January 17, 2017 9:06 AM ET


Company Overview of Karos Pharmaceuticals, Inc.

Company Overview

Karos Pharmaceuticals, Inc. operates as a pharmaceutical company focused on bone related diseases. The company was founded in 2009 and is based in New Haven, Connecticut.

5 Science Park

Suite 2

New Haven, CT 06511

United States

Founded in 2009





Key Executives for Karos Pharmaceuticals, Inc.

Karos Pharmaceuticals, Inc. does not have any Key Executives recorded.

Karos Pharmaceuticals, Inc. Key Developments

Karos Pharmaceuticals Provides Update on Developing Therapeutic Agents to Modulate Peripheral Serotonin Synthesis to Treat Orphan Indications

Karos Pharmaceuticals, Inc. provided update on developing therapeutic agents to modulate peripheral serotonin synthesis to treat orphan indications, including pulmonary arterial hypertension (PAH) and carcinoid syndrome, announced several major achievements, including the success of the Phase 1 clinical trials of KAR5585. Karos’ lead agent, KAR5585, is a novel, orally available, best in class, small molecule tryptophan hydroxylase-1 (TPH-1) selective inhibitor being developed to treat pulmonary arterial hypertension (PAH) and carcinoid syndrome. In vivo animal models have demonstrated KAR5585’s ability to reduce vascular remodeling and vascular occlusions in a dose-dependent manner when used for treatment or prevention of the disease pathophysiology and to substantially reduce pulmonary arterial hypertension when used alone or synergistically with standard of care therapies for PAH. KAR5585 met all expectations in the single and multiple ascending dose studies, demonstrating excellent safety, tolerability, robust pharmacokinetics and a dose-dependent reduction in serotonin synthesis. The pharmacokinetic data support BID and possibly QD dosing, and the human safety data confirm the safety profile seen preclinically. The KAR5585 Phase 2 studies in PAH and carcinoid are planned for 2017. KAR5585 has Orphan Designation for PAH.

Karos Pharmaceuticals Advances Development of KAR5585 to Treat Pulmonary Arterial Hypertension into the Clinic

Karos Pharmaceuticals announced that the Company has advanced its small molecule drug candidate, KAR5585, into the clinic. KAR5585 is being developed for the treatment of pulmonary arterial hypertension (PAH) and other rare diseases marked by extensive fibrosis. KAR5585 is a first-in-class, selective inhibitor of tryptophan hydroxylase 1 (TPH1) designed to reduce peripheral serotonin (5-HT) and 5-HT-associated vascular remodeling and fibrosis that are the hallmarks of PAH. Karos has completed the single ascending dose portion of its 120-patient Phase 1 clinical trial in healthy volunteers and is now conducting the multiple ascending dose portion of the study, with the goal of reporting results from the Phase 1 program in the middle of this year. Biomarkers incorporated into the multiple-dose portion of the study are expected to provide insight into the mechanism of action of the drug and the dose-range needed for reduction of peripheral 5-HT. Based on this progress, the company anticipates commencing a Phase 2 study of KAR5585 as a once-a-day treatment in patients with PAH. KAR5585 is designed to selectively modulate peripheral serotonin biosynthesis, reducing disease-related vascular remodeling, vasoconstriction, and inflammation. Discovered at Karos, KAR5585 has been shown in preclinical studies to reduce vascular remodeling and vascular occlusions in a dose-dependent manner when used for treatment or prevention of the disease pathophysiology in vivo models of PAH. KAR5585 delivered orally either in a preventive or in a therapeutic modality, reduced pulmonary arterial hypertension in the preclinical models. KAR5585 also has been studied in preclinical models in combination with agents currently used as standard-of-care (SOC) therapies for PAH, demonstrating substantial lowering of pulmonary arterial hypertension and improvement of pulmonary arterial remodeling both as compared to SOC treatments and in conjunction with those treatments. The ongoing first-in-human Phase 1 clinical program for KAR5585, expected to enroll a total of 120 healthy volunteers, is designed to evaluate safety and tolerability as primary endpoints and measure biomarkers as proof of mechanism. Following completion of both single and multiple dose ascending portions of the Phase 1 study, Karos expects to initiate a double-blind, randomized Phase 2 trial. In October 2015 Karos received U.S. FDA Orphan Disease Designation for KAR5585 in PAH.

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