SERCA

CROWN POINT, Ind., Oct. 3, 2023 /PRNewswire/ -- Neurodon, a pharmaceutical company focused on the discovery and development of novel therapies for neurodegeneration, diabetes, and rare disease, announced today that it has been awarded approximately $2.9 million in continued funding under its Small Business Innovation Research (SBIR) grant from the National Institute on Aging (NIA) of the National Institutes of Health (NIH). This grant will be used for continued development and Investigational New Drug (IND)-enabling studies to support clinical translation of the company's small molecule activators of the SERCA enzyme for Alzheimer's disease. Neurodon's novel molecules have demonstrated neuroprotective properties and the ability to improve learning and memory in several preclinical models of Alzheimer's disease. To date, the company has been awarded over $5 million in funding from the NIA for their Alzheimer's disease therapeutic development program. "We are extremely grateful for the NIA's continued support of our molecules targeting neuron loss in Alzheimer's disease," said Russell Dahl, Ph.D., Founder and CEO of Neurodon and the Principal Investigator of the grant. "This funding, which supports the completion of key studies required to submit an IND to the FDA and start clinical trials, is further validation that SERCA activation is a promising strategy for the development of disease-modifying agents for Alzheimer's disease and has the potential to bring hope to patients and their loved ones." As in their previously funded Alzheimer's disease research, Neurodon will team up with scientists in the Purdue Animal Behavioral Core (PBAC) at the Purdue Institute for Integrative Neuroscience. Purdue University is a top public research institution with world-class research facilities and faculty. "All of us at the Purdue Institute for Integrative Neuroscience are grateful to have this opportunity to partner with Neurodon. Alzheimer's disease is one of our institute's strategic initiatives and we are glad to be a part of these efforts. We would like to thank the NIA for their tremendous support and to Neurodon for inviting us to be part of the team," stated Wendy Koss, Ph.D., Director of the PBAC and Assistant Research Professor at Purdue University. "The NIA has been very supportive of our Alzheimer's disease research, providing not only critical funding but also comprehensive resources for small business development," added Colleen Mauger, R.N., Vice President of Operations at Neurodon. "This funding, in addition to investments we have recently received for other pipeline programs, further validates our platform and positions Neurodon well to be able to submit at least 2 IND applications to the FDA in the next 12-24 months." About Neurodon Neurodon is developing disease-modifying drugs for neurodegeneration, diabetes, and other life-threatening and rare diseases. Neurodon's patented molecules target fundamental pathways of cellular stress that are at the root cause of many devastating diseases. Neurodon deploys its proprietary platform technology to discover small molecule new chemical entities that correct cellular dysfunction and have demonstrated the ability to reverse the disease state in multiple preclinical models. For more information, visit . Contact: Colleen Mauger 219-225-2104 366268@email4pr.com

Evidence that 13-M, a unique small molecule disruptor of adrenergic SERCA2 activity reduces infarct size and preserves cardiac function OSLO, Norway, Aug. 29, 2023 /PRNewswire/ -- Serca Pharmaceuticals, a cardioprotection company that is developing 13-M, a novel first-in-class treatment for minimising the tissue damage that occurs with blood reperfusion post myocardial infarction (MI) and stenting, today presented exciting preclinical data showcasing its novel therapeutic strategy targeting the SERCA2 complex to protect heart tissue from ischemia-reperfusion injury at the European Society of Cardiology Congress 2023, the world's largest cardiology congress, in Amsterdam, The Netherlands, 25–28 August 2023. The findings presented suggest that specifically blocking the adrenergic regulation of SERCA2-activity is beneficial and provide evidence that small molecular protein to protein interaction (PPI) disruptors with this mechanism, such as Serca's lead product 13-M, reduce infarct size and preserve cardiac function. 13-M, is a small, first-in-class NCE shown to have important protein to protein interaction (PPI) characteristics with the capacity to modulate the SERCA2 Ca2+ pump and is the first small molecule to target the AKAP18d-PLB interaction. The compound could be transformative in treating cardiology patients who are impacted by MI and stenting and is currently in preclinical drug development. MI is one of the leading causes of death and disability worldwide, affecting approximately seven million people each year. Without treatment, 30% of MI patients will go on to develop heart failure. Infarct size is the biggest predictor of post-MI heart failure. Supported by over a decade of research in signalling pathways and SERCA2, 13-M has shown a 30% reduction in infarct size in preclinical models; in the clinic, >10% infarct reduction is considered meaningful. Kjetil Hestdal, Chief Executive Officer said, "This marks yet another important step forward in the development of much-needed novel treatments for acute myocardial infarction and associated heart failure. Our findings presented at the ESC Congress show that by targeting regulation of the SERCA2 complex, we can potentially protect against myocardial ischemia-reperfusion injury. We are aiming to develop 13-M as a breakthrough treatment for patients impacted by MI and stenting, that we anticipate will fulfil the significant unmet need of preserving heart tissue and function." The Company is on track for IND filing in 2024 to begin Phase 1 studies later that year. Details of the poster which was presented on the 28th August, are as follows: Abstract: New therapeutic strategy targeting regulation of the SERCA2 complex protects from myocardial ischemia-reperfusion injury Authors: Ana I. Calejo1,2, Ellen Østensen 1, Magnus Aronsen34, Brigitte Lygren1, Jonas Skogestad3,4, Jo Klaveness5, Ivar Sjaastad3, and Kjetil Taskén1,6 1 University of Oslo, Centre Molecular Medicine Norway, EMBL Partnership, Oslo, Norway 2 Serca Pharmaceuticals AS 3 Oslo University Hospital Ulleval, Inst. For Experimental Medical Research 4 Inst. Of Basic Medical Sciences, University of Oslo, Oslo, Norway 5 Institute of Pharmacy, Oslo, Norway 6 Inst. Cancer Research, University Hospital, Oslo, Norway For further details on the poster, please contact Tove Flem Jacobsen, or visit the Serca Pharmaceuticals website: . Company representatives will also be attending the LSX Nordic Congress being held on the 10-11 October and look forward to meeting investors and potential partners. About Serca Pharmaceuticals Serca is a cardioprotection company that is developing 13-M, a novel first-in-class treatment for minimising tissue damage that occurs with blood reperfusion post myocardial infarction (MI) and stenting. MI is one of the leading causes of death and disability worldwide, affecting approximately seven million people each year. Without treatment, 30% of MI patients will go on to develop heart failure. Infarct size is the biggest predictor of post-MI heart failure and 13-M has shown a 30% reduction in infarct size in preclinical models; in the clinic >10% infarct reduction is considered meaningful. Serca is partnered with Cadila Pharmaceuticals, one of India's largest private pharmaceutical companies. SOURCE Serca Pharmaceuticals

