Image Credit: Adobe Stock Images/Creative Cat Studio Data from the Phase II KINETIC 2 study, which evaluated SAGE-324 (BIIB124) as a treatment for essential tremor (ET), show the drug did not achieve the trial’s primary objectives. According to Sage Therapeutics and Biogen, the study aimed to determine the dose-response relationship of SAGE-324 by assessing changes from baseline to day 91 in the TETRAS Performance Subscale Item 4 total score, measuring upper limb tremor severity. Results found that SAGE-324 offered no statistically significant improvement across different doses compared to placebo. As a result, both companies have decided to halt the ongoing open-label safety study and cease further clinical development of SAGE-324 for ET.1 “There has been little innovation in the pharmacological treatment of essential tremor over the past 50 years, and people living with this debilitating condition have a pressing need for new treatment options. We are disappointed that the results ...
In a Perspective, Daniel Drucker highlights the growing body of evidence that hints at the potential of glucagon-like peptide-1 (GLP-1)-based medications in treating conditions other than diabetes and obesity, including cardiovascular disease and neurodegenerative disorders. GLP-1 is a hormone released from the gut after eating that enhances glucose-dependent insulin secretion. Pharmacological GLP-1 receptor (GLP-1R) activation reduces glucagon secretion and slows gastric emptying, making it an effective treatment for type 2 diabetes. Later studies found that GLP-1 administration also inhibited food intake through GLP-1R activation in the brain, leading to their use in treating obesity. Recently, research has demonstrated that GLP-1 drugs produce additional health benefits beyond glucose and weight control, including reduced heart and kidney diseases. Here, Drucker discusses the potential mechanisms underlying these benefits, such as reducing systemic inflammation, and their implications for future clinical applications and drug development. According to Drucker et al., GLP-1 drugs have shown promise ...
By Don Tracy, Associate Editor Clearance of the NeuroLF Brain PET system marks Positrigo’s first device of its kind to be approved in the United States.The FDA has granted clearance to Positrigo’s NeuroLF brain positron emission tomographic (PET) system, which the company said represents a major advancement in functional brain imaging. The device is designed to diagnose and monitor brain disorders such as Alzheimer disease, brain tumors, epilepsy, and Parkinson disease. As the company’s first brain PET system approved in the United States, Positrigo is currently preparing for global market expansion, with European regulatory approval anticipated later this year.1 “It is not the first device of its kind which receives market clearance in the US, but we believe that our patient-centric and customer-driven design and development efforts over the last couple of years, brought us into the pole position to offer the best imaging solution to address the increased demand ...
Novo Holdings led Asceneuron’s $100 million Series C financing. The Merck Serono spinout’s lead program is an oral small molecule designed to prevent aggregation of tau protein in neurodegenerative disorders. By Frank Vinluan Alzheimer’s disease patients can now choose between new two intravenously infused therapies that work by breaking up plaques of amyloid protein in the brain. Asceneuron takes a different approach with oral therapies that address the buildup of tau, a protein that’s also associated with the neurodegenerative disorder. The biotech now has $100 million to advance its lead program to Phase 2 testing. The Series C financing announced Tuesday was led by Novo Holdings, the company that manages the assets of the Novo Nordisk Foundation, the controlling shareholder of metabolic drug giant Novo Nordisk. Using a drug to target and break up pathological proteins associated with Alzheimer’s has been validated by Eisai’s Leqembi, approved by the FDA last year, ...
Two months after MSD (Merck & Co) set its eye on acquiring Eyebiotech (EyeBio), the former has closed the deal, making EyeBio its subsidiary. MSD has acquired all outstanding shares of the privately held UK-based biotech through a subsidiary as part of the agreement. EyeBio’s shareholders will receive approximately $0.50 per share, totalling $1.3bn. Following the acquisition, MSD has gained access to EyeBio’s lead asset Restoret (EYE-103), a tetravalent, tri-specific antibody that targets the Wingless-related integration site (Wnt) signalling pathway. A Phase IIb/III trial investigating Restoret in patients with DME is expected to begin in H2 this year. In February, EyeBio reported positive data from the Phase Ib/IIa AMARONE trial (NCT05919693) in patients with treatment-naïve diabetic macular oedema (DME) and treatment-naive neovascular age-related macular degeneration (AMD). In the study, Restoret improved vision in 26 participants with DME, leading to an improved best-corrected visual acuity by +11.2 letters and a mean ...
