clinical trials Archives - Medical Design Sourcing

Lantern Pharma aims to take drug to phase 3 for $100-200 million with AI-powered approach

Lantern Pharma’s AI-powered sprint

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Lantern Pharma (NASDAQ: LTRN), a publicly traded clinical-stage biotech company with a market cap of around $79 million as of mid-March 2024, is shooting for developing $200 million drugs with a machine learning-based platform.

The oncology-focused firm Lantern Pharma, profiled last year, has developed a new drug (LP-284) in less than three years for under $3 million, which CEO Panna Sharma notes is “unheard of.” By using AI, Sharma projects that the company could develop a drug from concept to phase 3 trials for a price tag of $100–200 million — a small fraction of the typically $2.3 billion drug development price tag.

“We’re developing new drugs in less than two and a half years, from an idea through GMP manufacturing, to orphan indications, and multiple publications at ASH [American Society of Hematology] and SOHO [Society of Hem…

Could LSD change the game in anxiety treatment?

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A once-controversial psychedelic substance could potentially be a promising treatment for generalized anxiety disorder (GAD). That’s the view of Dr. Rakesh Jain, a psychiatrist with extensive experience in clinical practice, research, and education, affiliated with Texas Tech University School of Medicine. Jain expressed optimism in LSD-based therapy while acknowledging the challenges inherent in such a radical shift, in a recent MindMed analyst briefing on the heels of its MM-120 winning a breakthrough designation for an LSD-based treatment for GAD, based on promising topline data from a phase 2b study.

A once-controversial psychedelic substance could hold the key to treating Generalized Anxiety Disorder (GAD). This is the view of Dr. Rakesh Jain, a prominent psychiatrist who serves as a clinical professor at the Department of Psychiatry at Texas Tech University School of Medicine. While ack…

FDA grants breakthrough status to LSD-based anxiety treatment

In a major shift away from decades of stigma, the FDA has granted Breakthrough Therapy Designation to MindMed‘s MM120, an LSD-based treatment for Generalized Anxiety Disorder (GAD). This milestone not only underscores the growing recognition of the therapeutic potential of psychedelics but also could point to a potential turning point for the struggling psychedelic sector and specifically bolsters the future of MindMed.

[Related: Could LSD change the game in anxiety treatment?]

Psychedelic stocks: A long, strange trip continues

As with many psychedelic companies, MindMed’s stock (NASDAQ: MNMD) has been on a rollercoaster ride in recent years, briefly reaching close to $60 per share in early and mid-2021 amid peaking investor enthusiasm for the potential of psychedelic-based treatments. But the stock, like many others in the sector, has faced significant declines as investor enthusiasm waned later in 2021 and 2022.

The breakthrough therapy des…

Debiopharm’s multilink technology and partnerships drive oncology pipeline strategy

Debiopharm, an independent Swiss biopharmaceutical company based in Lausanne, seeks to carve a niche in the competitive oncology and infectious disease markets. Its business model focuses on in-licensing promising drug candidates from universities and smaller biotechs, aiming to add value through development. (The company is also partnering with AI-focused firms like VeriSIM Life.) Sandra von Meier, its head of business development, highlights the company’s exploration of DNA damage response pathways, with Debio 0123, a Wee1 kinase inhibitor, as a notable Phase I asset. Debiopharm also emphasizes its proprietary Multilink linker technology for antibody-drug conjugates, a field with potential to improve therapeutic outcomes.

We’ve lightly edited the responses for brevity.

Can you provide a broad overview of Debiopharm and its drug discovery and development strategy?

Sandra von Meier

Sandra von Me…

Moving the needle on diversity in clinical trials: Where do we go from here?

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Enhancing patient diversity in clinical trials has become a key priority in drug development. The main concern is that critical data that includes underrepresented patient populations is being left out as many clinical trials do not reflect all populations that may eventually take a therapy. These underrepresented groups consist of women, including those who are pregnant and lactating, pediatric and elderly patients, people with disabilities, LGBTQ+ individuals, and racial/ethnic groups specifically, Black/African American, American Indian/Alaska Natives, Hispanics/Latinos, Asians, Native Hawaiian, and other Pacific Islanders.

As a result, the U.S. government has taken increased measures with the passage of the Food and Drug Omnibus Report Act of 2022 (FDORA), which will require sponsors to submit diversity plans to the U.S. Food and Drug Administration (FDA) for all late-stage st…

From gatekeeper to strategist: The evolution of the CISO role in drug development

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There’s an old joke about chief information security officers (CISOs) being gatekeepers of new technologies and initiatives – the infamous “Department of No.” Imagine a bouncer who, strangely, doesn’t let anyone in, saying the club is already too full, even when it’s clearly empty.

But that image is outdated — especially in risk-focused industries like financial services where CISOs are integral to digital transformation projects and the broader risk management considerations.

