Latest news with #ShaheenLakhan
Medscape
4 days ago
- Health
- Medscape
Digital App Effective for Schizophrenia in Phase 3 Trial
CT-155 (Boehringer Ingelheim and Click Therapeutics), an investigational prescription digital therapeutic, was both safe and effective in reducing negative symptoms of schizophrenia in a new phase 3 trial, its manufacturers announced in a press release. Top-line results from the CONVOKE trial, which included 464 US adults with schizophrenia, showed that CT-155 plus standard-of-care antipsychotic therapy was associated with significantly reduced negative symptoms between baseline and week 16, meeting the study's primary endpoint. CT-155 was well tolerated and demonstrated a favorable safety profile similar to previous studies, the release said. 'The observed clinical benefit on experiential negative symptoms in this study, without additional known safety concerns, marks a critical advancement in understanding how we might address this long unmet need,' Shaheen Lakhan, MD, PhD, chief medical and scientific officer of Click Therapeutics, said in the release. Unmet Need Although available treatments have been used to help manage negative symptoms of schizophrenia, there is currently no approved treatment specifically for negative symptoms in the US, the companies noted. CT-155 was granted Breakthrough Device Designation by the FDA in 2024. So far, it is the only app designed solely for schizophrenia to have received this designation. Last year, the FDA approved the first new schizophrenia treatment in decades. But research reported earlier this year offered disappointing results from a phase 3 trial of that drug, xanomeline/trospium chloride (Cobenfy, Bristol Myers Squibb). As reported by Medscape Medical News , this has resulted in many clinicians becoming more open to exploring digital and technical solutions — including at this year's American Psychiatric Association (APA) annual meeting, where most research poster sessions featured presentations on apps targeting psychiatric conditions, including schizophrenia. CT-155 is a mobile app-based software designed to address negative symptoms of schizophrenia by providing interactive psychosocial techniques when used alongside standard pharmaceutical treatment. The app needs to be prescribed by a healthcare professional and is then installed onto smartphones. While the World Health Organization estimates that approximately 24 million people worldwide have schizophrenia, about 60% of them experience negative symptoms. These types of symptoms involve an absence or reduction of behaviors and functions considered normal, including blunted affect, reduced speech, and social withdrawal. Positive schizophrenia symptoms, on the other hand, are those that add experiences or perceptions, such as hallucinations, delusions, and paranoia. Detailed Results Coming Soon CONVOKE is a randomized, double-blind, multicenter, phase 3 trial. Its primary endpoint was reduction in experiential negative symptoms from baseline to week 16, as measured using the Clinical Assessment Interview for Negative Symptoms, Motivation, and Pleasure Scale (CAINS-MAP), for CT-155 vs a digital control app used along with standard-of-care antipsychotic therapy. Other endpoints, including change from baseline to week 8 on the CAINS-MAP and improvement on the Patient Global Impression of Improvement Scale at weeks 8 and 16 have not been released yet. However, detailed results from CONVOKE are scheduled to be presented in October at the European College of Neuropsychopharmacology Congress' Novel Therapeutics Symposium. Before today's results were announced, John Torous, MD, psychiatrist and director of Digital Psychiatry at Beth Israel Deaconess Medical Center in Boston, voiced his optimism about the study at the APA meeting and told Medscape Medical News he hoped the product could roll out quickly if it proved to be effective. After the results were released, he tweeted, 'Impressive results for a new app to support people with schizophrenia, given the study features a rigorous digital control group.' Torous added that he is 'excited to see such advances in digital health.'
Medscape
04-08-2025
- Health
- Medscape
Can Preventing, Treating Herpes Reduce Dementia Risk?
