Lupus News Today reported on a Phase 1 trial involving BIIB059, an antibody that targets a receptor of plasmacytoid dendritic cells. The study results were published in the Journal of Clinical Investigation. According to the published results, BIIB059 “was well-tolerated and reduced inflammation and skin lesions in systemic lupus erythematosus (SLE) patients.”
What is SLE
A chronic autoimmune disease characterized by excessive inflammation and tissue damage, includes skin rash, arthritis and nephritis (inflammation of the kidney). SLE also known as lupus, is an autoimmune disease in which the body’s immune system mistakenly attacks healthy tissue in many parts of the body. Symptoms may vary and range from mild to severe. Common symptoms include painful and swollen joints, fever, chest pain, hair loss, mouth ulcers, swollen lymph nodes, fatigue and a red rash most commonly on the face. Usual onset of age ranges from 14-45. The cause is unknown. Survival is approximately 15 year and the frequency are 2-7 per 100,000. The Lupus Foundation of America estimates that approximately 1.5 million Americans and at least 5 million worldwide have some form of lupus. There is no known cure.
What is BIIB059?
BIIB059 is an investigational humanized anti-BDCA2 monoclonal antibody. Its originator and developer are U.S.-based biotech company Biogen. In 2017, the sponsor found that it demonstrates evidence of proof of biological activity with subjects (participants) with cutaneous lupus. BDCA2 is a protein present in specific cells within the immune system. An antibody against BCDA2 can potentially interrupt production of interferons, inflammatory molecules that are increased in patients with lupus and contribute to disease activity.
Biogen’s Phase I Trial Results
The Biogen sponsored study evaluated the safety, tolerability and pharmacokinetics of single doses and multiple doses of BIIB059 in healthy volunteers and patients with systemic lupus erythematosus. Biogen did not choose to reveal the actual research sites in Clinicaltrials.gov. The trial was designed in three (3) parts including: First, evaluate the safety of increasing doses of BIIB059 on 54 healthy volunteers from ages 18 to 55. Second and third, evaluate the effects of BIIB059 on 12 adult SLE patients with mild to moderate skin lesions at the start of the trial. As it turned out, 8 patients received the antibody and 4 received the placebo.
Researchers used the Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) to determine the level of skin lesions. Lupus News Today reported that the healthy volunteers as well as SLE patients overall demonstrated good tolerance to BIIB059 doses. Some mild to moderate side effects were observed including an infection in the upper respiratory tract.
Primary outcome measures reported included Number of Participants that Experience Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to Week 32 ]. For secondary outcomes see the link to the published study.
All the participants completed the trial. The researchers we quoted in Lupus News Today that “BIIB059 is the first therapy to specifically target pDCs (plasmacytoid dendritic cells) in patients with SLE.” They continued, “our results highlight the central role of pDC-derived IFN-I in the pathogenesis of skin manifestations in SLE and suggest that targeting pDCs with BIIB059 is a promising therapy for SLE” and lupus cutaneous lesions, they stated.
As review of Biogen’s pipeline reveals the sponsor’s overview of the investigational treatment and that presently BII059 studies are in both Phase I and 2 stages.