July 26, 2014 7:15 AM ET

Biotechnology

Company Overview of Resolve Therapeutics, LLC

Company Overview

Resolve Therapeutics, LLC, a biotechnology company, is developing biologic compounds to treat patients suffering from lupus, a chronic systemic autoimmune disease that attacks and damages kidneys, skin, heart, and joints. It is developing RSLV-125, a biologic compound, which inhibits the interferon-alpha pathway and molecular pathways involved in the pathophysiology of lupus. The company was incorporated in 2010 and is based in Kirkland, Washington.

5400 Carillon Point

Kirkland, WA 98033

United States

Founded in 2010

Phone:

425-576-4100

Key Executives for Resolve Therapeutics, LLC

Co-Founder and Chief Executive Officer
Co-Founder
Compensation as of Fiscal Year 2014.

Resolve Therapeutics, LLC Key Developments

Resolve Therapeutics, LLC Announces Initiation of a Multi-Dose, One Month Phase 2 Clinical Study

Resolve Therapeutics, LLC announced the initiation of a multi-dose, one month phase 2 clinical study with its lead compound RSLV-132 in systemic lupus erythematosus (SLE). Following the successful completion of it phase 1 single dose safety study with RSLV-132, Resolve recently initiated a phase 2 study in lupus patients. The study will be conducted at multiple sites in the U.S., and will investigate four dose levels, with multiple doses being administered over one month. The study is designed to establish biological proof-of-concept for RSLV-132. RSLV-132 is a novel Fc fusion protein consisting of human RNase attached to the Fc portion of human IgG. The goal of the therapy is to reduce the burden of circulating RNA-containing immune complexes which are thought to be the most proximal trigger of the systemic inflammation characteristic of SLE. By eliminating the RNA cargo contained in circulating immune complexes the therapy is designed to prevent chronic activation of nucleic acid sensing toll like receptors and subsequent activation of the interferon inflammatory cascade. Additional therapeutic benefit is thought to result from dampening B-cell activation, as well as mitigation of the direct tissue damage caused by immune complex deposition in key organs, such as the kidney and brain.

Resolve Initiates RSLV-132 Clinical Studies

Resolve Therapeutics, LLC announced the initiation of clinical studies with its lead compound RSLV-132. Resolve administered the first doses to humans of RSLV-132 its first-in-class targeted nuclease therapy designed to decrease the burden of circulating RNA-containing immune complexes in SLE patients. Ongoing studies are designed to evaluate the safety, tolerability, pharmacokinetics and biological activity of RSLV-132. A single escalating dose study in healthy volunteers began earlier this month, with a multi-dose study in SLE patients planned to begin in the second quarter of 2014. RSLV-132 is a novel Fc fusion protein consisting of human RNase to the Fc portion of human IgG. The goal of the therapy is to reduce the burden of circulating RNA-containing immune complexes which are thought to be the most proximal trigger of the systemic inflammation characteristic of SLE. By eliminating the RNA cargo contained in circulating immune complexes the therapy is designed to prevent chronic activation of nucleic acid sensing toll like receptors (e.g TLR7 and TLR8) and subsequent activation of the interferon inflammatory cascade. Additional therapeutic benefit is thought to result from dampening B-cell activation, as well as mitigation of the direct tissue damage caused by immune complex deposition in key organs, such as the kidney and brain.

Takeda Pharmaceutical Company Limited and Resolve Therapeutics, LLC Enter Autoimmune Partnership

Takeda Pharmaceutical Company Limited and Resolve Therapeutics, LLC jointly announced that they have entered into a partnership to develop compounds for the treatment of lupus (also known as Systemic Lupus Erythematosus, or SLE) and other autoimmune diseases. The lead compound, RSLV-132, a novel nuclease Fc fusion protein, will begin clinical development later 2013. Additional Resolve clinical candidates are in the pre-clinical proof-of-concept stage. These compounds target the degradation and elimination of autoantibody-containing immune complexes, which are thought to be the most proximal pathophysiological trigger of lupus. Resolve will conduct all development work under the collaboration until completion of the first RSLV-132 Phase 1b/2a trial in lupus patients. Takeda has the exclusive option to license the lead compound and all other compounds from the Resolve platform upon the completion of the Phase 1b/2a trial. Upon exercise of its option, Takeda would assume lead responsibility for worldwide development and commercialization of the Resolve products. Under the terms of the agreement, Takeda will help fund continued development of RSLV-132 through an initial payment of $8 million to Resolve in fiscal 2012. Upon exercise of its option, Takeda would pay Resolve an option exercise fee, plus the potential for additional development milestones totaling $247 million. Furthermore Resolve is eligible to receive royalties on product sales.

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