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L&B ASSOCIATION CONSULTATANTS TRIAL

In addition, IgG IC induction of inflammatory pathways was dependent on FcRn and inhibited by SYNT001. SYNT001 decreased all IgG subtypes and IgG ICs in the circulation of humans, as we show in a first-in-human phase 1, single ascending dose study. We generated, characterized, and assessed the effects of SYNT001, a FcRn-blocking monoclonal antibody, in mice, nonhuman primates (NHPs), and humans. Many autoimmune diseases, however, are derived from the effects of IgG immune complexes (ICs). Recently, several clinical studies have reported the lowering of circulating monomeric IgG levels through FcRn blockade for the potential treatment of autoimmune diseases. The neonatal crystallizable fragment receptor (FcRn) functions as an intracellular protection receptor for immunoglobulin G (IgG). 12 Clinical Pharmacology of Miami, Miami, FL 33014, USA.11 Department of Medicine, Division of Gastroenterology, Hepatology and Nutrition, Boston Children's Hospital, Boston, MA 02115, USA.10 Department of Medicine, Division of Gastroenterology, Hepatology and Endoscopy, Brigham and Women's Hospital, Harvard Medical School, Boston, MA 02115, USA.9 The Jackson Laboratory, Bar Harbor, ME 04609, USA.8 Department of Pharmacology, Institute of Clinical Medicine, University of Oslo, Oslo 0424, Norway.7 Department of Immunology and Centre for Immune Regulation, Oslo University Hospital Rikshospitalet and University of Oslo, Oslo 0424, Norway.6 BioBridges, Wellesley, MA 02481, USA.5 New York Structural Biology Center, New York, NY 10027, USA.4 Abzena, Babraham, Cambridge, CB22 3AT, UK.3 BioProcess Technology Consultants, Woburn, MA 01801, USA.2 Biologics Consulting, Alexandria, VA 22314, USA.

1 Syntimmune Inc., Boston, MA 02116, USA.

We conclude that oral administration of L-arginine in combination with Pycnogenol causes a significant improvement in sexual function in men with ED without any side effects. Finally, after the third month of treatment, 92.5% of the men experienced a normal erection. Treatment with a combination of L-arginine and Pycnogenol for the following month increased the number of men with restored sexual ability to 80%. After 1 month of treatment with L-arginine, a statistically nonsignificant number of 2 patients (5%) experienced a normal erection. We obtained a sexual function questionnaire and a sexual activity diary from each patient. During the second month, patients were additionally supplemented with 40 mg Pycnogenol two times per day during the third month, the daily dosage was increased to three 40-mg Pycnogenol tablets.

L&B ASSOCIATION CONSULTATANTS TRIAL

Throughout the 3-month trial period, patients received 3 ampoules Sargenor a day, a drinkable solution of the dipeptide arginyl aspartate (equivalent to 1.7 g L-arginine per day).

The study included 40 men, aged 25-45 years, without confirmed organic erectile dysfunction. For this purpose, we orally administered Pycnogenol, because it is known to increase production of NO by nitric oxide syntase together with L-arginine as substrate for this enzyme. We investigated the possibility of overcoming erectile dysfunction (ED) by increasing the amounts of endogenous NO. Penile erection requires the relaxation of the cavernous smooth muscle, which is triggered by nitric oxide (NO).