Ascletis Achieves Milestone in Groundbreaking Glioblastoma Trial – 120 Patients Enrolled for Phase III Study of ASC40 FASN Inhibitor Combined with Bevacizumab

Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) marks a remarkable milestone today as they proudly announce the culmination of patient enrollment in their Phase III registration clinical trial. This groundbreaking trial harnesses the potential of ASC40 in tandem with bevacizumab to combat the relentless adversary known as recurrent glioblastoma (rGBM).

ASC40, an oral wonder, stands as a selective small molecule inhibitor, taking on the role of a guardian against fatty acid synthase (FASN), a pivotal enzyme orchestrating the symphony of de novo lipogenesis (DNL).

With ASC40’s disruptive prowess, it doesn’t just inhibit energy supply; it orchestrates a symphony of change, altering the very composition of tumor cell membranes. In a world battling glioblastoma, ASC40 emerges as a beacon of hope [1].

In the heart of an epic battle against recurrent glioblastoma (rGBM), the Phase III registration clinical trial ( Identifier: NCT05118776) is a beacon of hope. Picture this: a grand stage, where science meets destiny. It’s a randomized, double-blind, and placebo-controlled spectacle unfolding across multiple centers in China. What’s at stake? Nothing less than the progression-free survival (PFS), the ultimate survival (OS), and the safety of rGBM patients.

Here’s the plot twist: 180 brave souls, each facing their own unique chapter in this story, will be cast into two cohorts. Cohort 1, equipped with the potent oral ASC40 tablet (taken once daily) alongside Bevacizumab. And then, there’s Cohort 2, where a matching placebo tablet (also once daily) joins forces with Bevacizumab.

But hold on, there’s more. An intriguing twist awaits! At a crucial juncture, when the story hangs in the balance, an interim analysis comes into play. After 93 PFS events have woven their narrative, the analysts step onto the stage. It’s a moment of reckoning, a turning point in the tale, where science and fate converge to unveil the promise of progress.

In the realm of brain tumors, Glioblastoma (GBM) reigns as the unrivaled monarch of aggression, a true grade IV glioma according to the revered World Health Organization (WHO). Picture it as the thunderstorm among clouds, for GBM accounts for a commanding 57% of gliomas, casting a long shadow over the landscape of neurological health in China. Here, its annual incidence, a chilling 2.85 to 4.56 cases per 100,000 population, whispers the tale of 40,000 to 64,000 new GBM warriors each year [3].

Now, across the vast seas in the United States, GBM wears its crown with equal authority, constituting a formidable 56.6% of all gliomas. Its incidence rate, at 3.21 per 100,000, paints the portrait of an adversary that doesn’t discriminate by borders or boundaries [4].

But here’s the heart-wrenching truth: even in the face of fierce battles waged through surgery, radiation, and chemotherapy, over 90% of GBM’s victims experience a cruel resurgence. Hope is a rare gem in this landscape, where effective treatments for those facing recurrent GBM are as elusive as the finest stardust.

In the intricate dance of cancer, lipid metabolism has emerged as a star performer, a revelation that has ignited the imaginations of researchers worldwide [1]. Dr. Jinzi J. Wu, the visionary Founder, Chairman, and CEO of Ascletis, recognizes the pivotal role played by FASN in this metabolic symphony, casting it as a tantalizing prospect for clinical exploration.

Now, picture this: A grand stage is set, illuminated by the glow of hope and scientific curiosity. Here, in the spotlight, 120 patients have taken their places, each carrying a unique thread of the story, in the Phase III clinical trial of the remarkable FASN inhibitor, ASC40. This moment, this gathering of brave souls, signifies more than just numbers; it’s a milestone etched in the heart of the Phase III study, a chapter with pages yet unturned.

As Dr. Wu’s words resonate, there’s a collective anticipation, a shared breath held in the name of discovery. With this rich ensemble of patients, events are unfolding that promise to illuminate the path ahead. The interim analysis of progression-free survival (PFS) looms on the horizon, a pivotal moment where science and hope converge. The world watches, as the stage is set for the unveiling of results that may just rewrite the story of glioblastoma treatment.

In the world of cancer research, it’s like discovering hidden treasure – the profound impact of lipid metabolism [1]. Think of it as a journey through the corridors of the brain, where the 2016 World Health Organization classification of central nervous system tumors serves as our guide, shedding light on the intricate tapestry of these mysterious afflictions [2].

Now, let’s travel to the vibrant heart of China, where the 2017 China Cancer Registry Annual Report unveils the staggering landscape of this battle against the odds [3]. The canvas extends across the Pacific to the United States, where the CBTRUS Statistical Report paints a portrait of the formidable adversary that is brain and central nervous system tumors [4].

These are not just dry statistics; they are windows into a world where science and human resilience converge. They beckon us to explore, to understand, and to fight for a brighter future. It’s a quest where every reference is a clue, every citation a stepping stone towards the discovery of new horizons in medical science.

About Ascletis

Imagine a dynamic biotech powerhouse, Ascletis, lighting up the stage as it takes center spotlight on the Hong Kong Stock Exchange (1672.HK). But Ascletis isn’t your typical player; it’s a visionary, an R&D-driven innovator that doesn’t just dabble—it covers the entire spectrum, from discovery and development to the art of manufacturing and the magic of commercialization.

Now, picture this: At the helm is a seasoned management team, wielding a treasure trove of expertise and a track record that sparkles like gold. Ascletis is on a mission, laser-focused on three realms where medical needs cry out for champions: viral diseases, the enigmatic realm of non-alcoholic steatohepatitis (NASH), and the relentless battlefront of oncology.

What sets Ascletis apart? It’s not just about setting the stage; it’s about delivering an impeccable performance. With swift, precise execution, Ascletis has transformed its drug pipeline into a mesmerizing spectacle of progress. It’s not just about being in the race; it’s about leading it, on a global scale.

But what’s in this treasure chest of innovation? Ascletis proudly presents a repertoire of drug candidates that promise to redefine medical landscapes. ASC22, with the potential to rewrite the story of chronic hepatitis B (CHB). ASC40, a beacon of hope for acne sufferers. ASC40, once again, this time fighting recurrent glioblastoma with unwavering determination. ASC40, stepping onto the battlefield against NASH. ASC41, a partner in the quest against NASH’s enigma. And finally, ASC61, the bold contender in the realm of advanced solid tumors.

Ascletis isn’t just a company; it’s a symphony of scientific ambition, a beacon of hope in the world of healthcare, promising to shine brighter with each discovery.

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