Avizorex Pharma SL

VIENNA, Austria, Aug. 01, 2022 (GLOBE NEWSWIRE) -- The AOP Health Group (AOP Health) is a European pioneer for integrated therapies for rare diseases and in critical care headquartered in Vienna, Austria. The company focuses on research, development and global sales of innovative treatment solutions and specializes in therapies for rare diseases and intensive care. In early July, AOP Health signed an agreement with Leukos Biotech, a spin-off company founded by the Barcelona-based Josep Carreras Leukaemia Research Institute. The agreement signed by AOP Health covers the option for developments of the newly discovered chemical substance within any treatable indication, not limited to oncological or rare diseases. Agreement sets basis for new areas of therapy At first, AOP Health will focus on the development of treatment options for Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). Both are special disease types of leukemia that often start in the bone marrow. Agnes Kohl, Chief Business Officer of AOP Orphan Pharmaceuticals GmbH, Member of the AOP Health Group explains: “Based on positive data, our plan is to expand the development for further orphan indications even outside of AML and MDS at a later stage. With this agreement, we may be able to broaden the portfolio within our therapeutic areas offering even more treatment options for patients.” Development in cooperation with Leukos As AOP Health focuses on rare, hemato-oncological cancers and has many years of experience in the development and commercialization of hemato-oncological treatments, the company will drive the further development of the substance in cooperation with Leukos based on a new mode of action. This could potentially turn into a milestone in the treatment of many blood cancer and other cancer patients. Luis Ruiz-Avila, Chief Executive Officer of Leukos Biotech: “We focus on developing new treatments for a wide variety of tumors. We were born to transform excellent science from the Josep Carreras Leukaemia Research Institute into valuable products for cancer patients in need, and this agreement is a very significant step in that direction. We are convinced that AOP Health is the right partner to turn this promising, novel mechanism of action into a clinical reality for the benefit of patients in a wide variety of unmet medical needs”. About AOP Health The AOP Health Group incorporates several companies including AOP Orphan Pharmaceuticals GmbH with its seat in Vienna, Austria (“AOP Health”). The AOP Health Group is the European pioneer for integrated therapies for rare diseases and in critical care. Over the past 25 years, the Group has become an established provider of integrated therapy solutions operating from its headquarters in Vienna, its subsidiaries and representative offices throughout Europe and the Middle East, as well as through partners worldwide. This development has been made possible by a continually high level of investment in research and development on the one hand and a highly consistent and pragmatic orientation towards the needs of all its stakeholders on the other – especially the patients and their families as well as also the healthcare professionals treating them. About Leukos Leukos Biotech, SL (Leukos) is a spin-off company from the Josep Carreras Leukaemia Research Institute incorporated in Barcelona in 2015. The company is developing new treatments and diagnostic tools for a wide variety of tumors targeting the serotonin receptor HTR1B, which antitumoral potential was first described and patented by Leukos’ founder Dr. Ruth Risueño in her laboratory at the Josep Carreras Research Institute. Leukos’ main financial support is from private and institutional investors. The main shareholders are Inveready, CDTI Innvierte and the Josep Carreras Foundation. Besides investors’ support, Leukos has received non-dilutive grants and loans from the Catalan Government, the Spanish Government and the European Union in various programs. About the Josep Carreras Foundation The Josep Carreras Leukaemia Foundation was established in 1988 with the intention of contributing to finding a definitive cure for this disease. Its efforts are concentrated on four basic areas: administering the Spanish Bone Marrow Donor Registry (REDMO), scientific research, carried out by the Josep Carreras Leukaemia Research Institute, patient guidance through an online patient consultation channel, and reception apartments for patients who need to undergo treatment and have to spend a long time far from home. About the Josep Carreras Leukaemia Research Institute The Josep Carreras Leukaemia Research Institute, a public centre pertaining to the Generalitat de Catalunya's CERCA network, was established in 2010 with the aim of furthering biomedical research and personalised medicine in the field of leukaemia and other onco-hematological diseases. It is the first research centre in Europe exclusively focussed on leukaemia and malignant blood diseases, and one of the very few in the world. The Josep Carreras Institutes has three coordinated but independent scientific campuses: University of Barcelona Hospital Clínic Campus, The Catalan Institute of Oncology/Germans Trias i Pujol Campus, and the Sant Pau - Autonomous University of Barcelona (UAB) Campus About Inveready Inveready is a leading alternative asset manager in Spain - investing in early-stage VC, growth VC, venture debt, strategic equity in listed companies, infrastructure and private equity - providing financing solutions to companies throughout their life-cycle. Founded in 2008, Inveready counts on 200 active companies, and more than €1bn of assets under management. Inveready has been investing in companies in the Life Sciences sector since 2008. Notable investments in this vertical are Atrys Health (listed on the Spanish market), EDESA Biotech (listed on Nasdaq), AVX Pharma (sold to Aerie Biotech) and PaloBiofarma (licensing agreement with Novartis). Inveready is headquartered in San Sebastian, and has other offices in Barcelona and Madrid. It has been recognized on multiple occasions by ASCRI and Preqin for the return on its funds and transactions (For more information, visit www.inveready.com).

