Spanish biopharmaceutical company aptaTargets has finalized an agreement with Merck KGaA, Darmstadt, Germany for the clinical development and commercialization of ApTOLL, a novel Toll-like receptor 4 (TLR4) antagonist being developed for acute ischemic stroke. The deal, signed in October 2024, transfers the promising neuroprotective agent to Merck's global development pipeline.
"This transaction represented an important step forward for aptaTargets and for the development of ApTOLL," explained David Segarra, co-founder and CEO of aptaTargets. "Partnering with Merck KGaA, Darmstadt, Germany, provides the resources and expertise needed to bring this potentially life-saving therapy to stroke patients worldwide."
Novel Mechanism Targets Post-Stroke Inflammation
ApTOLL represents a first-in-class neuroprotective approach that specifically targets TLR4, a receptor that plays a central role in triggering the inflammatory cascade following ischemic brain injury. By blocking TLR4 signaling, ApTOLL aims to down-regulate neuroinflammatory mechanisms that contribute to secondary brain damage after stroke.
The drug has shown promising results in early clinical testing. In a Phase 1b/2a clinical study published in JAMA Neurology, ApTOLL demonstrated positive safety and efficacy outcomes in acute ischemic stroke patients, including reduced mortality and improved functional recovery. These encouraging results led to the European Medicines Agency granting ApTOLL a PRIME (PRIority MEdicines) designation in 2023, highlighting its potential to address significant unmet medical needs.
Addressing a Major Unmet Medical Need
Stroke remains one of the leading causes of death and disability worldwide, with limited effective treatment options available beyond the acute phase. Current standard treatments focus primarily on restoring blood flow through thrombolysis or mechanical thrombectomy, but these approaches have narrow therapeutic windows and don't address the subsequent inflammatory damage.
Jan Klatt, Head of Development Unit Neurology & Immunology for the Healthcare business sector of Merck KGaA, Darmstadt, Germany, emphasized the significance of this acquisition: "Stroke is amongst the most common and disabling neurological conditions where effective treatments are still very limited. ApTOLL's novel therapeutic approach with encouraging early clinical data is complementary to our internal science targeting TLR biology. We expect the program to enter Phase 2b in 2026 and potentially become an addition to our Neurology portfolio in the future."
Transaction Details and Future Development
Under the terms of the agreement, Merck KGaA assumes responsibility for the global development and commercialization of ApTOLL, with aptaTargets providing ongoing transitional support. The financial terms include an upfront payment to aptaTargets, along with development and commercial milestone payments, and royalties on net sales. Specific financial details were not disclosed.
The acquisition aligns with Merck KGaA's strategic focus on expanding its neurology portfolio with innovative approaches to address significant unmet needs. The company plans to advance ApTOLL into Phase 2b clinical trials by 2026, building on the promising early clinical data.
About aptaTargets
Founded in 2014 by David Segarra and Maria Eugenia Zarabozo and headquartered in Madrid, Spain, aptaTargets specializes in the development of innovative therapies based on aptamer technology. The company is part of Inveready's investment portfolio and was supported by Rousaud Costas Durán for this transaction.
The transfer of ApTOLL to Merck KGaA represents a significant milestone for the Spanish biotech company and highlights the growing international interest in novel approaches to treating stroke and other neurological conditions with high unmet medical needs.
