|
|
Biotech
|
|
||
Re: OMER late breaking abstract for 11 June presentationActually I think the market-moving news from OMER is contained in the first abstract mentioned in todays press release (see below), which was selected for an oral late-breaker presentation on June 11. The first abstract (LB2714) provides an update on patients with paroxysmal nocturnal hemoglobinemia (PNH) whereas the second abstract (P787) covers healthy control subjects. Anyone who read the first quarter PR, or listened to the call, should not be surprised by this news as it was telegraphed on May 9: "In April 2023, we announced results from a pre-specified interim analysis of our ongoing Phase 1b clinical trial of OMS906 in treatment-naïve adults with PNH. Updated data from this open label trial continue to show statistically significant and clinically meaningful improvements in all measured markers of hemolysis, including hemoglobin (“Hgb”) and lactate dehydrogenase (“LDH”). Despite all patients having received only the lowest of doses planned for the trial, data compare very favorably to those publicly available for marketed and in-development alternative pathway inhibitors. Enrollment is ongoing. Updated data are provided below ..." (see PR for numbers) Press Release Omeros Corporation Announces Late-Breaking Presentation of OMS906 Data at the 2023 European Hematology Association (EHA) Congress – Late-breaking abstract detailing interim data from ongoing clinical trial of OMS906 in treatment-naïve PNH patients selected for June 11, 2023 oral presentation – SEATTLE--(BUSINESS WIRE)--Jun. 1, 2023-- Omeros Corporation (Nasdaq: OMER) today announced that data from a pre-specified interim analysis of its ongoing Phase 1b clinical trial of OMS906, the company’s lead MASP-3 inhibitor, in complement-inhibitor-naïve adults with paroxysmal nocturnal hemoglobinuria (PNH), a rare and life-threatening hemolytic blood disorder, will be shared at the 2023 European Hematology Association (EHA) Congress in Frankfurt, Germany. Identified as one of the top five late-breaking submissions by the Scientific Program Committee, the abstract was selected for oral presentation. The presentation, entitled OMS906, A mannan-binding lectin-associated serine protease-3 (MASP-3) Inhibitor, Normalizes Hemoglobin Levels in Treatment-naïve PNH Patients: Interim Data from a Proof-of-Concept Clinical Trial, will be delivered by Jens Panse, MD, Senior Physician and Deputy Director of the Department of Hematology, Oncology, Hemostaseology and Stem Cell Transplantation, University Hospital RWTH Aachen, and Managing Medical Director of the Center for Integrated Oncology, Aachen, Germany. Dr. Panse’s presentation will be delivered at the late-breaking oral session scheduled for 9:45-11:15 CEST on Sunday, June 11, 2023 and will be available by livestream to registered meeting attendees via the congress platform. The presentation abstract (#LB2714) was embargoed by EHA until 16:00 CEST today but now is freely accessible on EHA’s website. Following Dr. Panse’s presentation, Omeros will make available on its website the associated slides. Also at this EHA congress, Morag Griffin, MBChB, FRCPath, Consultant in Haematology of St. James University Teaching Hospital, Leeds, United Kingdom, will present a poster describing findings from a single-ascending dose study evaluating OMS906 safety, pharmacokinetics and pharmacodynamics in healthy subjects. Dr. Griffin’s presentation is scheduled for 18:00-19:00 CEST on Friday, June 9, 2023 and will be available for viewing by registered attendees on the online EHA platform throughout the duration of the congress (June 8-11, 2023). The presentation abstract (#P787) is available to everyone on EHA’s website. About PNH Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, life-threatening acquired disorder that causes production of red blood cells lacking certain surface proteins (CD55 and CD59), making them vulnerable to destruction by the complement system. This leads to intravascular hemolysis (destruction of red blood cells within blood vessels) and extravascular hemolysis (when damaged red blood cells are removed by macrophages in the spleen or liver). Left untreated, PNH is associated with debilitating anemia, a high risk of thrombosis, fatigue, and a severely reduced survival rate. There remains a significant unmet need for PNH therapies, as a large proportion of patients treated with C5 inhibitors continue to experience hemolysis and approximately one third of them still require red blood cell transfusions. About OMS906 OMS906 is an investigational human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), the key activator of the complement system’s alternative pathway. The complement system plays a central role in inflammation and becomes activated as a result of tissue damage or microbial infection. Responsible for the conversion of pro-complement factor D to complement factor D, MASP-3 is believed to be the premier target in the alternative pathway – it has the lowest native circulating level and low relative clearance compared to the other alternative pathway proteins and, unlike C5 and C3 blockers, MASP-3 inhibition leaves intact the lytic arm of the classical pathway, important for fighting infection. Also, unlike other components of the alternative pathway, MASP-3 is believed not to be an acute phase reactant, which could provide a significant advantage to MASP-3 inhibitors, like OMS906, over other alternative pathway inhibitors. MASP-3 inhibitors are thought to have preventive or therapeutic effects across a broad range of diseases including paroxysmal nocturnal hemoglobinuria (PNH), hemolytic uremic syndrome (HUS), atypical HUS, traumatic brain injury, arthritis, wet age-related macular degeneration, ischemia-reperfusion injury, transplant-related complications and other immune-related disorders. Through its growing and exclusive intellectual property position, Omeros controls the use of MASP-3 inhibitors across a wide range of alternative pathway-related and other diseases and disorders. |
return to message board, top of board |