From CIS-‘no’ to risk maestro

“Drug development is a risk-focused industry as well,” said Daniel Ayala, chief security and trust officer for Dotmatics. “There is a huge amount of risk.” Consequently, CISOs working in pharma contexts are increasingly expanding their roles from technical experts to risk-aware business leaders who happen to have deep technical expert…

Rare diseases, immense needs: J&J’s mission to change the landscape

Rare diseases may seem niche, but their impact is far from small. An estimated 7,000 rare diseases exist, collectively affecting a staggering 300 million people worldwide. This immense burden of disease, coupled with a profound lack of treatment options, underscores the urgent need for innovation. “Actually, the total burden of disease and unmet medical need [for rare disease] is really high,” emphasizes Dr. Katie Abouzahr, vice president, autoantibody portfolio and maternal fetal disease area leader at Johnson and Johnson Innovative Medicine. In recognition of Rare Disease Day on February 29 in 2024, we spoke with Abouzahr to explore how Johnson & Johnson Innovative Medicine aims to tackle these challenges.

The profound scarcity of treatments for the thousands of known rare diseases drives Johnson & Johnson’s commitment to this area. Abouzahr highlights that many of these diseases still lack advanced therapies, emphasizing the “incred…

Eicos Sciences’ FDA-approved Aurlumyn promises to drastically reduce frostbite amputations

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Imagine scaling a mountain only to later lose digits or an entire hand to the unforgiving ravages of frostbite. For climbers, explorers, adventurous backcountry skiers, and even those caught in unexpected winter storms, severe cold exposure carries a devastating risk — amputation. Today, thanks to a potentially landmark FDA approval, the prospect of losing one’s extremities to frostbite becomes slightly less chilling.

Novel indication for iloprost

Eicos Sciences’s Aurlumyn, containing the active ingredient iloprost, offers a novel approach to treating severe frostbite. Iloprost, a synthetic version of a naturally occurring substance known as prostacyclin, targets two key problems. First, it addresses cold-induced blood vessel construction by widening them to restore essential blood flow to the affected tissues. Second, it prevents blood clots from forming, which can further block circulation…

When will drug development have its ChatGPT moment? Inside ambitious AI initiatives at Sanofi and Medable

In episode 4 of Ai Meets Life Sci, Kayleen Brown, managing editor at DeviceTalks and Brian Buntz, pharma and biotech editor, chat with Helen Merianos, Ph.D., head of R+D portfolio strategy at Sanofi and Michelle Longmire, MD, CEO of Medable. The focus? The two-fold application of AI in their respective companies’ technologies, both for scientific advancement and business productivity, were central themes. Sanofi is applying AI across the company, encouraging an inquisitive culture around product development. AI also aids in making more data-driven investments across various domains. Medable is tapping AI to build a culture of invention as decentralized clinical trials become more operationalized and scalable.

Tune in and subscribe to AI Meets Life Sci on all major podcast channels and follow youtube.com/@DeviceTalks or AI Meets Life Sci YouTube Podcast to ensure you never miss an episode.

Sanofi embraces AI for improved decision-making

In a June 2023 press rele…

Beyond diabetes and obesity: Can GLP-1 therapies also transform chronic disease treatment?

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Glucagon-like peptide-1 (GLP-1) receptor agonists like semaglutide and tirzepatide have cemented their status as two of the most successful drugs in recent memory. Recent projections have estimated that the drug class could fetch $44 billion by 2030 and $71 billion by 2032.

But GLP-1 sales could potentially reach greater heights as these therapies move beyond their established territories of diabetes and obesity and start tackling major conditions like chronic liver and kidney disease, Alzheimer’s disease, and heart failure.

Promising clinical trial results highlight the potential of GLP-1s in an array of disease, including chronic kidney disease, nonalcoholic steatohepatitis (NASH), various forms of heart failure and potentially even Alzheimer’s.

There are, however, hurdles, such as a relatively high rate of gastrointestinal (GI) side effects, which affect somewhere around 40–7…

Off with the training wheels: AI-based patient characterization can improve clinical trial performance without large data sets

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Only 12% of new drug candidates that enter phase 1 clinical development ultimately receive FDA approval. This dismal success rate leaves millions of patients with unmet medical needs and drives up the costs for the small number of drugs that make it to market. More frustratingly, it leaves untold numbers of potentially transformative therapies back-burnered or discarded entirely, not because they don’t actually provide benefit, but because they were tested in trials that weren’t effectively designed to demonstrate benefit. The true failure hasn’t been in drug innovation but in identifying the patient traits that govern clinical trial outcomes.

The big challenges of big data methodologies

Artificial intelligence (AI) holds great promise in improving this success rate by providing data-driven approaches to identifying traits and their combinations that enable more effective paradigms to enrich patien…

Bridging the gap: How resource sheets translate complex clinical trial data into patient empowerment

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As patients take a more active role in managing their health, they can find navigating the complexities of clinical trial results daunting. Having access to clear, accurate information is crucial for informed decision-making. This is where patient-reported data from clinical trials has real value, offering key insights into the real world experiences of participants, both positive and negative. To bridge the gap, patient-centered resource sheets, developed through collaborative efforts between researchers and patients, provide a valuable information source that translates clinical information into easy-to-understand language and is presented with sensitivity and empathy. More than just presenting data, these resources explain and contextualize it for individual patients, bridging the gap between research and their specific needs. The result? Patients feel confident enough to make informed choices that ult…