KING OF PRUSSIA, PA — Aclipse Therapeutics secured an option to acquire Cypress BioPharma, a deal that would expand its lead M107 drug candidate into childhood nephrotic syndrome and give the company two parallel Phase 2 development programs as it raises Series B financing to fund its pipeline.
The transaction, subject to closing conditions, would add Cypress’s renal development expertise and two early-stage kidney drug candidates to Aclipse’s portfolio. It would also establish separate renal and gastrointestinal programs for M107, or lobeglitazone.
Aclipse plans to begin a Phase 2 trial of M107 in children with nephrotic syndrome next year. The LOKID study will evaluate whether the drug can induce and maintain long-term remission, including in children with steroid-dependent and frequently relapsing disease.
The company is positioning M107 as a potential non-immunosuppressive treatment that could reduce reliance on corticosteroids and other immunosuppressive drugs. Corticosteroids remain the standard initial treatment for childhood nephrotic syndrome, while recurrent, steroid-dependent or resistant disease can require additional immunosuppression.
M107 is a PPARγ activator. Cypress’s development strategy is based on research showing that PPARγ agonists act directly on podocytes, cells that are part of the kidney’s glomerular filtration barrier, to protect them from injury.
“PPARγ agonist-induced podocyte protection and proteinuria reduction may be achieved without added steroids or other immunosuppressive drugs,” Cypress Chief Executive Officer Michelle Higgin said.
The renal program would run alongside Aclipse’s M107 program in idiopathic gastroparesis. The Mayo Clinic-sponsored Phase 2 LOGAST trial is undergoing final study-start-up activities.
The two trials would provide separate Phase 2 proof-of-concept assessments for M107, with the renal program designated M107R and the gastrointestinal program M107G.
“The proposed transaction would establish parallel renal and GI development programs for the M107 molecule, add experienced renal development expertise, and add two early-stage kidney drug candidates into the Aclipse pipeline,” Chief Executive Officer Raymond K. Houck said.
Aclipse is initiating a Series B preferred-equity financing to advance both Phase 2 programs. The company plans to evaluate M107 as a potential disease-modifying treatment through macrophage rebalancing and cytoprotection, building on an existing clinical safety database for the molecule.
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