Linnaeus Therapeutics, Inc., a privately held company in Haddonfield focused on the development and commercialization of small molecule therapeutics for diseases of aging, announced that it has been awarded a contract of up to $22 million from the Advanced Research Projects Agency for Health (ARPA-H).
As part of the PROactive Solutions for Prolonging Resilience (PROSPR) program, Linnaeus will advance its lead drug candidate, LNS8801, for the treatment of age-related functional decline and cancer.
This award will support a multiphase translational PROSPR research program designed to accelerate the development and evaluation of interventions that maintain physical and cognitive function and delay age-associated functional decline.
The program will assess whether activation of the G protein-coupled estrogen receptor (GPER) with LNS8801 can preserve Intrinsic Capacity, defined as the integrated physical and cognitive abilities that underpin independence and resilience later in life.
“Real-world data suggesting that women experience more favorable outcomes compared to men across multiple diseases of aging inspires our work at Linnaeus,” said Christopher Natale, Ph.D., co-founder and chief scientific officer of Linnaeus Therapeutics and principal investigator on the award.
“The PROSPR program will support studies that directly assess whether LNS8801 can preserve Intrinsic Capacity and improve healthspan.”
LNS8801 is a first-in-class, only-in-class, oral, selective agonist of GPER with clinical evidence of biological activity across multiple physiological systems implicated in age-related functional decline and cancer.
Under the PROSPR program, Linnaeus will conduct preclinical aging studies followed by a randomized clinical study in healthy older adults. These efforts will incorporate functional assessments, physiological and molecular biomarkers, and emerging measures of biological aging to enable efficient evaluation of healthspan-related outcomes.
The program also builds on prior clinical experience with LNS8801 in oncology, where more than 100 patients have been treated in a phase 1/2 study. In this study, LNS8801 demonstrated an exceptional safety and tolerability profile.
Clinical data strongly suggest improved survival in patients with cancer, as well as clinically meaningful improvements in cardiometabolic measures, including LDL cholesterol, systolic blood pressure, Hb1AC and weight loss. These data support further investigation of LNS8801 in multiple diseases of aging.
“LNS8801 has a mechanism of action expected to provide benefits in multiple organ systems,” said Patrick Mooney, M.D., chief executive officer of Linnaeus Therapeutics.
“ARPA-H’s evaluation of our data and subsequent award validates the promise of LNS8801 to potentially prevent diseases of aging and will enable a rigorous program to translate that promise into clinically meaningful improvements in healthspan-predictive outcomes.”
This ARPA-H-supported work could establish a new preventive approach to medicine, preserving function and independence, rather than treating age-related diseases after decline has occurred.
There are significant potential benefits for public health and health care sustainability.