Mounting evidence points to a connection between dementia and common herpes virus infections, particularly herpes simplex virus type 1 (HSV-1), which causes cold sores, and varicella zoster virus (VZV), the cause of chickenpox and shingles. Multiple studies have shown that individuals with a history of these infections face a higher risk for dementia, including Alzheimer's disease (AD). What was once a fringe hypothesis has gained traction, as a growing body of research points to these viruses as major factors in Alzheimer's and other dementias. 'There is now quite a lot of evidence obtained by a variety of methods which suggests that this virus is really a major factor in Alzheimer's disease. And the weight of the evidence supports a causal role,' Ruth Itzhaki, MSc, PhD, visiting professor, The Oxford Institute of Population Aging, Oxford, England, told Medscape Medical News . Itzhaki was one of the first to hypothesize there was a potential connection between the herpes virus and AD and has spent much of her career investigating the link. These pathogens may act as 'under-recognized drivers of neurodegeneration. They can hide in the nervous system and reactivate later in life, each flare-up potentially inflicting cumulative damage that accelerates cognitive decline,' Shaheen Lakhan, MD, PhD, neurologist and researcher based in Miami told Medscape Medical News . One early clue came decades ago, when Itzhaki and colleagues discovered HSV-1 DNA in the brains of patients with AD, most notably in carriers of the apolipoprotein E epsilon 4 ( APOE ε4 ) gene, a known genetic risk factor for the disease. 'The virus and the gene may be working in tandem — a synergy where a latent viral infection 'flips the switch' on a genetic vulnerability,' Lakhan said. Supporting a potential causal role, Itzhaki's team has since demonstrated that HSV-1 infection of cultured human neuronal cells induces the accumulation of amyloid-beta and phosphorylated tau — the primary components of amyloid plaques and neurofibrillary tangles in AD. The treatment with antiviral agents significantly reduced both these pathological markers and cell death. Are All Herpes Viruses Tied to Dementia? While research strongly suggests a link between certain herpes viruses and an increased risk for dementia, not all herpes viruses have been implicated. HSV-1 and VZV have been more consistently linked to an increased risk for dementia, including AD. While some studies suggest a possible association with HSV-2 (genital herpes), the evidence is less conclusive than that for HSV-1 and VZV. Other herpes viruses, like cytomegalovirus, have not shown a strong or consistent association with an increased dementia risk in most studies. Research has also suggested that individuals with both HSV-1 and VZV infections may face an elevated, compounded risk. In one study, patients co-infected with HSV and VZV had a hazard ratio of 1.57 for developing dementia, whereas those with HSV-1 alone had a hazard ratio of 1.38 and those with VZV alone had a hazard ratio of 1.41. Itzhaki explained that multiple biologically plausible mechanisms — supported by various studies — may explain the link between herpes virus infections and an increased risk for dementia. For instance, herpes viruses can trigger chronic inflammation in the brain, a critical factor in neurodegeneration. Additionally, HSV-1 may promote amyloid plaque formation and influence tau phosphorylation, as previously noted. The damage and risk occur as a result of reactivation of dormant HSV-1 in the brain after various types of damage, Itzhaki noted. One recent study showed reactivation of dormant HSV-1 after mild brain injury or after cumulative general infections may drive neurodegenerative diseases by triggering pathological changes including accumulation of beta-amyloid and phosphorylated tau. 'The notion that a virus many of us carry could be stoking neurodegeneration is provocative, but the science behind it is becoming increasingly difficult to ignore. The past few years have delivered especially compelling data to support this viral link,' said Lakhan. Antivirals, Vaccines Preventive? Some studies suggest antiviral medications used to treat herpes infections and vaccination against VZV could potentially reduce the dementia risk. For example, one recent Taiwanese cohort study showed that symptomatic HSV-1 infection was associated with nearly a threefold increased risk of developing dementia. Antiherpetic medication reduced the risk by 90%. However, a study of US veterans showed no link between HSV infection and increased dementia risk. Nonetheless, similar to the Taiwanese study, antiherpetic medication was associated with a protective effect against dementia. Separately, in a matched case-control study of nearly 700,000 older adults, HSV-1 was more common in those with AD, and antiviral therapy for HSV-1 was associated with a lower risk of developing AD. Yet in the VALAD clinical trial, valacyclovir therapy did not change the course of disease in older adults with early AD or mild cognitive impairment and antibodies revealing previous herpes infections — mainly HSV-1. 