We are encouraged by the quick engagement of more than 15 clinical sites across the US and rapid patient enrollment. This enthusiasm really demonstrates the continued unmet need in SR-aGVHD and desire from Key Opinion Leaders for better treatment options by leveraging the unique mechanism of action.
REDWOOD CITY, Calif. (PRWEB) September 29, 2020
AltruBio Inc. http://www.altrubio.com, a clinical stage biotech company pioneering the PSGL-1 agonist approach in Immunology, announced today the first patient has been dosed in its phase 1b trial of Neihulizumab in patients with Steroid Refractory Acute Graft Versus Host Disease (SR-aGVHD). The trial is a multi-dose study of Neihulizumab in SR-aGVHD and follows its successful Phase 1a single-dose study which demonstrated a 77% response rate.
President & CEO Dr. Judy Chou stated “We are encouraged by the quick engagement of more than 15 clinical sites across the US and rapid patient enrollment. This enthusiasm really demonstrates the continued unmet need in SR-aGVHD and desire from Key Opinion Leaders for better treatment options by leveraging the unique mechanism of action of Neihulizumab.”
The study is intended to demonstrate the safety, tolerability, and efficacy of multiple doses of Neihulizumab in SR-aGVHD. Primary endpoints include the pharmacokinetic (PK) profile and complete response rate at day 28. A number of secondary endpoints for efficacy are specified including overall response rate at day 28, duration of response, and non-relapse mortality rate at day 180.
Neihulizumab is an immune checkpoint agonist antibody targeting PSGL-1/CD162 that depletes chronically activated T cells. This mechanism has been evaluated in four autoimmune and inflammatory diseases and has demonstrated clinical proof of concept and safety in more than 160 patients. Neihulizumab has completed Phase 2 trials in Psoriasis and Psoriatic Arthritis, is closing out in a Phase 2a trial for the treatment of refractory ulcerative colitis, and is in Phase 1 trials for the treatment of SR-aGVHD, with encouraging results in patients that are refractory to available therapies. A Phase 1 trial for the treatment of front-line acute GvHD is also currently initiated.
About acute Graft-versus-Host Disease.
Acute GvHD is a major complication following an allogeneic HCT. Somewhere between 30 and 70 percent of transplant recipients develop acute GvHD. Standard first –line treatment is systemic, high-dose glucocorticoid, with around 50% response rate and are associated with clinically significant side effects. Patients who do not respond to corticosteroid treatment are considered steroid-refractory. SR-aGVHD is a significant unmet medical need and novel, effective treatments are urgently needed.
The information presented here is not intended nor implied to be a substitute for professional medical advice and should not be relied on as health or personal advice. Always seek the advice of your physician or other qualified healthcare professional with any questions you may have regarding a medical condition or treatment and before undertaking a new health care regimen, and never disregard professional medical advice or delay in seeking it.
About AltruBio Inc. (http://www.altrubio.com)
AltruBio is a privately held biotechnology company headquartered in the San Francisco Bay Area that is focused on developing novel antibody therapeutics for the treatment of immunological diseases with high unmet medical needs. Based on unique insights into immune tolerance and epitope dominance sciences, AltruBio’s pipeline includes two clinical stage product candidates: (i) Neihulizumab (AbGn-168H) an immune checkpoint agonist antibody targeting PSGL-1/CD162 that depletes unwanted activated T cells with proof of mechanism in four autoimmune and inflammatory diseases, and (ii) AbGn-107, an antibody-drug conjugate (ADC) employing a unique enzyme cleavable hydrophilic self-immolative linker and targeting a gastrointestinal tumor antigen. AbGn-107 has demonstrated encouraging results in chemo-refractory gastric, pancreatic, colorectal and biliary cancers.
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