clinical trials Archives - Page 2 of 11

A timeline of Aduhelm’s rise and fall

The story of Aduhelm has been rocky now for years. Biogen turned heads when its controversial Alzheimer’s therapy won accelerated approval from the FDA against the advice of its own advisory panel in mid-2021. The company had high hopes for the antibody at that point, pricing it at an average of $56,000 per year. Aduhelm would encounter a series of blows after that – rejected coverage, dismal sales, discontinued trials. Biogen would ultimately pull the plug on the drug this year.

Now, Biogen aims to prioritize other Alzheimer’s programs like the lecanemab, which was jointly developed with Eisai and FDA-approved in July 2023. Biogen noted in a statement that insights gained from Aduhelm hold value for the company. Ultimately, Biogen recorded a $60 million charge tied to wrapping up Aduhelm’s development.

A timeline showing the ups and downs in Aduhelm’s journey in reverse-chronological order follows. Stock data are from Yfinance and annotation chart …

Inside Amgen’s ATOMIC strategy to use ML to accelerate clinical trials

[Image credit: Amgen]

Amgen has developed a machine learning platform to slash clinical trial times through smarter site selection. Known as ATOMIC, short for Analytical Trial Optimization Module, the system crunches disparate datasets to predict optimal trial locations, expedite enrollment and trial processes. Early results indicate more than a two times increase in enrollment speed at ATOMIC sites.

ML-powered clinical trial oracle could compress clinical trial cycle time

“With the massive amounts of data we’re pulling from various sources, we anticipate that by 2030, we’ll be able to shave about two years off the development times for our drugs,” said Sheryl Jacobs, vice president, global Development operations at Amgen. For now, the company is steadily ramping up the number of trials using the ATOMIC process. “Within the next year or two, we expect the majority of our trials will be using the AI …

Rice Biotech Launch Pad plans to make Houston a top-tier biotech hub

Rice Biotech Launch Pad: A collaboration hub at TMC’s Helix Park. [Image courtesy of TMC Helix Park | Texas Medical Center]

Houston boasts many world-class assets that have made it a formidable player on the global stage. From the world’s largest medical complex to mission control for the cosmos, few other cities can compete with its diverse strengths. Houston is also home to the prestigious Rice University, renowned for its leading science and engineering programs.

Houston, the nation’s fourth largest city, has not traditionally been a leader in biotechnology, but Rice University’s new Rice Biotech Launch Pad aims to change that. As Omid Veiseh, director of the Launch Pad, explains, “What we wanted with the Launch Pad was something different.” The goal is to capitalize on Rice’s research strengths and the vast medical expertise at the nearby Texas Medical Center.

Ho…

Medable: AI-powered platform can halve trial build times

Decentralized clinical trial pioneer Medable unveiled an intelligent automation technology at the JP Morgan Health Care Conference, claiming it can slash standard trial build timelines by at least 50%. This development hinges around electronic clinical outcomes assessment (eCOA) — a common bottleneck in trial startups.

“We’ve used AI to essentially take a protocol and translate that into a mobile application that is running on a patient’s phone,” said Dr. Michelle Longmire, CEO of the company in a recent interview. “The app can partner with patients in their health journey, asking them the right questions at the right times to understand how they’re doing with their clinical trial intervention.”

The AI in question involves the use of large language models for complex task automation and workflow orchestrations.

Medable notes that prominent Big Pharma companies are using the automation technology to cut weeks off build times. “AI has sol…

Using AI to unlock new uses for existing cancer medicines

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Repurposing is a drug development strategy that has been widely applied in cancer. This strategy, sometimes called label expansion, involves obtaining FDA approval to market a drug for the treatment of new indications, alone or in combination with other drugs. Not only can this approach extend the window of patent protection for a commercialized drug, but the path to regulatory approval can also be far less costly and risky than the traditional approach to drug development, largely because clinical evidence of safety already exists. And most importantly, the result is more and better treatment options for patients.

In keeping the law of unintended consequences, recent provisions introduced by the 2022 Inflation Reduction Act (IRA) blunted the potential benefits of drug repurposing. As a result of limiting the window of time during which pharmaceutical companies can recoup investments before…

Insilico Medicine’s latest AI-engineered drug ISM5411 could provide a novel approach for treating IBD

Alex Zhavoronkov, Ph.D.

Capping off a busy 2023, Insilico Medicine has announced a potentially first-in-class oral PHD inhibitor for the treatment of inflammatory bowel disease (IBD). ISM5411 is the fifth AI-backed drug candidate from Insilico Medicine to reach clinical stages.

ISM5411 targets prolyl hydroxylase domain (PHD) enzymes via modulation of the hypoxia-inducible factor (HIF) pathway, which is involved in cellular response to low oxygen levels. By inhibiting PHD, ISM5411 aims to stabilize HIF, thereby enhancing the expression of genes that help protect the gut lining and reduce inflammation.

