AltruBio Announces First Patient Dosed in Phase 1b Study of Neihulizumab in Patients with Steroid-Refractory Acute Graft-versus-Host Disease
The multi-dose study follows the successful Phase 1a single-dose study of Neihulizumab which demonstrated a 77% response rate.
REDWOOD CITY, Calif., Sept. 29, 2020 /PRNewswire-PRWeb/ -- 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.
About Neihulizumab.
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.
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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.
Note on Forward-Looking Statements
Statements made in this news release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as expects, believes, intends, and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as the Company's ability to raise additional capital, and risks related to the Company's ability to initiate, and enroll patients in, planned clinical trials. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by law.
SOURCE AltruBio Inc.
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