During the third quarter of 2021, at Oryzon we have 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 for the 30-month study, presented at the EHA2021 conference last June, showed robust signs of clinical efficacy.
In parallel, we are preparing new iadademstat assays in AML and solid tumors. In AML, the company plans to initiate FRIDA, a multicenter Phase Ib / II trial of iadademstat in combination with gilteritinib in patients with FLT3 mutation AML who are refractory or have relapsed. In small cell lung cancer (SCLC), the company is preparing the next trial, STELLAR, a multicenter, randomized Phase Ib / II trial of iadademstat with an immune checkpoint inhibitor (ICI) in patients with metastatic SCLC in first line. Both trials will be conducted in the US and both plan to recruit about 120 patients.
On the other hand, we are evaluating vafidemstat in diseases of the nervous system. We currently have 2 Phase IIb clinical trials in psychiatric illness underway. The PORTICO trial, which is already recruiting patients in Europe and the US, will evaluate the efficacy of vafidemstat in patients with Borderline Personality Disorder (BPD), with two primary objectives: (i) reduction of aggressiveness / agitation and ( ii) the overall improvement of the disease. Our other Phase IIb clinical trial is EVOLUTION, to evaluate the efficacy of vafidemstat on negative symptoms and cognition in patients with schizophrenia, which is being carried out in Spain and is also recruiting patients. Considering 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.
Additionally, we are deploying a radically innovative approach to precision medicine with vafidemstat. The scientific community has shown that LSD1 inhibitors such as vafidemstat can compensate for the effects of a number of genetic failures that occur in certain nervous system disorders such as Kabuki Syndrome (KS) and others. In collaboration with world leaders in this disease, the company is preparing a Phase I / II clinical trial with vafidemstat in patients with KS. Additionally, we have ongoing collaborations in the field 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 for Medical and Molecular Genetics. (INGEMM) from La Paz University Hospital in Madrid, and in precision medicine in schizophrenia with researchers from Columbia University in New York.
Regarding our financial results, Oryzon maintains a significantly robust financial position as of September 30, 2021, with available financial resources amounting to 30.9 million euros, which will allow us to continue with the development of our R&D activities. and the development of our clinical studies. Likewise, this strength is also seen in the balance sheet at the end of September, which shows a relevant solidity with a net worth of 73.3 million euros.
In the international environment, Oryzon maintains an increasingly prominent presence in the American market. In this context of progress and presence in the US, we have recently incorporated in New York a new Global Business Director, Dr. Saikat Nandi, who is endorsed by significant experience in the US capital markets and who is going to enable us to intensify our contacts with Wall Street and 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 both the Medical and Business Directorates of the company are headed from the US, which is part of Oryzon’s ongoing strategy to expand its presence in this country.
In short, despite the global impact produced by the coronavirus pandemic, Oryzon has continued to advance with its business strategy, as well as in the clinical development of its programs, contributing to Spain being a leading benchmark in research and scientific innovation. The PERTE Salud de Vanguardia endowed with 1,469 million euros was recently presented, which precisely pursues as one of its main objectives to promote scientific research and position Spain as a leading country in the innovation and development of advanced therapies. Within this framework, Oryzon is helping to demonstrate that in Spain there is pharmaceutical excellence and first-rate science is done.