Denali Therapeutics Announces Initiation of Phase 2 Study by Partner Sanofi
Denali Therapeutics Inc. recently announced its partner Sanofi has commenced dosing in a Phase 2 study of DNL758 (SAR443122), a peripherally-restricted small molecule inhibitor of RIPK1, in patients with cutaneous lupus erythematosus (CLE).
“We are delighted that our collaborators at Sanofi are advancing DNL758 into a Phase 2 study in patients with CLE and are excited about the potential of bringing a life-changing therapy to patients through our partnership,” said Ryan Watts, PhD, Denali’s Chief Executive Officer.
Denali and Sanofi entered into a broad collaboration in October 2018 for the global development and commercialization of RIPK1 inhibitors. This includes peripherally restricted molecules, such as DNL758 and CNS-penetrant molecules, such as DNL788 (SAR443820), which is being evaluated in a Phase 1 study in healthy volunteers with potential development for neurological indications, such as amyotrophic lateral sclerosis, multiple sclerosis, and Alzheimer’s disease. Under the agreement, Denali will receive a milestone payment of $15 million related to the Phase 2 study with DNL758 from Sanofi. Sanofi is responsible for the development and commercialization of DNL758 and covers all costs related to DNL758. Denali is entitled to receive development, regulatory, and sales milestone payments and royalties on product sales.
RIPK1 is a critical signaling protein in the tumor necrosis factor (TNF) receptor pathway and is a regulator of inflammation and cell death. CLE is a type of interface dermatitis characterized by immune cell infiltration, and inhibition of RIPK1 activity is considered a novel approach to modulate the pathophysiology of CLE. Further information on the Phase 2 clinical study of DNL758 for CLE (study number NCT04781816) can be accessed on the ClinicalTrials.gov website or by clicking here.
Denali Therapeutics is a biopharmaceutical company developing a broad portfolio of product candidates engineered to cross the blood-brain barrier (BBB) for neurodegenerative diseases. Denali pursues new treatments by rigorously assessing genetically validated targets, engineering delivery across the BBB and guiding development through biomarkers that demonstrate target and pathway engagement. Denali is based in South San Francisco. For more information, visit www.denalitherapeutics.com.
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