'Our trial suggests antivirals that target herpes are not effective in treating early Alzheimer's and cannot be recommended to treat such patients with evidence of prior HSV infection,' lead investigator, Davangere P. Devanand, MD, professor of psychiatry and neurology and director of Geriatric Psychiatry, Vagelos College of Physicians and Surgeons, Columbia University, in New York City, said in a news release. 'We do not know if long-term antiviral medication treatment following herpes infection can prevent Alzheimer's because prospective controlled trials have not been conducted,' Devanand said. On the other hand, data suggest that vaccination against VZV may offer protection against cognitive decline. In a landmark UK study that leveraged a unique vaccine rollout policy in Wales and analyzed health records of over 280,000 older adults, the receipt of the live-attenuated shingles vaccine was associated with approximately a 20% reduction in the risk of developing dementia over 7 years. Lakhan said this study offers 'one of the strongest pieces of evidence yet that preventing varicella-zoster reactivation (shingles) may translate into protecting the brain. In an era when we have few effective dementia preventives, the possibility that something as simple as a vaccine or antiviral could reduce risk by 20% or more is galvanizing.' What to Tell Patients Lakhan believes 'the herpes-dementia connection can no longer be dismissed as coincidence; it demands our attention and further investigation.' He said physicians should be ready to address it in conversations with patients. 'It's increasingly common for older patients, and their families, to ask, 'Doc, I heard that cold sores or shingles might cause Alzheimer's — should I be worried?' Lakhan said. The answer should be 'balanced. We can't say herpes viruses cause Alzheimer's with absolute certainty, but we can say there's enough evidence to suggest they're contributing factors — and that taking steps to mitigate these infections is wise,' Lakhan said. He added that he now routinely recommends the shingles vaccine to all eligible patients not only to prevent a painful rash but also as a potential investment in their long-term brain health. 'There's little downside and plenty of upside to keeping these viruses at bay,' he added. He also advised 'prompt and aggressive' treatment of herpes outbreaks and prescribes antivirals for recurrent HSV-1 flares. Some researchers, he said, are investigating whether chronic suppressive antiviral therapy might help delay dementia in high-risk individuals, though it's too early to recommend this as standard practice. At present, Lakhan advises against prescribing daily antivirals solely for dementia prevention outside of clinical trials. However, for patients with frequent herpes reactivations or those who carry the APOE ε4 gene alongside a strong family history, he maintains a low threshold for treatment and emphasizes counseling on viral prevention. Itzhaki noted that several surveys suggest antivirals may offer some protection against dementia. Taking antivirals in late middle age — when the immune system weakens — could be considered for individuals infected with HSV who also carry genetic risk factors. Lakhan, said 'the bottom line for practitioners is clear — encourage shingles vaccination, stay vigilant against chronic herpes infections, and consider that maintaining viral suppression might become part of our toolkit for preserving brain health.'
Business Wire
22-04-2025
- Health
- Business Wire
Click Therapeutics Announces FDA Marketing Authorization for CT-132, the First Prescription Digital Therapeutic for the Preventive Treatment of Episodic Migraine in the United States
NEW YORK--(BUSINESS WIRE)--Click Therapeutics, Inc., ('Click') a leader in prescription medical treatments as both prescription digital therapeutics and software-enhanced drug™ therapies, has obtained FDA marketing authorization for the first prescription digital therapeutic for the preventive treatment of episodic migraine. FDA granted the De Novo Classification Request for the company's prescription digital therapeutic, CT-132, for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and/or other preventive treatments for migraine. The marketing authorization for CT-132 is based on data from the ReMMi-D (Re duction in M onthly Mi graine D ays, NCT05853900) study in patients taking standard-of-care prescription migraine medications (acute, preventive first-line, and preventive second-line), where CT-132 met its primary endpoint. Clinical results from the ReMMiD-C bridging study (NCT06004388), which showed that CT-132 performed similarly in patients taking calcitonin gene-related peptide (CGRP) inhibitors, were also submitted in the De Novo and included in the product's FDA premarket review. 