- Aclipse plans to expand M107 (lobeglitazone), a best-in-class PPARγ activator, into nephrotic syndrome in children, including steroid-dependent and frequently relapsing disease, where it could become the first non-immunosuppressive treatment option for these children.
- The planned renal trial will run in parallel with the ongoing Mayo Clinic-sponsored Phase 2 LOGAST trial in gastroparesis, delivering dual-track M107 Phase 2 proof-of-concept readouts.
- Aclipse raising a Series B preferred equity financing to advance its expanded pipeline.
KING OF PRUSSIA, Pa.--(BUSINESS WIRE)--Aclipse Therapeutics ("Aclipse"), a clinical-stage biopharmaceutical company developing best-in-class therapies for chronic, rare, and severe diseases, today announced an agreement that provides Aclipse the option to acquire Cypress BioPharma ("Cypress"), a developer of novel therapies for rare kidney diseases. Upon completion, the transaction would establish parallel renal (M107R) and gastrointestinal (M107G) development programs for the Aclipse M107 molecule, creating two Phase 2 clinical readouts, while adding renal development expertise and additional early-stage renal assets. Completion of the transaction is subject to specified closing conditions.
Nephrotic syndrome in children is a serious kidney disorder affecting thousands of children in the United States. In severe or treatment-resistant cases, the disease can progress to chronic kidney disease and end-stage kidney disease requiring dialysis or kidney transplantation. Corticosteroids are the standard initial therapy, but recurrent, steroid-dependent, or treatment-resistant disease can require additional immunosuppressive therapy that can be associated with substantial treatment burden and toxicity. The planned M107R Phase 2 LOKID (LObeglitazone for the treatment of KIDney disease in kids) clinical trial will evaluate its potential to induce and maintain long-term remission of nephrotic syndrome. Patients and caregivers need better treatment options, including therapies that may reduce steroid exposure and address underlying disease biology.
"I am proud of our team's progress with Mayo Clinic in preparing for the M107G Phase 2 LOGAST (LObeglitazone for the treatment of idiopathic GASTroparesis) clinical trial. We now look forward to working with the Cypress BioPharma team to expand the M107 molecule into the childhood nephrotic syndrome (M107R) program, where it may offer a potential disease-modifying and steroid-sparing treatment option for children with this serious kidney disease. 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," said Raymond K. Houck, Aclipse CEO.
Despite recent advances in treatments for IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS), and the FDA's acceptance of new surrogate endpoints, children with nephrotic syndrome are still treated largely with old immunosuppressive agents, such as prednisone, which carry substantial toxicity. "Cypress was founded on the pioneering work of Dr. William E. Smoyer at Nationwide Children's Hospital, which showed that PPARγ agonists act directly on podocytes to protect them from injury. Podocytes comprise a key component of the kidney’s glomerular filtration barrier and are the key target cell of injury in nephrotic syndrome. Notably, PPARγ agonist–induced podocyte protection and proteinuria reduction, may be achieved without added steroids or other immunosuppressive drugs. The transaction with Aclipse will allow us to advance the M107 molecule, a best-in-class PPARγ activator, into childhood nephrotic syndrome and other glomerular diseases, while combining the Cypress renal development expertise with the Aclipse clinical-stage development capabilities," said Michelle Higgin, PhD, Cypress CEO.
Aclipse is initiating a Series B financing to advance the two Phase 2 development programs for M107: the Mayo Clinic-sponsored M107G Phase 2 LOGAST trial in idiopathic gastroparesis, which is undergoing final study-start-up activities; and the M107R Phase 2 LOKID trial in childhood nephrotic syndrome, planned to begin next year. The M107G and M107R programs will evaluate the potential for the M107 molecule to provide a disease-modifying treatment approach through macrophage rebalancing and cytoprotection and builds on the extensive M107 clinical safety database.
About Aclipse Therapeutics: Aclipse Therapeutics is a clinical-stage biopharmaceutical company developing disease-modifying therapies for chronic and severe diseases. Its lead program, M107G, is a best-in-class PPARγ activator in development for gastroparesis, a chronic gastrointestinal disorder characterized by nausea, vomiting, abdominal pain and delayed gastric emptying. In parallel, the Aclipse M107R program is in development for childhood nephrotic syndrome, a serious kidney disorder that can lead to progressive kidney dysfunction and, in severe cases, end-stage kidney disease requiring dialysis or kidney transplantation. Aclipse is also developing M102, an NRF2 and HSF1 activator, for amyotrophic lateral sclerosis (ALS) and traumatic brain injury (TBI) entering Phase 1, and M228 for cystinuria, a rare kidney disease.
About Cypress BioPharma: Cypress BioPharma, a spin-out from Nationwide Children’s Hospital, develops therapies for rare pediatric kidney diseases, including childhood nephrotic syndrome, focal segmental glomerulosclerosis (FSGS), and cystinuria. Cypress has built a specialized renal development team with expertise spanning regulatory, preclinical, and clinical development.
Contacts
For more information, contact Michael Kranda, Chief Business Officer, at mkranda@aclipsetherapeutics.com
Or visit www.aclipsetherapeutics.com
