Newron Pharma Delays Schizophrenia Trials Over Safety Concerns

biospace | May 28, 2019

Switzerland-based Newron Pharmaceuticals announced that it is delaying its Phase II/III clinical trials of evenamide for schizophrenia based on concerns raised by the U.S. Food and Drug Administration (FDA).The agency expressed concern over the results of recently finished studies in rats and dogs that showed central nervous system (CNS) events that might have implications in humans. The FDA asked the company to delay the launch of the new studies until they had completed more short-term studies in rats and humans to address the safety issues.The company expects to have a meeting soon with the agency and then provide additional updates on the drug and plans for trials. “Based on the issues raised by the FDA letter,” stated Ravid Anand, Newron’s chief medical officer, “Newron is confident that they can be addressed satisfactorily.”Evenamide is a voltage-gated sodium channel blocker. It was developed internally from the company’s proprietary ion channel research program. In a Phase II trial, when added to two of the most commonly prescribed atypical antipsychotics in patients with chronic schizophrenia, it was safe and well-tolerated and showed efficacy in significantly improving symptoms of psychosis compared to placebo.The company’s other pipeline compounds include Xadago (safinamide), which has been on the market for more than a decade in the European Union, Switzerland and the U.S. as an adjunctive therapy in Parkinson’s disease. In addition, it is investigating sarizotan for Rett syndrome and ralfinamide for neuropathic pain. Sarizotan is the closest to approval.On February 1, the company completed patient enrollment in its STARS (Sarizotan for the Treatment of Apneas in Rett Syndrome) clinical trial. Newron plans to report top-line data from the trial in the fourth quarter of this year.Rett syndrome is a severe neuro-developmental disease that primarily affects girls beginning at a very young age. The disease is characterized by loss of acquired fine and gross motor skills and the development of neurological, cognitive and autonomic dysfunction, which leads to the loss of ability to walk, communicate or perform daily life activities. About a quarter of deaths in Rett syndrome patients are likely related to multiple cardio-respiratory dysrhythmias resulting from brain stem immaturity and autonomic failure.

Spotlight

In this challenging time, we need collaboration and innovation to address complex problems like the COVID-19 pandemic. At Certara, our global team is working with our partners to accelerate bringing scientifically-proven drugs to the patients who need them most.


Other News
BUSINESS INSIGHTS

Clearmind Medicine to Partner with Microdose for Psychedelic Capital

Clearmind Medicine Inc. | March 25, 2022

Clearmind Medicine Inc. a psychedelic medicine biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and undertreated health problems, announced that its CEO, Dr. Adi Zuloff-Shani and Mark Haden, VP Business Development, will be presenting in the Psychedelic Capital: March 2022 virtual event. While the presentation is live streamed, lifetime access to recordings will be available to all ticket holders. About Clearmind Medicine Inc. Clearmind is a psychedelic pharmaceutical biotech company focused on the discovery and development of novel psychedelic-derived therapeutics to solve widespread and underserved health problems, including alcohol use disorder. Its primary objective is to research and develop psychedelic-based compounds and attempt to commercialize them as regulated medicines, foods or supplements. The Company’s intellectual portfolio currently consists of four patent families. The Company intends to seek additional patents for its compounds whenever warranted and will remain opportunistic regarding the acquisition of additional intellectual property to build its portfolio.

Read More

BUSINESS INSIGHTS

Pack4U acquires leading pharmacy technology company Catalyst Healthcare

Pack4U | January 07, 2022

Pack4U, a connected health services company, acquires long-time technology partner Catalyst Healthcare whose patented AdhereNet® platform links pharmacists, patients, and care teams to effectively manage drug complexity and improve medication adherence. "We are dedicated to improving patient outcomes at scale. Bringing this domain knowledge in-house is vital for Pack4U. Catalyst's CEO Shane Bishop is a pharmacy thought leader and we are excited about building the next phase of Pack4U with the Catalyst team on board. Catalyst's proprietary and patented platform strengthens our ability to meet the needs of patients, providers and health plans by offering a full, end-to-end, connected care solution seamlessly integrated with our vast clinical team across all states." Pack4U President, Rahul Chopra Pack4U provides in-home and virtual services that connect patients with pharmacists for oversight, medication delivery, remote monitoring, and care coordination. Our complete suite of connected health IP fortifies Pack4U's ability to personalize care, improve health outcomes, and lower total cost of care across North America. "I am extremely excited to see these organizations come together and to join the team that is transforming in-home healthcare," said Shane Bishop. "Pack4U's extensive and diverse team of pharmacists combined with Catalyst's adherence solutions, create opportunity for a new patient monitoring paradigm. With central fills for scale and community pharmacy adoption, we will reach more people to change more lives." "This collaboration follows our aggressive growth in 2021. It expands our vision of in-home care via a full suite of managed services featuring patient specific, in-home medicine dispensing, always-on patient engagement, electronic medicine administration record and supply chain software for centralized filling," said Rahul Chopra. About Pack4U Pack4U Inc is a tech-enabled health services company. We connect people with community pharmacists to manage drug complexity and maximize health benefits through personalized medication delivery, virtual monitoring, and proactive care. Our fully automated, high-volume central fill pharmacy hubs, proprietary health platform and medication adherence network power a robust, scalable solution to chronic condition management that leads to better patient outcomes and total cost of care reduction.

