trials without additional funds. NINDS, the division of the NIH that has supported the SAH program to date, has a limited budget for the initial Phase I trials we plan to start in 2016. While we will submit a grant application for this early clinical work, the total cost of the program is not likely to be covered. Securing additional funding remains a top priority for us.

The scientific news around modulating the NMDA receptor continues to be very positive, and NeurOp is entering a new and exciting phase in its evolution. We are energized by the potential of providing new medicines for unmet medical needs in many underserved areas of neuroscience, while at the same time growing value for our company.

I look forward to updating you throughout the year on our progress.

Very sincerely yours,

George Koszalka, Ph.D.
President and Chief Executive Officer, NeurOp, Inc.

NeurOp is committed to keeping you informed of our progress. We are working to launch a new website in the next few months that will allow us to share news, events and publications in a more timely, mobile-friendly format. You may sign up on our website to receive our latest news through an RSS feed. We also post news to our LinkedIn page, so you may wish to follow us there.

 

 

NeurOp Announces Strategic Collaboration with Johnson & Johnson Innovation to Study Role of NMDA Receptors

NeurOp, Inc. today announced that it has entered into a research collaboration with Janssen Pharmaceuticals, Inc. to better understand how modulating the NMDA (N-methyl-D-aspartate) receptor impacts pathways related to different central nervous system disorders.

Under the agreement, which was facilitated by the Johnson & Johnson Innovation Center in Boston, NeurOp and Janssen will focus specifically on the modulation of the 2C and 2D subunits of the NMDA receptor and their potential to impact central nervous system disorders such as depression. Financial terms of the agreement were not disclosed.

“Glutamate signaling through NMDA receptors is one of the most important processes in normal brain function, particularly in emotional processing,” said Barney Koszalka, Ph.D., NeurOp CEO. “NeurOp and Janssen see this as a tremendous opportunity to investigate the use of NMDA modulators, which could lead to new treatments for patients afflicted with a number of central nervous system disorders.”

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has licensed its technology to Bristol-Myers Squibb for the development of a compound for treatment-resistant depression. Multi-year funding from the NIH supports the company’s research and development programs for schizophrenia, Alzheimer’s disease and NP10679, its drug candidate for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp contact:
Barney Koszalka, Ph.D., CEO
Phone: (919) 260-5595

 

NeurOp Receives Milestone Payment as Bristol-Myers Squibb Nominates NMDA Receptor Compound as Drug Development Candidate

NeurOp, Inc. today announced that Bristol-Myers Squibb has selected an NR2B-specific N-methyl-D-aspartate (NMDA) receptor modulator as a drug development candidate for treatment-resistant depression. This decision triggers a milestone payment to NeurOp, which licensed its technology to Bristol-Myers Squibb in 2009. The compound can now advance into pre-IND studies.

“The team at Bristol-Myers Squibb has been a dedicated, insightful research partner as we have worked together for more than three years to identify and advance a new drug candidate,” commented Barney Koszalka, Ph.D., NeurOp president and CEO. “Reaching this clinical and financial milestone is important to NeurOp, because it will help support our R&D on additional subunits of the NMDA receptor as treatments for other central nervous system disorders.”

Under the terms of the agreement, Bristol-Myers Squibb agreed to pay NeurOp an upfront fee and fund a multi-year research collaboration. The direct research collaboration ended in December 2012, and the program was fully internalized at Bristol-Myers Squibb. NeurOp is eligible to receive additional milestone payments for the successful development of a compound and royalties on worldwide sales of commercialized compounds. Financial terms of the current milestone were not disclosed.

