ApTOLL completed a Phase 1b/2 clinical trial for acute ischemic stroke with positive results. Merck KGaA, Darmstadt, Germany, to assume clinical development and commercialization of ApTOLL.
aptaTargets, a Spanish biopharmaceutical company, has announced an agreement with Merck KGaA, Darmstadt, Germany, signed in October 2024, for the clinical development and commercialization of ApTOLL, a Toll-like receptor 4 (TLR4) antagonist being developed for acute ischemic stroke.
“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”, said Segarra.
ApTOLL is a first-in-class neuroprotective drug that acts on the Toll-like receptor 4 (TLR4) with high specificity, blocking the inflammatory response that occurs after an ischemic stroke. TLR4 signaling is suggested to be central to the innate inflammation induced by acute ischemic injury and inhibiting TLR4 aims to down-regulate neuroinflammatory mechanisms. In a Phase 1b/2a clinical study, published in JAMA Neurology1, ApTOLL demonstrated positive safety and efficacy results for acute ischemic stroke, including reduced mortality and improved functional recovery. In 2023 ApTOLL was granted a PRIME designation from the European Medicines Agency in 2023.
”Stroke is amongst the most common and disabling neurological conditions where effective treatments are still very limited”, said Jan Klatt, Head of Development Unit Neurology & Immunology for the Healthcare business sector of Merck KGaA, Darmstadt, Germany. “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.”
Under the terms of the agreement, Merck KGaA, Darmstadt, Germany, assumes responsibility for the global development and commercialization of ApTOLL, with aptaTargets providing ongoing transitional support. The transaction included an upfront payment to aptaTargets, along with development and commercial milestone payments, and royalties on net sales.
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. aptaTargets is an Inveready portfolio company and was supported by Rousaud Costas Durán for the transaction.
Hernández-Jiménez,
M., et al. (2023). Safety and efficacy of ApTOLL in patients with ischemic
stroke undergoing endovascular treatment: A phase 1/2 randomized clinical
trial. JAMA Neurology, 80(8), 779-788. https://doi.org/10.1001/jamaneurol.2023.1660