Keros to Launch DMD Trial and Pursue ALS Phase II, Backed by $200M Takeda Deal
Keros Therapeutics will initiate its rinvatercept DMD trial this quarter and engage regulators on an ALS phase II program later this year. The company holds $383 million cash runway into early 2028 and posted a $200 million upfront plus over $1.1 billion in milestones from Takeda for its elritercept partnership.
1. Pipeline Milestones and Clinical Plans
Keros plans to start its rinvatercept (KER-065) Duchenne muscular dystrophy trial this quarter and engage with regulators in the second half of the year to design a phase II study in amyotrophic lateral sclerosis. The company’s focus on these neuromuscular indications follows preclinical rationale for muscle regeneration and aims to address severe, progressive diseases with high unmet need.
2. Phase I Safety and Pharmacology
In Phase I studies, rinvatercept was generally well tolerated across single ascending doses up to 5 mg/kg and multiple ascending doses for three months, with no dose-limiting toxicities or serious adverse events. Pharmacology signals included increased lean mass, greater thigh muscle volume, improved bone mineral density and bone biomarkers, along with reductions in whole-body and visceral fat.
3. Partnership and Financial Runway
Keros secured a global license agreement with Takeda for elritercept that provided a $200 million upfront payment and potential milestones exceeding $1.1 billion, plus tiered royalties. The company reported $383 million in cash, supporting operations into the first half of 2028 and funding ongoing development of its neuromuscular and hematologic programs.