During the third quarter of 2021, at Oryzon, we maintained our traditional high investment rate, reaching 9.6 million euros in R&D, mainly for the clinical development of our iadademstat oncology and vafidemstat neurology programs.
Currently, the first of these is being evaluated in a phase II clinical trial (ALICE) investigating its use in patients with acute myeloid leukemia (AML) in combination with azacitidine and has recently completed recruitment. . Preliminary results from the 30-month study, presented at the EHA2021 conference last June, showed strong signs of clinical efficacy.
At the same time, we are preparing new iadademstat tests in AML and solid tumors. In AML, the company plans to initiate FRIDA, a Phase Ib / II multicenter study of iadademstat in combination with gilteritinib in patients with a refractory or relapsing FLT3 AML mutation. In small cell lung cancer (SCLC), the company is preparing the next trial, STELLAR, a multicentre randomized Phase Ib / II trial of iadademstat with an immune checkpoint inhibitor (ICI) in patients with SCLC metastatic in the first line. Both trials will be conducted in the United States and both plan to recruit around 120 patients.
On the other hand, we evaluate the vafidemstat in diseases of the nervous system. We currently have 2 phase IIb clinical trials in psychiatric illnesses underway. The PORTICO trial, which is already recruiting patients in Europe and the United States, will assess the efficacy of vafidemstat in patients with borderline personality disorder (BPD), with two main objectives: (i) reduction of blood pressure aggressiveness / restlessness and (ii) disease amelioration. Our other Phase IIb clinical trial is EVOLUTION, to assess the efficacy of vafidemstat on negative symptoms and cognition in patients with schizophrenia, which is being conducted in Spain and is also recruiting patients. Given the significant side effect profile of atypical antipsychotics used to treat schizophrenia, vafidemstat has enormous potential to be a safe, effective and well-tolerated treatment option for treating the underlying cognitive dysfunction and negative symptoms of schizophrenia. schizophrenia.
In addition, we are deploying a radically innovative approach to precision medicine with vafidemstat. The scientific community has shown that LSD1 inhibitors such as vafidemstat can offset the effects of a number of genetic failures that occur in certain nervous system disorders such as Kabuki syndrome (SK) and others. In collaboration with the world leaders in this disease, the company is preparing a Phase I / II clinical trial with vafidemstat in patients with KS. In addition, we have ongoing collaborations in the area of precision medicine in autism with researchers at the Seaver Center for Autism Research and Treatment at the Icahn School of Medicine at Mount Sinai Hospital in New York and with the Institute of Medical and Molecular Genetics. (INGEMM) at La Paz University Hospital in Madrid, and in precision medicine in schizophrenia with researchers at Columbia University in New York.
Regarding our financial results, Oryzon maintains a significantly solid financial position as of September 30, 2021 with available financial resources amounting to € 30.9 million, which will allow us to pursue the development of our R&D activities and the development of our clinical studies. Likewise, this solidity is also reflected in the balance sheet at the end of September, which shows a relevant solidity with a net wealth of 73.3 million euros.
In the international environment, Oryzon maintains an increasingly important presence in the American market. In this context of progress and presence in the USA, we recently integrated in New York a new Global Business Director, Dr. Saikat Nandi, who benefits from a significant experience in the American capital markets and who will allow us to intensify our contacts with Wall Street and to strategically advance the business and achieve the next phase of Oryzon’s growth objectives. Dr Saikat will lead the strategic alliances that will define Oryzon’s portfolio going forward. His appointment means that the company’s medical and sales departments are led from the United States, which is part of Oryzon’s continued strategy to expand its presence there.
In short, despite the global impact produced by the coronavirus pandemic, Oryzon has continued to progress in its commercial strategy, as well as in the clinical development of its programs, helping to make Spain a benchmark in research and development. scientific innovation. The LOSS Salud de Vanguardia endowed with 1,469 million euros was recently presented, which pursues precisely as one of its main objectives to promote scientific research and to position Spain as a leading country in innovation and development of advanced therapies. In this context, Oryzon helps to demonstrate that in Spain there is pharmaceutical excellence and that the science is of the first order.
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