'This marks a significant milestone for the more than 37 million adults in the US who live with migraine,' said Shaheen Lakhan, MD, PhD, FAAN, chief medical and scientific officer of Click Therapeutics. 'As a groundbreaking digital therapeutic for migraine prevention, CT-132 offers eligible patients a new path to reducing the burden caused by migraine, one they can access anywhere via an evidence-based mobile application on their smartphone, significantly improving accessibility and expanding care to patients.' Click Therapeutics recently presented CT-132 pivotal study results at the American Academy of Neurology Annual Meeting, where co-investigator Stewart J. Tepper, MD, Vice President of the New England Institute for Neurology and Headache and scientific advisor to Click shared in a post-conference Medscape article, 'I think this is very exciting as a clinician who takes care of patients because we don't have anything like this in our migraine armamentarium. We know that behavioral techniques are helpful adjunctively, but large areas of the country just don't have access to them.' 'With this landmark, first-in-class FDA authorization in episodic migraine, Click's interventions have now demonstrated clinically meaningful benefit across three unique therapeutic areas, including psychiatry, cardiometabolic disease and now neurology,' said David Benshoof Klein, chief executive officer of Click Therapeutics. 'As the first authorization in our neurology pipeline, and the first of our PDTs to target and successfully treat a pain-related condition, it confirms the power of Click's platform to deliver meaningful outcomes across therapeutic areas.' Built on Click's industry-leading AI-enabled platform, CT-132 combines scientifically proven therapies with proprietary mechanisms of action to deliver clinically-meaningful interventions for patients with episodic migraine. Click Therapeutics designs patient-centric applications like CT-132 by incorporating storytelling, user research, and elements of consumer technology to increase engagement and drive improved clinical outcomes, with the goal of delivering personalized treatment for effective migraine management. Intended for adjunctive use alongside other treatments for migraine, CT-132 demonstrated in clinical testing the ability to add clinically meaningful benefit on top of background pharmacotherapy. CT-132 is thus well-positioned for further development in the future as a software-enhanced drug™ therapy. Click's software-enhanced drug therapies combine software with pharmacotherapy to create software-enhanced drug™ treatment options, targeting the unique needs of a specific medication to deliver added clinical benefit to patients. Click launched its new product offering, Click SE™, in October 2024 to pioneer this new therapeutic category in response to increasing interest in the U.S. Food and Drug Administration (FDA) draft guidance on Prescription Drug-Use Related Software (PDURS). This marketing authorization announcement follows Click's recent Series C funding round news, announced in March 2025. Indication: The CT-132 prescription digital therapeutic is indicated for the preventive treatment of episodic migraine in patients 18 years of age and older. It is intended for adjunctive use alongside acute and / or other preventive treatments for migraine. Safety Information: There are no contraindications to using CT-132. CT-132 is not intended to be used as a standalone therapy. CT-132 does not replace or substitute other migraine treatments, including medication for migraine. Patients should continue their current treatment as directed. About the ReMMi-D Pivotal Study and ReMMiD-C Bridging study The indications for use for CT-132 are supported by the results from two double-blind decentralized randomized controlled trials, a pivotal study (ReMMi-D) and a bridging study (ReMMiD-C). The pivotal ReMMi-D study evaluated the effectiveness and safety of CT-132 for the prevention of episodic migraine in patients 18 years and older, compared to a sham digital control and included patients (n=558) on the most commonly prescribed migraine medications. ReMMiD-C was designed identically to ReMMi-D but required that participants (n=110) be taking at least one calcitonin gene-related peptide (CGRP) inhibitor, though participants were also permitted use of non–migraine-specific acute or preventive medications. The study designs mirrored those of contemporary randomized control trials for migraine drugs. However, unlike in drug studies, patients continued their existing migraine medications without any washout period, so the additive treatment effect of CT-132 on top of background pharmacotherapy could be evaluated. Both studies demonstrated that CT-132 reduced monthly migraine days (MMDs) compared to a sham digital control in patients already using acute and preventive migraine medications, with no device-related adverse events reported. At the completion of the pivotal ReMMi-D study, CT-132 demonstrated a statistically significant reduction in monthly migraine days (MMDs) after 12 weeks of treatment