Xeris | November 24, 2022
Xeris Biopharma Holdings, Inc. a growth-oriented biopharmaceutical company committed to improving patient lives by developing and commercializing innovative products across a range of therapies, announced that it has entered into a research collaboration and option agreement with Horizon Therapeutics plc. Under the terms of the agreement, Xeris will use its proprietary formulation technology platform, XeriJect™, to develop an ultra-concentrated, ready-to-use, subcutaneous injection of teprotumumab and Horizon will have an option to license the Xeris technology. Teprotumumab is the first and only medicine approved by the U.S. Food and Drug Administration for the treatment of Thyroid Eye Disease a serious, progressive and potentially vision-threatening rare autoimmune disease. Teprotumumab-trbw is known as TEPEZZA® in the United States. Xeris will receive an upfront payment, and may be entitled to receive development milestones, regulatory milestones, and salesbased milestones, as well as royalties based on future sales if the commercial license option is exercised. Specific financial terms of the agreement were not disclosed.
“We are excited to announce our collaboration with Horizon for the development of a subcutaneous formulation of teprotumumab using our XeriJect technology to potentially enhance the patient experience and delivery of the treatment for Thyroid Eye Disease. This partnership demonstrates the potential value of our technology to enable large molecule subcutaneous injections that provide a more patient friendly regimen that is effective, safe, and more convenient, with potential for improved adherence.”
Paul R. Edick, Chairman and CEO of Xeris
XeriJect formulations are innovative, ready-to-use, viscoelastic pharmaceutical suspensions that have the potential to improve drug delivery, lower treatment burden and improve patients' lives across a broad range of therapeutic categories. XeriJect suspensions maximize drug loadings at >400mg/mL, enable small volume subcutaneous injections and do not settle on storage. The suspensions use FDA-approved excipients and leverage known manufacturing processes. XeriJect formulation technology is well suited for drugs and biologics including large molecules such as proteins, monoclonal antibodies, and vaccines. The technology is protected by an extensive patent estate, trade secrets and know-how, and it is available for licensing.
Xeris is a growth-oriented biopharmaceutical company committed to improving patients’ lives by developing and commercializing innovative products across a range of therapies. Xeris has three commercially available products; Gvoke®, a ready-to-use liquid glucagon for the treatment of severe hypoglycemia, Keveyis®, the first and only FDA-approved therapy for primary periodic paralysis, and Recorlev® for the treatment of endogenous Cushing’s syndrome. Xeris also has a robust pipeline of development programs to extend the current marketed products into important new indications and uses and bring new products forward using its proprietary formulation technology platforms, XeriSol™ and XeriJect™, supporting long-term product development and commercial success.
BUSINESS INSIGHTS, PHARMACY MARKET
RespireRX Pharmaceuticals Inc. | December 06, 2022
RespireRx Pharmaceuticals Inc. a leader in the discovery and development of innovative and revolutionary treatments to combat diseases caused by disruption of neuronal signaling, is pleased to announce that RespireRx has been accepted into the NIH HEAL Initiative® NINDS Preclinical Screening Platform for Pain program.
The Company’s lead GABAkine, KRM-II-81, has been shown to be effective in relieving acute, chronic, and neuropathic pain in a number of models without tolerance development or sedation.
The Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, is an aggressive, trans-agency effort to speed scientific solutions to stem the national opioid public health crisis. Launched in April 2018, the initiative is focused on improving prevention and treatment strategies for opioid misuse and addiction, and enhancing pain management.
The PSPP program, part of the NIH HEAL Initiative, evaluates non-opioid assets in a battery of established preclinical models. The PSPP program accepts small molecules, biologics, devices, or natural products for evaluation, from researchers in academia and industry worldwide.
The RespireRx team is led by Dr. Arnold Lippa, RespireRx Executive Chairman and Chief Scientific Officer and Drs. James M. Cook, Jeffrey M. Witkin and Rok Cerne, all of whom are RespireRx Research Fellows in addition to their academic affiliations at University of Wisconsin-Milwaukee, Ascension St. Vincent and Indiana University/Purdue University, respectively. The team has extensive expertise in drug discovery and development including the development of novel analgesic drugs and an extensive publication record with a combined total of over 1,000 scientific publications. The team has already profiled KRM-II-81 activity in a broad range of preclinical studies where it has displayed a high degree of analgesic activity and is excited at the prospect of advancing the Companay’s lead GABAkine toward clinical development. In cellular studies, KRM-II-81 preferentially bound to specific subtypes of GABAA receptors and boosted the ability of GABA to inhibit pain sensory neurons in the spinal dorsal root ganglia. In intact animal models of acute and chronic pain, the analgesic efficacy of KRM-II-81 was comparable to or greater than commonly used analgesics. At the same time, KRM-II-81 did not display side effects such as sedation and motor impairment, but even more importantly, it did not produce tolerance, dependence, respiratory depression, or behavioral changes indicative of abuse liability, which are produced by opioid narcotics and are at the heart of the opioid epidemic.