Progressive supranuclear palsy (PSP) is a severe neurological disorder classified under frontotemporal dementia (FTD) that impairs cognition, movement, and behavior. Thought to be caused by an accumulation of tau proteins that damage and kill cells, PSP presents symptoms such as poor balance with frequent backward falls and difficulties moving the eyes vertically. Often misdiagnosed as Parkinson’s disease, PSP progresses more rapidly and does not respond to Parkinson’s treatments. Most individuals with PSP pass away approximately seven years after symptoms begin, and frequently, the disease is only identified posthumously during an autopsy. Unlike Alzheimer’s, there are no tau scans, blood tests, or MRIs that can conclusively diagnose PSP, a fact that has hampered the development of treatments. Now, the discovery of a unique pattern of proteins in the spinal fluid of patients could lead to earlier diagnosis and the development of new treatments for PSP. In a study published in Neurology ...
Chemotherapy and similar treatments aimed at eliminating cancer cells often adversely affect patients’ immune cells. Each year, this results in tens of thousands of cancer patients suffering from weakened immune systems, making them susceptible to potentially fatal infections. Physicians are tasked with balancing the dosage of chemotherapy—enough to kill cancer cells but not so much as to dangerously reduce the patient’s white blood cell count, leading to neutropenia. This condition not only impacts health but can also lead to social isolation between chemotherapy sessions. Traditionally, monitoring of white blood cells has been limited to blood tests. Now, a new at-home white blood cell monitor offers doctors the ability to remotely monitor their patients’ health more comprehensively. This device, which avoids blood draws, uses light to scan the skin at the top of the fingernail and employs artificial intelligence (AI) to identify critically low levels of white blood cells. Based on ...
Lucy Therapeutics (LucyTx) has announced it has raised $12.5m in additional funding to develop potentially new drugs and advance the company’s research programmes for neurological diseases. The funding, provided by existing investors, Engine Ventures and Safar Partners, with recent participation from the Bill & Melinda Gates Foundation, the Michael J. Fox Foundation and £1.6m from Parkinson’s UK’s Biotech programme, brings the company’s total funding to $36m. The new project aims to develop novel therapies that are based on mitochondrial small-molecule treatments and diagnostic biomarkers for Alzheimer’s (AD) and Parkinson’s disease (PD), as well as continue the development of a novel drug target for Rett syndrome, a rare genetic neurological and developmental disorder that affects brain development. AD and PD are the two most common neurodegenerative diseases worldwide, affecting around 24 million and ten million people, respectively. Using LucyTx’s platform, the team will analyse a variety of disease drivers central to ...
Ahandful of UK charities and community pharmacists urged the UK government to find a fix for the ongoing drug shortage issue to prevent further patient suffering. The UK Epilepsy Society, SUDEP Action, Epilepsy Action and Parkinson’s UK, joined forces to call for a meeting with the Health Secretary, Victoria Atkins. The Association of Independent Multiple Pharmacies (AIMp) found that community pharmacists are spending an average of two hours every day to find patients’ medications due to the disruptions. In a 11 April press release, Dr. Leyla Hannbeck, AIMp’s CEO, said, “The system is overly complex and shrouded in secrecy – what we need is openness and transparency. Pharmacists are in the same position as patients – we are at the end of the supply chain but are the last people to find out about medication shortages. Consequently, we are unable to plan in advance and support the people who rely ...
Recently, Legend Biotech announced in Somerset, New Jersey, that the U.S. Food and Drug Administration (FDA) has approved CARVYKTI® (cilta-cel) for the treatment of relapsed or refractory multiple myeloid(RRMM) patients who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD), and are resistant to lenalidomide1. CARVYKTI® is the first and only B-cell maturation antigen (BCMA)-targeted therapy approved for second-line treatment of multiple myeloma patients, including CAR-T therapy, bispecific antibodies and antibody-drug conjugates (ADCs). The FDA’s approval is based on positive results from the CARTITUDE-4 study, which showed that compared with pomalidomide, bortezomib, and dexamethasone (PVd) or daratumumab, pomalidomide, and dexamethasone (PVd), DPd) these two standard treatment regimens, CARVYKTI® can significantly improve the progression-free survival (PFS) of adult patients with relapsed and lenalidomide-resistant multiple myeloma who have received first- to third-line treatment. This result has statistical and clinical significance. The approval ...
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