compared to the sham digital control (n=568, ITT population; treatment difference: –0.9 MMDs; p =0.005). Participants in the treatment arm experienced a mean reduction of –3.04 MMDs by the end of the intervention. Further, migraine related quality of life, assessed by the Migraine-Specific Quality-of-Life Questionnaire (MSQ, revealed a difference between the CT-132 and sham digital control arms from as early as 4 weeks and through weeks 8 and 12. Migraine disability, as measured by the Migraine Disability Assessment (MIDAS) score, improved more in the CT-132 arm than in the sham arm at the end of treatment. Note that the analysis of secondary effectiveness endpoints did not include multiplicity adjustment or formal hypothesis testing. Engagement and adherence were high and sustained over the full 12-week duration of the treatment, with a median of 81 daily lessons out of 84 completed by those receiving the sham digital control and a median of 84 completed by those receiving CT-132. CT-132 was well-tolerated, with no discontinuations due to treatment-emergent adverse events (TEAEs). The ReMMiD-C bridging study provided supportive information, also evaluated versus a sham digital control but without formal hypothesis testing, that demonstrated similar performance of CT-132 in patients taking the new-class of migraine-specific medications, CGRP inhibitors. About Migraine Migraine is a complex and debilitating condition that affects more than 37 million adults and is the second leading cause of disability in the United States. 1,2 It is characterized by episodes of moderate-to-severe headache and is generally associated with nausea and increased sensitivity to light and sound. 3 For those living with migraine, attacks unfold over hours to days and negatively impact key domains of life including employment, educational attainment, and relationships. 4 Despite the availability of preventive migraine medications, there remains a significant unmet need in migraine management. Many patients continue to experience frequent and debilitating attacks, even when using these drugs as prescribed. 5 About Prescription Digital Therapeutics Prescription Digital Therapeutics (PDTs) deliver evidence-based treatments directly to a patient via their smartphone in the form of a mobile app. With PDTs, the software is the treatment. PDTs are prescribed by a physician to treat a disease or condition, and as such are clinically validated and FDA-regulated. PDTs can be used independently or in combination with traditional pharmaceutical treatments. About Click Therapeutics Click Therapeutics, Inc. develops, validates, and commercializes software as prescription medical treatments for people with unmet medical needs. We are expanding the possibilities of medicine with Digital Therapeutics™ that combine clinical science with the power of software to create a new way to treat disease. Operating at the intersection of biology and technology, we use a proprietary platform-based approach to therapeutic development that leverages patient-centric design principles and innovative AI-based technologies to deliver a unique combination of engagement and clinical outcomes, consistently. Digital therapeutics on Click's platform are regulated, clinically validated prescription mobile applications that are being developed to address diverse areas of therapeutic need, including indications in psychiatry, neurology, oncology, immunology, and cardiometabolic diseases. In 2024, in response to FDA guidance on prescription drug use-related software (PDURS) and building off the capabilities of our platform, we launched Click SE™ to extend our digital therapeutics platform and expertise to the development of software-enhanced drug™ therapies that combine software with pharmacotherapy to offer added clinically meaningful benefit to patients. To date, three Click Therapeutics devices have received FDA marketing authorizations. The company's self-developed CT-132, a first-in-class prescription digital therapeutic for preventing episodic migraine, was granted De Novo classification by the FDA. Click Therapeutics, in collaboration with Otsuka, developed Rejoyn™, which became the first prescription digital therapeutic authorized by the FDA for the adjunctive treatment of major depressive disorder symptoms. Additionally, the company expanded its portfolio into cardiometabolic disease with AspyreRx, which received FDA marketing authorization for the treatment of type 2 diabetes. Our commitment to advancing digital medicine means we continually improve our platform technologies, ensuring we stay at the forefront of cognitive, behavioral, and neuromodulatory therapeutic innovation, to achieve the best possible outcomes for patients. Our diverse team of innovators—spanning clinicians, researchers, technologists, designers and more—works together to create cutting-edge digital therapeutics, united in the mission to transform patient care. For more information, visit and connect with us on LinkedIn. References