AI’s role in ISM5411’s development

To develop ISM5411, InSilico tapped its AI platform, Pharma.AI. This involved deploying Chemistry42, a generative AI engine, which created the structure-based small molecule based on the PHD target protein structure. “After obtaining a series of lead compound…

Genmab’s data-driven strategies speed up drug commercialization

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Genmab’s senior vice president, global head of data science and AI, Hisham Hamadeh, describes the company’s journey to becoming “a data-driven decision-making company.” In one sense, there is little choice but to do so. “We’re swimming in data like never before. We’ve seen the volumes of data, the ability to compute on that data, and the type of algorithms that are emerging,” he said.

The initiative has the firm support of the company’s CEO Jan G. J. van de Winkel, who expects AI to help enhance R&D efficiency in the coming years. Already, the company has succeeded in winning FDA approval for the antibody epcoritamab in lymphoma within five years after the first patient was dosed. The approval timeline was “a world record,” van de Winkel told Medwatch, adding that the company believes its investments in data science will unlock further breakthrou…

Nipocalimab shows promise in RA subgroups in phase 2a IRIS-RA study

Johnson & Johnson’s nipocalimab, which works by targeting the neonatal Fc receptor (FcRn), has the potential to treat an array of autoimmune conditions. But the antibody recently hit a snag in the first-ever clinical study of an FcRn inhibitor in rheumatoid arthritis (RA), missing its primary endpoint. The development has sparked debate within the rheumatology community. “Now, there are some highly respected physicians who’ve said, ‘This is a failed trial,’” said Dr. Peter Taylor, the Norman Collisson Professor of Musculoskeletal Sciences at the University of Oxford. “I think that’s an incorrect interpretation.”

Johnson & Johnson is also pursuing a host of other autoimmune indications for nipocalimab. The FDA has granted it Fast Track designation for hemolytic disease of the fetus and newborn (HDFN) and orphan drug status for HDFN while EMA granted it orphan medicinal product designation for HDFN.

Breaking down the data from IRIS-RA

Johnson …

Cybin sees near future for psychedelic therapy after promising interim phase 2 data

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With promising interim phase 2 data in hand, Cybin believes psychedelic therapy will become a reality in the “not too distant future,” according to CEO Doug Drysdale.

As recently as the 1990s, it would be difficult to imagine that a psychedelic drug would potentially be a clinical option for a mood disorder like depression. But before long, data from multiple phase 3 trials will be available on psilocybin derivatives for various mood disorders.

Interim phase 2 CYB003 data as a ray of hope for treating mood disorders

Toronto, Canada–based Cybin recently unveiled upbeat interim phase 2 data related to CYB003, a proprietary deuterated psilocybin analog, in patients with moderate to severe major depressive disorder (MDD). In the randomized double-blind placebo-controlled study, CYB003 demonstrated a rapid and robust reduction in depression symptoms just three weeks …

The future of MDD treatment: A comparative table highlighting the emergence of fast-acting therapies

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The treatment landscape for major depressive disorder (MDD) continues to diversify, and in the coming years, psychedelic options may be available, including COMPASS Pathways COMP360 and the deuterated psilocybin analog CYB003 from Cybin. CYB003 demonstrated a significant -14.08 point reduction in MADRS score, a 53.3% response rate, and a 20% remission rate at a 12mg dose in interim results from its phase 2 study.

The potential of faster-acting more effective therapies

While it is difficult to compare the results from disparate clinical trials, some broad patterns emerge when viewing data from current treatment options and drugs now in clinical development for MDD (see table below). In contrast, newer treatment options, especially psychedelic therapies such as CYB003 and COMP360, demonstrate potentially faster onset and greater magnitude of symptom reduction.

The promise of NMDA and dopamine rec…

How a data lakehouse can give you a panoramic view of your AI-enabled clinical trials

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In recent years, the term “data lakehouse” has entered the lexicon of data professionals. For AI-enabled clinical trials, the lakehouse architecture promises seamless integration of diverse data streams, spanning patient health records to real-time sensor data, all processed efficiently and queried in structured formats.

The lakehouse architecture aims to provide a comprehensive overview of data, ensuring both vast storage and real-time processing capabilities. In other words, the lakehouse offers the “best of both worlds” when it comes to data warehouses and data lakes, according to Venu Mallarapu, vice president of global strategy and operations at eClinical Solutions.

AI and ML move from buzzwords to practical tools in clinical trial management

As the use of AI and ML in clinical trials becomes more prevalent in patient recruitment, real-time data monitoring and beyond, …

NLP in drug discovery and the quest for the ‘right’ research elements

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In drug discovery and development, data sources are as diverse as they are plentiful. There are comprehensive databases brimming with molecular targets, cellular processes, genomic sequences, proteomic profiles, and metabolite patterns that shed light on disease pathways. Data possibilities in the patient care realm are similarly vast, spanning electronic medical records, imaging datasets, and even patient-reported outcomes and adverse events reported on social media. The biomedical research site PubMed has tens of millions of research articles and studies.

Yet, it’s easier to drown in such turbulent data volumes than it is to swim. Various estimates over the past decade have projected that 80% of healthcare data are unstructured. “There’s a huge amount of information that’s not standardized,” said Jane Reed, director of life sciences with Linguamatics, an IQVIA company.…