About Treatment-Resistant Depression
Unlike normal emotional experiences of sadness, loss or passing mood states, major depressive disorder (MDD) is persistent and can significantly interfere with thoughts, behavior, mood, activity and physical health. According to the National Institute of Mental Health, MDD is the leading cause of disability in the U.S. for people aged 15 to 44 and affects almost 15 million adults, or about 6.7 percent of the population in a given year. Up to 15 percent of people with MDD die by suicide. About one-third of people suffering from depression do not get relief from first-line antidepressant medications. Of significant concern is the fact that even when effective there is a delay in onset of action of two weeks or more, during which time patients are at increased risk of suicide.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has licensed its technology to Bristol-Myers Squibb for the development of a compound for treatment-resistant depression. Multi-year funding from the NIH supports the company’s research and development programs for schizophrenia, Alzheimer’s disease and NP10679, its drug candidate for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp contact:
Barney Koszalka, CEO
Phone: (919) 260-5595

 

NeurOp Awarded NIH Grant for Alzheimer’s Disease Drug Research

NeurOp, Inc. announced today that the National Institutes of Health (NIH) has awarded it a grant to support research on new Alzheimer’s disease treatments. NeurOp is investigating subunit-selective N-methyl D-aspartate (NMDA) receptor compounds as potential therapeutics. The grant is a one-year award and will be conducted in collaboration with Dr. Jon Johnson at the University of Pittsburgh.

“Alzheimer’s disease has devastating effects on patients and their families,” said Barney Koszalka, Ph.D., NeurOp president and CEO. “Our research suggests that targeting specific subunits of NMDA receptors may lead to a new generation of drugs that may enhance cognitive performance, as well as impact the progression of other diseases of the central nervous system. This is the third grant we’ve received from the NIH to fund research based on our NMDA receptor modulation platform, and we look forward to further exploring the potential it has for patients.”

This project is supported by the National Institute on Aging of the National Institutes of Health under award number R41AG048723.

About NeurOp
NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has licensed its technology to Bristol-Myers Squibb for the development of a compound for treatment-resistant depression. Funding from the NIH supports the company’s research and development programs for schizophrenia, Alzheimer’s disease and NP10679, its drug candidate for the prevention of ischemic damage during a stroke or subarachnoid hemorrhage. For more information, please visit www.neuropinc.com.

NeurOp contact:
Barney Koszalka, CEO
Phone: (919) 260-5595

Lee H. Latimer Joins NeurOp to Manage Its Chemistry Operations

NeurOp, Inc. announces that Lee H. Latimer, Ph.D., has been appointed as its head of chemistry. He will oversee the company’s chemistry program to support its drug development initiatives for the treatment of depression, neuropathic pain, ischemia (stroke), schizophrenia and other central nervous system disorders.

Dr. Latimer was most recently a consultant to the pharmaceutical and biotechnology industries and provided expertise in process, analytical and medicinal chemistry. Prior to that, he was the senior director of process and analytical chemistry at Elan Pharmaceuticals. He successfully led in-house and outsourced oversight and development of GMP routes to five clinical candidates in its Alzheimer’s disease and multiple sclerosis programs. Dr. Latimer is also an inventor of semagacestat, which reached phase III clinical trials for Alzheimer’s disease in collaboration with Eli Lilly.

“Lee brings a wealth of development experience to NeurOp at a time when our internal programs are advancing into clinical development,” said Barney Koszalka, Ph.D., president and CEO at NeurOp. “His work in early-stage medical chemistry programs will also greatly contribute to our ongoing efforts to develop new modulators of the NMDA receptor through our collaboration with Emory University.”

Dr. Latimer earned his Ph.D. in organic chemistry from the University of Wisconsin under the mentorship of B.M. Trost and held an NIH Fellowship with W.G. Dauben at the University of California at Berkeley and C.J. Sih at the University of Wisconsin at Madison. He is an American Chemical Society Fellow.

About NeurOp

NeurOp, Inc. is an Atlanta-based biopharmaceutical company developing new medicines for central nervous system disorders, including depression, neuropathic pain, ischemia (stroke), schizophrenia, and Alzheimer’s and Parkinson’s diseases. Its research targets various subunits of neuronal NMDA receptors and their potential therapeutic benefit. The company has a research collaboration and licensing agreement with Bristol-Myers Squibb for the development of NeurOp’s compounds for the treatment of depression and neuropathic pain. Multi-year funding from the NIH supports the company’s research and development programs for schizophrenia and NP10679, its drug candidate for the prevention of ischemic damage. For more information, please visit www.neuropinc.com.

NeurOp contact:

Barney Koszalka, CEO
Phone: 404.941.2350