drug development Archives - Medical Design Sourcing

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 …

How Lantern Pharma and Code Ocean partnered on oncology drug development

A vision for data-driven drug development in oncology

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When Peter Carr, principal software architect of Lantern Pharma, stepped into his full-time role in September 2020, the company was on the cusp of a transformation. While AI had been a focus for a number of years, a fresh infusion of cash provided a possibility of expanding its AI capabilities and machine learning capabilities to drive down the cost of drug development in oncology.

Founded in 2012, the company went public in June 2020, raising $26 million. By the time he officially joined, Carr was already familiar with its operations, having previously worked as a consultant in 2019 to help set up the infrastructure. Carr joined full-time to help the company “expand their use of AI and machine learning for target discovery and patient stratification,” he recalled.

The challenge: Siloed research

While the company had experience in using A…

How the latest AI executive order might impact drug development in the U.S.

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The White House has released an executive order that contains what it hails as “the most sweeping actions ever taken to protect Americans from the potential risks of AI systems.” Relevant to drug development, a fact sheet on the order describes its aim to help further “the responsible use of AI in healthcare and the development of affordable and life-saving drugs.” The order also is designed to protect against the risks of using AI to synthesize new chemicals and biological materials, and will require government agencies funding life science projects to follow these standards as a prerequisite.

Other provisions of the order that could affect drug developers include its potential to affect AI-assisted clinical trials. The order could require drug developers to ensure that their algorithms do not exacerbate discrimination in clinical trials or patient interactions. Drug …

Guselkumab shows durable benefits in Crohn’s disease in LTE of phase 2 study

The interleukin-23 blocker guselkumab (Tremfya) continues to show promise in treating Crohn’s disease (CD). First winning FDA approval for plaque psoriasis in 2017, guselkumab recently demonstrated robust efficacy and a consistent safety profile in the long-term extension of the GALAXI Phase 2 study for CD.

Some 54.1% of patients receiving guselkumab achieved clinical remission by the three-year mark, compared to 46.0% for those treated with Stelara (ustekinumab), the company’s interleukin-12 and -23 antagonist that won FDA approval for CD in 2016. Patient-reported outcomes were also promising in the GALAXI trial, with 51.4% of guselkumab-treated patients achieving PRO-2 remission, a patient-reported outcome measurement used in inflammatory bowel disease (IBD) studies, compared to 39.7% for ustekinumab. From an endoscopic perspective, 34.7% of patients on guselkumab showcased a positive response, compared with 19.4% on ustekinumab.

An overview of GALAXI LTE …

Alzheimer’s at an inflection point as drug and diagnostics breakthroughs emerge

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Alzheimer’s disease research appears to be hitting its stride, thanks to recent therapeutic advances in drug development and the emergence of biomarkers to detect the condition. “All the pieces of the puzzle of precision medicine, which is already quite common in oncology, are now in place,” said Hartmuth Kolb, vice president, neuroscience biomarkers and R&D global imaging at Johnson & Johnson Innovative Medicine.

There’s urgency to stem the tide of the disease, which not only can be heart-wrenching for patients and caregivers, but also its financial burden. The cost of caring for individuals living with Alzheimer’s or other dementias in the U.S. could hit $345 billion in 2023, according to the Alzheimer’s Association, marking a $24 billion increase over the prior year.

Aiming to stop the cascade

FDA has approved two amyloid-targeting antibodies, lecanemab and …

Moving beyond pilot purgatory: Scaling AI in drug discovery projects

3D representation of the HTLV-1 intasome (a type of nucleoprotein complex) structure as visualized through cryo-electron microscopy. [Adobe Stock]

The topic of AI in drug discovery and development may continue to garner significant attention, but harnessing AI effectively requires a nuanced strategy, and an ability to navigate between details and the bigger picture.

Andrew Anderson, vice president of innovation and informatics strategy at ACD/Labs, likens it to boiling water. “On a small scale, it’s straightforward. But boiling a tanker cart full of water? That’s a different ballgame,” he said.

Thinking through these aspects is vital to address the ‘pilot-purgatory’ problem, which frequently arises in projects involving emerging technology. As a growing number of drug developers launch proof-of-concept AI projects, a significant number are struggling to scale them. “There’s a stru…

Johnson & Johnson pharma rebrand highlights innovation as a pillar to reinforce trust

Global pharma and medical device giant Johnson & Johnson (J&J) has ditched its iconic cursive logo that dates back to the late 19th century, and rebranded its Janssen pharma division as Johnson & Johnson Innovative Medicine. The move underscores the company’s push to prioritize higher-margin prescription drugs. This strategic move comes amidst a backdrop of significant legal challenges the company has faced in recent years.