Aerie’s dry eye disease drug may not have met the primary endpoints it’s chosen for a Phase IIb study, but that’s not stopping the biotech from powering through Phase III — and steering toward a field with plenty of rivals. “While we did not achieve statistical significance at our pre-determined primary endpoints at Day 28, as a reminder, this is a Phase 2b study where selecting primary endpoints are not required,” CEO Vicente Anido said in a statement. Instead, he highlighted how AR-15512, a TRPM8 agonist given in the form of an eye drop, spurred statistically significant improvements on “multiple FDA-recognized symptoms and signs” — things like ocular discomfort, tear production and eye dryness. All of that, he added, points to a clear path toward approval. Investors aren’t so sure. Shares $AERI fell 17.83% after the bells to $2.80. Based on the results, execs have decided to bring the higher concentration of 0.003% BID into two Phase III trials that will stretch over three months. With Novartis’ blockbuster Xiidra already on the market, the FDA is in no rush to clear new treatments for dry eye disease, rejecting Kala’s initial NDA and demanding a new Phase III before finally approving its ocular corticosteroid, Eysuvis. But biotechs have argued that the market remains untapped and there’s still need for more options. A total of 369 patients enrolled in the COMET-1 study into one of three arms: AR-15512 (0.0014%), AR-15512 (0.003%) or AR-15512 vehicle. Dosed daily over 84 days, they were evaluated at days 1, 14, 28 and 84. Unusual for a data readout, Aerie didn’t provide a p-value on the primary endpoints — or even mention them — for the topline. According to its posting on clinicaltrials.gov, the primary outcome measures of the COMET-1 study are improvement from baseline in ODS-VAS, or ocular discomfort score on a visual analogue scale, and improvement on the anesthetized Schirmer’s score. There was no word on how patients fared on those two metrics in a press release. Instead, the company highlighted how the drug cleared the bar for ocular discomfort at day 84 (p=0.028), SANDE (symptom assessment in dry eye) at days 14, 28 and 84 (p-value between 0.025 and 0.0005) and eye dryness at day 84 (p=0.03). It also reported positive results in signs like efficacy after the first dose, tear production based on the unanesthetized Schirmer’s score, conjunctival redness and ocular surface staining. Less than 3% of participants discontinued the trial due to adverse events, Aerie added, and they concluded both formulations tested were safe and well-tolerated. Aerie will see what the FDA thinks of its plan in an end of Phase II meeting planned for early next year — although the rest of the world may not find out until much later. AR-15512 came to Aerie — which already boasts of several approved drugs in glaucoma — via its 2019 buyout of Spain’s Avizorex Pharma. The upfront payment came in at $10 million, perhaps reflecting the sales expectation.“We would look for AR-15512 to match the efficacy of approved dry eye disease therapeutics (in terms of both dry eye disease signs and symptoms) with peak sales of ~$230 mil (indication would be worth $4). If efficacy is significantly above on-market products, our peak sales estimates could be ~$500 mil (indication would be worth $9),” Mizuho analysts wrote in a recent note.