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Aclipse Therapeutics Announces $2.2 Million Grant for Development of M102
RADNOR, Pa.–(BUSINESS WIRE)– Aclipse Therapeutics (“Aclipse” or “the Company”), a private biopharmaceutical company, today announced that the Company and its collaborator, The Sheffield Institute for Translational Neuroscience (SITraN) at the University of Sheffield in the United Kingdom (UK), were awarded a drug development research grant of £1.6 million (approximately US $2.2 million) from the UK’s Medical Research Council (MRC), one of the largest funders of medical research worldwide, to support the translational development of M102. M102 is Aclipse’s drug candidate for the treatment of amyotrophic lateral sclerosis (ALS), also referred to as motor neuron disease (MND) or Lou Gehrig’s disease.
M102 is a potentially disease-modifying drug candidate that has shown promise to impede ALS disease progression in a wide array of preclinical models. Currently, there is no cure for ALS and there are no effective treatments to halt or slow the progression of the disease.
“This development funding from MRC is wonderful news for ALS/MND patients who are in dire need of an effective therapy to address this life-threatening neurodegenerative disease,” stated Professor Dame Pamela Shaw, M.D., Director of SITraN and a primary contributor to M102’s development program. “Along with my SITraN colleagues, Dr. Richard Mead and Dr. Laura Ferraiuolo, we spearheaded the ALS/MND biology research that led to the development of M102, including the discovery of a potential precision medicine approach for M102 in ALS/MND, so we are very appreciative of MRC’s funding support.”
Aclipse is taking a multiple biological pathway, multiple disease mechanism approach to ALS. M102 activates the NRF2 (nuclear factor erythroid 2-related factor 2) and HSF1 (Heat shock factor 1) signaling pathways, which are recently understood to impact ALS pathophysiology. M102 is expected to be mechanistically superior to currently available drugs and may lead to significant slowing of disease progression in both familial and sporadic ALS.
The MRC grant will also support the development of patient stratification biomarkers that will be applied in the M102 clinical studies, potentially enabling a personalized medicine approach in ALS. The goal of the patient stratification biomarkers is to identify M102 drug responders versus non-responders in order to target M102 to those ALS patients most likely to benefit from the drug.
“We greatly appreciate the support from MRC for our novel and broad multi-disease patho-mechanism approach to treating ALS patients,” said Raymond K. Houck, CEO of Aclipse Therapeutics. “The MRC award, coupled with our recent FightMND grant award, accelerates M102’s development into its first-in-human clinical studies and validates M102’s biology and potential for a precision medicine approach for the treatment of ALS.”
“The research funding from these programs will be key as they will support the completion of our investigational new drug (IND)-enabling work and the regulatory filings for first-in-human studies. Importantly, M102 may have applications in a wide array of conditions associated with impaired neuronal function such as Friedreich’s ataxia, Huntington’s disease and Parkinson’s disease,” added Mr. Houck.
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