In the five-year period from 2018 to 2022, Johnson & Johnson was the most active defendant in medical device and pharmaceutical cases. In addition, before spinning off its consumer health division, the company was targeted in tens of thousands of lawsuits alleging J&J-branded talcum powder causes cancer. Earlier this year, a judge dismissed the company’s attempt to settle thousands of lawsuits through bankruptcy.

The chart below shows the number of cases filed against J&J-affiliated entities in the life sciences secto…

Gate Neurosciences takes on depression with event-driven pharmacology

From left to right: the NMDA and AMPA receptors transport calcium cations into neurons after being activated by the neurotransmitter glutamate and the GABA receptor (right) transport chloride anions after the activation by gamma aminobutyrate. [Adobe Stock]

Much of the world is grappling with a mental health crisis — with soaring rates of depression and anxiety. Last year, the startup Gate Neurosciences emerged with a novel approach. While the Carmel, Indiana–based company is focused on synaptic plasticity like many other contemporary CNS companies, it diverges in its strategy. Rather than using a traditional occupancy-based model, which intends to achieve therapeutic effects by ensuring the continued presence of the drug in the body and binding at target receptors, the company’s aim is to ensure that effects persist even after a drug is no longer biochemically active in the body

Gate’s approach to even…

How synthetic data accelerates oncology research and drug development

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Synthetic data in oncology is transforming how researchers and developers approach real-world evidence. They often need this evidence to test hypotheses, predict outcomes and develop algorithms. But privacy constraints and access related to patient data can create delays and lengthen project timelines.

Oncology drug researchers and developers have recently begun using synthetic data in oncology to get around the privacy constraints and access issues related to patient data that create delays and lengthen project timelines.

Conceptually, synthetic data in oncology is about taking private patient information and enabling researchers to access the data without compromising privacy, offering a significant tool for current oncology research processes.

Traditional vs. new data approaches in oncology research

Traditionally, oncology researchers and drug developers have relied on t…

A year in review: AI’s evolving role in drug discovery and development in 2023

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In the realm drug discovery, AI is making waves, and 2023 could potentially be a pivotal year for this technology. As the technology enters the popular consciousness, pharma employees are wondering “why they can’t have similar AI-driven tools for their professional tasks,” said Diane Wuest, head of digital R&D at Sanofi, in a recent interview.

Still, some executives at pharma companies worry about AI’s potential to generate misleading data, as the Economist notes. Such fears are not entirely unfounded. While most headlines continue to tout AI’s promise in the field, there was a notable failure in 2023: an AI-aided drug failed a pair of phase 3 trials.

This article provides an overview of AI’s increasing traction in drug discovery and development in 2023 from January to early August. We’ll update it as the year progresses.

Janua…

New HHS initiatives put spotlight on long COVID

The U.S. Department of Health and Human Services (HHS) recently announced two major initiatives to shed light on long COVID, a condition affecting millions. First, the agency plans to establish the Office of Long COVID Research and Practice. HHS is also set to launch new long COVID-19 clinical trials through its RECOVER initiative. Jointly, the long COVID drug development efforts highlight the need for therapies and create openings for pharmaceutical companies to drive research and drug development related to the condition.

HHS has earmarked $1.15 billion for the RECOVER Initiative to explore novel therapies for the condition estimated to have affected between 7.7 and 23 million Americans. To date, the RECOVER Initiative has enrolled more than 24,000 participants in observational studies on long COVID. New clinical trials, beginning enrollment in summer 2023, will test experimental therapies across five focus areas to identify therapies that can alleviate symptoms and…

Sanofi puts AI ‘Plai’ app at the center of drug discovery and clinical trial operations

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The French pharmaceutical giant Sanofi has unveiled a new AI-powered app called Plai, developed in partnership with AI platform Aily Labs. This move is part of Sanofi’s plan to become the pioneer in fully integrating AI into all operations, according to CEO Paul Hudson.

Plai, designed to compile and process Sanofi’s internal data from various departments, creates bespoke “what if” scenarios to guide decision-making. Sanofi aims to exploit Plai’s analytical capabilities to enhance strategic planning.

From ChatGPT and Google Maps to Plai

Sanofi’s AI aspirations are longstanding. In 2022, the company launched its inaugural digital accelerator, supporting the adoption of digital, data and AI across operations. That same year, Sanofi acquired Amunix Pharmaceuticals, tapping its AI technology to develop targeted cancer therapies that spare healthy tissue.…