Yazılar

Drugmakers Turn to AI to Speed Trials and Submissions

/in /tarafından

Pharmaceutical companies are increasingly using artificial intelligence to accelerate clinical trials and regulatory submissions, even as AI has yet to deliver major breakthroughs in discovering new drugs. Industry executives say the technology is already saving weeks by automating participant recruitment, site selection, and the preparation of vast regulatory documentation.

Executives from major drugmakers including Eli Lilly, AstraZeneca, Roche, and Pfizer said at the JP Morgan Healthcare Conference that AI tools are helping manage thousands of pages of clinical, safety, and manufacturing records required by regulators worldwide.

Drug development can take more than a decade and cost around $2 billion. Companies are betting that AI can improve efficiency and success rates by handling what executives call the “messy middle” of development. Consultancy McKinsey estimates that autonomous, or agentic, AI could lift clinical development productivity by up to 45% over the next five years.

Israeli drugmaker Teva Pharmaceutical Industries said it is using AI to streamline processes so researchers can focus on bringing new medicines to market. Meanwhile, Novartis used AI to cut site selection for a large cardiovascular trial from weeks to hours, helping it hit enrollment targets with minimal overshoot.

Other companies are also reporting tangible savings. GSK said digital and AI tools helped reduce late-stage trial costs by millions of pounds, while Denmark’s Genmab plans to deploy AI agents to automate post-trial analysis and reporting.

While investors are still waiting for the first fully AI-designed blockbuster drug, executives say the technology is already reshaping how trials are run and how data is submitted. Amgen’s research chief said many AI-designed molecules are already moving through pipelines, suggesting the biggest impact may still lie ahead.

EU Regulator Approves AI Tool for Fatty Liver Disease Trials

/in /tarafından

The European Medicines Agency (EMA) has approved the use of an artificial intelligence (AI) tool, AIM-NASH, to assess the severity of metabolic dysfunction-associated steatohepatitis (MASH) in clinical trials. The condition, which affects 1.5% to 6.5% of U.S. adults, is a challenging liver disease with limited treatment options.

AIM-NASH utilizes machine learning trained on over 100,000 annotations from 59 pathologists who analyzed more than 5,000 liver biopsies across nine major clinical trials. The EMA’s human medicines committee (CHMP) found that the AI tool provides more consistent and reliable assessments than traditional methods, which rely on subjective evaluations from multiple pathologists.

With this approval, data generated using AIM-NASH will be considered scientifically valid in clinical trials, potentially accelerating the development of new MASH treatments. Currently, Madrigal Pharmaceuticals’ Rezdiffra is the only U.S.-approved drug for MASH, while companies like Novo Nordisk and Eli Lilly are conducting trials to explore additional treatment options.

Zealand Pharma Heralds Obesity Drug Alternative: “Our Crown Jewel” Amid Fierce Competition

/in /tarafından

Zealand Pharma, a Danish biotech company, is aiming to revolutionize the obesity treatment market with what it calls the “next generation” of weight loss drugs. Competing against major players like Novo Nordisk and Eli Lilly, Zealand Pharma’s CEO, Adam Steensberg, expressed optimism about the company’s experimental drugs that could set new standards for weight management, particularly with its amylin analog candidate, Petrelintide. Steensberg referred to Petrelintide as their “crown jewel,” positioning it as an alternative to the increasingly popular GLP-1 treatments, such as Novo Nordisk’s Wegovy and Eli Lilly’s Zepbound.

The Promise of Petrelintide and Dapiglutide

While Zealand Pharma has already reported positive results from early-stage trials of Dapiglutide, a GLP-1/GLP-2 receptor dual agonist, the company’s real focus is on Petrelintide, which offers a novel approach by mimicking the hormone amylin. Amylin, co-secreted with insulin, helps regulate feelings of fullness (satiety), a mechanism different from GLP-1 treatments that suppress appetite by mimicking gut hormones. This differentiation is key, as Petrelintide aims to offer significant weight loss with fewer side effects and reduced muscle loss—common concerns associated with current GLP-1 treatments.

According to Steensberg, the goal is to offer patients a more “pleasant experience” with long-term treatment possibilities. Amylin analogs like Petrelintide are emerging as a new category in obesity treatment, with the potential to become a foundational therapy in the coming years.

Strong Early Results and Growing Competition

In June 2024, Zealand Pharma announced promising results from a phase 1b trial of Petrelintide, which demonstrated an average body weight reduction of up to 8.6% over a 16-week course. The company believes this robust data supports Petrelintide as a viable alternative to GLP-1 treatments, particularly for those who struggle with their side effects.

Novo Nordisk, which currently dominates the obesity market, is also working on its own amylin-based therapy by combining semaglutide (the active ingredient in Wegovy) with amylin analog Cagrilintide in a candidate drug called CagriSema. This further highlights the growing interest in amylin-based therapies within the competitive obesity treatment landscape.

Zealand Pharma’s smaller size presents a challenge in competing with the pharmaceutical giants. Emily Field, head of European pharmaceuticals research at Barclays, noted that while Zealand Pharma’s developments are promising, the company will likely need a larger pharmaceutical partner to scale its operations effectively.

Searching for a Global Pharma Partner

Zealand Pharma, which has seen its share price more than double this year due to excitement around its obesity drugs, is now actively seeking a global pharmaceutical partner to help bring its treatments to market. Steensberg acknowledged that despite the company’s recent $1 billion capital raise, partnership is essential for the next phase of development, particularly as both Petrelintide and Dapiglutide move into phase 2 trials in 2024 and 2025.

With rising competition, including established players like Novo Nordisk and Eli Lilly and an estimated $200 billion market by 2030, partnering with a global firm would provide Zealand Pharma with the resources necessary to scale production and marketing efforts.

Future of Obesity Treatment and Market Fragmentation

The obesity drug market is expected to become increasingly fragmented as different pharmaceutical companies target specific segments and patient needs. Analysts believe that focusing on niche areas, such as treatments that reduce muscle loss, will help smaller companies like Zealand Pharma carve out space alongside the market leaders. As demand for these treatments continues to surge globally, companies are racing to create the next big breakthrough in weight management.

Zealand Pharma’s strategic focus on amylin analogs, coupled with its search for a strong pharmaceutical partner, positions the company to make a significant impact in the coming years. Steensberg remains optimistic, viewing their developments as “an attractive opportunity” for potential partners and asserting that amylin analogs could become a first-line therapy in the near future.

Conclusion

Zealand Pharma’s innovative obesity drug candidates, particularly Petrelintide, hold great promise in reshaping the future of weight management treatments. As the company advances its clinical trials and seeks a global pharmaceutical partner, it faces both opportunities and challenges in an increasingly competitive and lucrative market. With the growing demand for effective and tolerable weight loss solutions, Zealand Pharma’s next-generation treatments may very well play a pivotal role in the future of obesity care.