Unrelated to the NINDS project, KRM-II-81 has also shown promising results in multiple animal models of treatment resistant epilepsy and in human translational studies by reducing epileptiform electrical signaling in brain tissue removed from treatment resistant epileptic patients undergoing surgery.
Dr. Cerne commented “We believe that the expansion of our understanding of GABAA receptor structure and function has created a new surge in the discovery and development of GABAkines that target such receptors in a unique manner. This opens the promise of improved medicines for pain, epilepsy and other disorders caused by disruption of neuronal signaling.”
“We are very excited about developing KRM-II-81 and expanding the IND enabling studies so as to begin human studies. Pending clinical validation, we believe that KRM-II-81 has the potential to represent a breakthrough treatment for pain, epilepsy, and other neuropsychiatric disorders.”
About RespireRx Pharmaceuticals Inc.
RespireRx Pharmaceuticals Inc. is a leader in the discovery and development of medicines for the treatment of psychiatric and neurological disorders, with a focus on treatments that address conditions affecting millions of people, but for which there are few or poor treatment options, including attention deficit hyperactivity disorder epilepsy, pain, recovery from spinal cord injury ertain neurological orphan diseases and obstructive sleep apnea. RespireRx is developing a pipeline of new and re-purposed drug products based on our broad patent portfolios for two drug platforms: (i) pharmaceutical cannabinoids, which include dronabinol, a synthetic form of ∆9-tetrahydrocannabinol that acts upon the nervous system’s endogenous cannabinoid receptors and (ii) neuromodulators, which include AMPAkines and GABAkines, proprietary chemical entities that positively modulate AMPA-type glutamate receptors and GABAA receptors, respectively.
The Company holds exclusive licenses and owns patents and patent applications or rights thereto for certain families of chemical compounds that claim the chemical structures and their uses in the treatment of a variety of disorders, as well as claims for novel uses of known drugs.
GABAkines. Under a License Agreement with the University of Wisconsin-Milwaukee Research Foundation, Inc. and on behalf of its EndeavourRx business unit, RespireRx has licensed rights to certain selectively acting GABAkines because of their ability to selectively amplify inhibitory neurotransmission at a highly specific, subset of GABAA receptors, thus producing a unique efficacy profile with reduced side effects. Preclinical studies have documented their efficacy in a broad array of animal models of interrelated neurological and psychiatric disorders including epilepsy, pain, anxiety, and depression in the absence of or with greatly reduced propensity to produce sedation, motor-impairment, tolerance, dependence and abuse. The Company currently is focusing on developing KRM-II-81 for the treatment of epilepsy and pain.
BUSINESS INSIGHTS, PHARMA TECH
Elligo Health Research | January 25, 2023
On January 24, 2023, Elligo Health Research®, the leading healthcare-enabling research organization, presented the DataAI Connect, a new data and technology platform that will facilitate data-driven, rapid clinical research. DataAI Connect, a scalable, end-to-end data platform, optimizes the clinical research workflow by decreasing human error and rapidly digesting patient data to speed up clinical studies.
Elligo has created an industry-first AI-driven platform that sources, processes, analyses, and distributes patient real-world data (RWD) by bringing together data, processes, and clinical expertise. That means an end-to-end solution that solves clinical trial issues directly rather than being an add-on technology. The platform is adaptable and reusable, and it includes the following
An RWD repository of electronic health records (EHRs) and clinical data storage that incorporates EHR, clinical trial, and patient data for analytics, artificial intelligence (AI), and research
A comprehensive medical records retrieval and analytics solution that transforms data into searchable, actionable insights and personalized patient journey information within minutes using NLP, ML, and clinical experience.
A data-driven protocol development service that puts designs to the test in the real world.
Elligo's Chief Data Officer, Michael Ibara, commented, "The application of AI approaches to healthcare and clinical study data is moving from the moon-shot approach to more practical applications." He added, "An example of this approach is the process of getting patients' medical records, which involves manual, non-scalable activities such as getting accurate information on patients' providers, asking sites to track down records, and having humans triage hundreds of pages of medical records. The judicious and intelligent application of natural language processing (NLP), machine learning (ML), and other AI approaches increases speed, accuracy and quality, while removing the burden from the sites and patients."
(Source – Business Wire)
About Elligo Health Research
Founded in 2016, Elligo Health Research® is a leading healthcare-enabling clinical research organization. With access to known patients and their HIPAA-compliant healthcare data, its IntElligo® Research Stack technology and eSolutions Research Accelerator PatientSelect approach expedite clinical trials through healthcare. Elligo's Site Solutions, combined with the largest Known Patient Access Network, enable healthcare practices and research sites to engage in clinical studies. Its services expedite the development of novel pharmaceutical, biotechnology, medical device, and diagnostic products through the adaptive involvement of known patients and clinicians.