Read More

PHARMACY MARKET

AIkido Pharma Reports Improved Manufacturing Process and New United States Patent for Pancreatic Drug

AIkido Pharma Inc. | March 04, 2022

AIkido Pharma Inc.reported an improvement in the manufacturing process for its pancreatic cancer drug, DHA-dFdC, licensed from the University of Texas at Austin. The Company also reported the issuance of an additional U.S. patent covering the drug, and the filing of a continuation patent application intended to expand patent coverage to other facets of the drug. With respect to manufacturing process, the Company reported the successful development of a new means for the scaled production and isolation of the key intermediate compound in the manufacture of DH-dFdC. The Company has now executed a further contract with its contract manufacturing organization, Parimer Scientific, to employ the new process to produce several thousand milligrams of the drug for use in formulation development and stability studies. The Company also reported that the U.S. Patent Office recently issued new U.S. Patent No. 11,219,633, which provides additional intellectual property protection for the drug compound. The term of the patent is expected to continue until May of 2035 with the payment of required maintenance fees. Prior to the patent issuance, the Company authorized the timely filing of a patent continuation application, U.S. Serial No. 17/539,682, in which additional claims related to various aspects of the drug and formulation will be pursued. "This new process significant step forward in the development of our pancreatic cancer drug and should permit production of the drug on a commercial scale at a lower cost. I am also pleased that we can continue to report expansion of the patent estate." Anthony Hayes, CEO of AIkido Richard T. Pace, Owner and Principal Scientist of Parimer Scientific, stated, "The newly developed manufacturing method is a large step forward for this innovative technology. I believe it will reduce cost per unit and at the same time increase batch production volumes." About AIkido Pharma Inc. AIkido Pharma Inc. was initially formed in 1967 and is a biotechnology Company with a diverse portfolio of small-molecule anticancer and antiviral therapeutics. The Company's platform consists of patented technology from leading universities and researchers, and we are currently in the process of developing an innovative therapeutic drug platform through strong partnerships with world renowned educational institutions, including The University of Texas at Austin and University of Maryland at Baltimore. Our diverse pipeline of therapeutics includes therapies for pancreatic cancer, prostate cancer. We are constantly seeking to grow our pipeline to treat unmet medical needs in oncology. The Company is also developing a broad-spectrum antiviral platform that may potentially inhibit replication of multiple viruses including Influenza virus, SARS-CoV (coronavirus), MERS-CoV, Ebolavirus and Marburg virus.

Read More

PHARMACY MARKET

Theralink® Technologies Expands Adoption of its Precision Medicine Technology in the Biopharmaceutical Industry

Theralink Technologies | April 20, 2022

Theralink Technologies a precision medicine company with a novel phosphoprotein-based assay for breast cancer, today announced that it has significantly expanded the adoption of its Laser Capture Microdissection and Reverse Phase Protein Array precision medicine technology to biopharmaceutical companies, including multinational healthcare corporations. The Company has supported 41 preclinical and clinical studies for 18 biopharma companies and is currently undergoing discussions to develop Companion Diagnostics with several of its existing clients. "We have partnered with some of the largest and most innovative global biopharma companies, driven by the unique value of our patented phosphoprotein precision medicine technology and our dedicated Theralink team of experts. I am encouraged by the rapid uptake of our biopharma offerings and excited by the significant market potential to develop Companion Diagnostics–tests required for oncologists to prescribe targeted drug therapy. We look forward to further expanding our technology across the industry to help bring life-saving therapies to patients in need, as well as equipping oncologists with insights to develop targeted treatment programs for their patients." Mick Ruxin, M.D., President & CEO of Theralink Technologies Leveraging its novel phosphoprotein-based assay, Theralink enables biopharma clients to expedite drug development and ultimately shorten time to market, which can potentially save millions of development dollars, by providing invaluable insights into a drug's biological impact. Theralink supports its partners across the entire drug development continuum from discovery to clinical market with services including: phosphoproteomic profiling in preclinical models and clinical samples, the evaluation of drug target inhibition within laser capture microdissected tumor samples, and interrogation of compensatory feedback mechanisms and pathways after drug target inhibition. In addition, the Company is in early discussions with several biopharma companies for the development of Companion Diagnostics. The development of Companion Diagnostics using Theralink's assays is a potentially large catalyst for Theralink, as well as its biopharma partners, as it is a required test by oncologists to determine a drug's suitability for their cancer patients. About Theralink Technologies, Inc. Theralink Technologies is a proteomics-based, precision medicine company with a CLIA-certified laboratory located in Golden, Colorado. Through its unique and patented phosphoprotein and protein biomarker platform and LDTs, Theralink's technology targets multiple areas of oncology and drug development. Theralink provides precision oncology data through its powerful Theralink® Reverse Phase Protein Array assays to assist the biopharmaceutical industry and clinical oncologists in identifying likely responders and non-responders to both FDA-approved and investigational drug treatments. Theralink intends to help improve cancer outcomes for patients, help reveal therapeutic options for oncologists, and support biopharmaceutical drug development by using a beyond-genomics approach to molecular profiling that directly measures drug target levels and activity.

Read More