Profile: Omeros Corp (OMER.OQ)
26 May 2017
Omeros Corporation, incorporated on June 16, 1994, is a biopharmaceutical company. The Company is engaged in discovering, developing and commercializing small-molecule and protein therapeutics for large-market, as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Its marketed drug product, Omidria (phenylephrine and ketorolac injection), is used during cataract surgery or intraocular lens (IOL) replacement. Omidria is derived from its PharmacoSurgery platform, which is designed for patients undergoing ophthalmological, arthroscopic, urological and other surgical procedures. Its PharmacoSurgery platform is based on low-dose combinations of the United States Food and Drug Administration (FDA) approved therapeutic agents delivered directly to the surgical site throughout the duration of the procedure to inhibit preemptively inflammation and other problems caused by surgical trauma, and to provide clinical assistances both during and after surgery.
The Company's pipeline includes clinical-stage development programs focused on complement-related thrombotic microangiopathies (TMAs); complement-mediated glomerulopathies; Huntington's disease and cognitive impairment; addictive and compulsive disorders. In addition, it had a group of preclinical programs and two additional platforms: one capable of unlocking new G protein-coupled receptor (GPCR) drug targets and the other used to generate antibodies, as of December 31, 2016. OMS103 is its PharmacoSurgery product candidate, which is developed for use during all arthroscopic procedures, including knee and shoulder arthroscopy, and completed Phase III trials in patients undergoing arthroscopic anterior cruciate ligament reconstruction and arthroscopic partial meniscectomy. OMS103 is a combination of anti-inflammatory/analgesic active pharmaceutical ingredients (APIs), specifically amitriptyline, ketoprofen and oxymetazoline, and designed to provide a multimodal approach to block preemptively the inflammatory cascade induced by arthroscopy. OMS103 is delivered directly to the joint throughout arthroscopy and is designed to act simultaneously at multiple distinct targets to block preemptively the inflammatory cascade induced by arthroscopic surgery.
Omidria is approved by the FDA for use during cataract surgery or IOL replacement surgery to maintain pupil size by preventing intraoperative miosis (pupil constriction) and to reduce postoperative ocular pain and is approved in all European Union (EU) member states for use during cataract surgery and other IOL replacement procedures to maintain mydriasis (pupil dilation), to prevent miosis and to reduce postoperative eye pain. As of December 31, 2016, Omidria is a drug product containing two APIs: ketorolac, an anti-inflammatory agent, and phenylephrine, a mydriatic, or pupil dilating, agent. These procedures are performed to replace a lens opacified by a cataract or to correct a refractive error. Omidria is added to standard irrigation solution used during cataract and lens replacement surgery and is delivered intracamerally, or within the anterior chamber of the eye, to the site of the surgical trauma throughout the procedure.
The Company's clinical programs include Mannan-binding lectin-associated serine protease-2 (MASP-2) (OMS721)-Lectin Pathway Disorders; PDE10 (OMS824)-CNS Disorders; peroxisome proliferator-activated receptor gamma (OMS405)-Addiction, and OMS201-Urology. The MASP-2 is a pro-inflammatory protein target involved in activation of the complement system. OMS721 is its lead human monoclonal antibody targeting MASP-2. OMS721 has received Orphan Drug designation for the prevention (inhibition) of complement-mediated TMAs, and Fast Track designation for the treatment of patients with Atypical Hemolytic Uremic Syndrome (aHUS). Phosphodiesterase 10 (PDE10) is an enzyme that is expressed in areas of the brain linked to diseases that affect cognition, including Huntington's disease and schizophrenia. OMS824 has received Orphan Drug designation for the treatment of Huntington's disease and Fast Track designation for the treatment of cognitive impairment in patients with Huntington's disease. OMS824 is in a Phase II clinical program for the treatment of Huntington's disease and a Phase II clinical program evaluating OMS824 for the treatment of schizophrenia.
The peroxisome proliferator-activated receptor gamma program is developing compositions that include peroxisome proliferator-activated receptor gamma agonists for the treatment and prevention of addiction to substances of abuse, which may include opioids, nicotine and alcohol. It has completed two Phase II clinical trials related to its peroxisome proliferator-activated receptor gamma program. OMS201 is its PharmacoSurgery product candidate designed for use during urological procedures, including ureterscopy for removal of ureteral or renal stones. OMS201 is a combination of ketoprofen, an anti-inflammatory API, and nifedipine, a smooth muscle relaxant API. It has completed a Phase I/Phase II clinical trial.
The Company's preclinical programs include phosphodiesterase 7 (PDE7) (OMS527), Plasmin (OMS616), MASP-3 (OMS906)-Alternative Pathway Disorders and GPCR Platform. The PDE7 program is based on its discoveries of previously unknown links between PDE7 and any addiction or compulsive disorder and between PDE7 and any movement disorders, such as Parkinson's disease. In its plasmin program, it is advancing antifibrinolytic agents for the control of blood loss during surgery or resulting from trauma, as well as for other hyperfibrinolytic states.
The Company is conducting in vivo preclinical efficacy studies and optimizing compounds for a number of targets, including GPR17, linked to myelin formation; GPR101, linked to appetite and eating disorders; GPR151, linked to schizophrenia and cognition; GPR161, which is associated with triple negative breast cancer; GPR183, linked to osteoporosis and to Epstein-Barr virus infections and related diseases, and GPR174, which appears to be involved in the modulation of the immune system and, in particular, of cytokine production and regulatory T cells, or T-regs, which are known to be important in autoimmune disease, such as multiple sclerosis, in cancer and in organ transplantation.
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SEATTLE WA 98119-4240