The Decision to grant is a formal communication from the JPO in which it indicates that a patent application has reached the status where it is allowed for issuance as a patent. Both patents, once granted, will not expire until at least 2040, excluding any potential patent term extensions that may provide additional protection. Corresponding patent applications are pending in several additional major pharmaceutical markets.
Oryzon had recently received Decision to grant communications from the European and Korean patent offices for additional important patents for vafidemstat, covering its use for the treatment of aggression and social withdrawal. A corresponding patent has already been granted in
“We are delighted to have obtained allowance for these two Japanese patent applications, which further strengthen the multiple layers of protection we have built around vafidemstat,” said
“Our growing intellectual property portfolio reinforces the unique value proposition for vafidemstat, extending substantially its commercial life in CNS indications with large market potential like BPD or ADHD,” stated Dr.
About Oryzon
Founded in 2000 in
About Vafidemstat
Vafidemstat (ORY-2001) is an oral, CNS-optimized LSD1 inhibitor. The molecule acts on several levels: it reduces cognitive impairment, including memory loss and neuroinflammation, and at the same time has neuroprotective effects. In animal studies vafidemstat not only restores memory but reduces the exacerbated aggressiveness of SAMP8 mice, a model for accelerated aging and Alzheimer’s disease (AD), to normal levels and also reduces social avoidance and enhances sociability in murine models. In addition, vafidemstat exhibits fast, strong, and durable efficacy in several preclinical models of multiple sclerosis (MS). Oryzon has performed two Phase IIa clinical trials in aggressiveness in patients with different psychiatric disorders (REIMAGINE) and in aggressive/agitated patients with moderate or severe AD (REIMAGINE-AD), with positive clinical results reported in both. Additional finalized Phase IIa clinical trials with vafidemstat include the ETHERAL trial in patients with Mild to Moderate AD, where a significant reduction of the inflammatory biomarker YKL40 has been observed after 6 and 12 months of treatment, and the pilot, small-scale SATEEN trial in Relapse-Remitting and Secondary Progressive MS, where anti-inflammatory activity has also been observed. Vafidemstat has also been tested in a Phase II in severe Covid-19 patients (ESCAPE) assessing the capability of the drug to prevent ARDS, one of the most severe complications of the viral infection, where it showed significant anti-inflammatory effects in severe Covid-19 patients. Vafidemstat is being investigated in neuropsychiatric disorders in two double-blind, randomized, placebo-controlled Phase IIb trials: one in schizophrenia, named EVOLUTION (recruitment ongoing), and another one in Borderline Personality disorder (BPD), named PORTICO, finalized and with published topline data. Based on PORTICO’s results, the company has requested an End-of-Phase II meeting with the FDA to discuss options for a registrational Phase III trial in BPD. The company is also deploying a CNS precision medicine approach with vafidemstat in genetically-defined patient subpopulations of certain CNS disorders and is preparing a clinical trial in Kabuki Syndrome patients. The company is also exploring the clinical development of vafidemstat in other neurodevelopmental syndromes.
FORWARD-LOOKING STATEMENTS
This communication contains, or may contain, forward-looking information and statements about Oryzon, including financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, and expectations with respect to future operations, capital expenditures, synergies, products and services, and statements regarding future performance. Forward-looking statements are statements that are not historical facts and are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” and similar expressions. Although Oryzon believes that the expectations reflected in such forward-looking statements are reasonable, investors and holders of Oryzon shares are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Oryzon that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include those discussed or identified in the documents sent by Oryzon to the Spanish Comisión Nacional del
IR, US | IR & Media, | Oryzon | |
Atrevia | Chief Business Officer | ||
+1 617 430 7577 | +41 78 680 05 38 | +34 91 564 07 25 +34 673 33 97 65 | +34 93 515 1313 |
arr@lifesciadvisors.com | svonderweid@lifesciadvisors.com | pcobo@atrevia.com mcordera@atrevia.com | etorrell@oryzon.com |
Source:
2024 GlobeNewswire, Inc., source