First-in-class, cardioprotective drug with potential to transform treatment following myocardial infarction and stenting OSLO, Norway, May 22, 2023 /PRNewswire/ -- Serca Pharmaceuticals, a Cardioprotection company that is developing 13-M, a novel first in class treatment for minimising tissue damage that occurs with blood reperfusion post myocardial infarction (MI) and stenting, today announces that it presented data on a novel approach to modulate the Beta-adrenergic receptor-cAMP protein kinase A (PKA) signalling pathway that modulates the contractility at Heart Failure 2023, the world leading event on heart failure, in Prague, Czech Republic, 20-23 May 2023. The study aimed to find small molecular compounds that disrupt the AKAP18d-PLB protein to protein interaction which is specifically found in heart tissue, as this may protect from ischemia reperfusion injury in the treatment of acute myocardial infarction (heart attack). 13-M is a small NCE shown to have these important protein to protein interaction (PPI) characteristics with the capacity to modulate the SERCA2 Ca2+ pump. Targeting the AKAP18d-PLB interaction in this way, prevents the activation of SERCA2 and the Ca transport out of cytosol - and the contractile force and energy consumption upon adrenergic stress is reduced, without any effect on the patient's heart rate. MI is one of the leading causes of death and disability worldwide, affecting approximately seven million people each year. Without treatment, 30% of MI patients will go on to develop heart failure. Infarct size is the biggest predictor of post-MI heart failure and supported by over a decade of research in signalling pathways and SERCA2, 13-M has shown a 30% reduction in infarct size in preclinical models; in the clinic >10% infarct reduction is considered meaningful. Kjetil Hestdal, Chief Executive Officer said: "These studies are an important step forward in the treatment of acute myocardial infarction and its consequences, and our findings presented at the HF 2023 conference, demonstrate that further development of 13-M as a highly promising cardioprotective therapy is warranted. We are excited by the progress we are making towards the development of a breakthrough new treatment for MI patients, that we expect to preserve heart tissue and function, a significant unmet need." The Company was granted a number of Composition of Matter patents for 13-M in 2017, which provide protection to 2037 in key commercial areas and it is on track for IND filing in 2024 to begin Phase 1 studies later that year. Details of the poster which was presented on the 21st May, are as follows: Abstract: A novel drug candidate targeting the adrenergic regulation of the SERCA complex to protect the heart from myocardial infarct injury Authors: Ana I. Calejo1,2, Ellen Østensen 1, Magnus Aronsen3,4, Brigitte Lygren1, Jonas Skogestad3,4, Jo Klaveness5, Ivar Sjaastad3, and Kjetil Taskén1,6 1 University of Oslo, Centre Molecular Medicine Norway, EMBL Partnership, Oslo, Norway 2 Serca Pharmaceuticals AS 3 Oslo University Hospital Ulleval, Inst. For Experimental Medical Research 4 Inst. Of Basic Medical Sciences, University of Oslo, Oslo, Norway 5 Institute of Pharmacy, Oslo, Norway 6 Inst. Cancer Research, University Hospital, Oslo, Norway About Serca Pharmaceuticals Serca is a Cardioprotection company that is developing 13-M, a novel first in class treatment for minimising tissue damage that occurs with blood reperfusion post myocardial infarction (MI) and stenting. MI is one of the leading causes of death and disability worldwide, affecting approximately seven million people each year. Without treatment, 30% of MI patients will go on to develop heart failure. Infarct size is the biggest predictor of post-MI heart failure and 13-M has shown a 30% reduction in infarct size in preclinical models; in the clinic >10% infarct reduction is considered meaningful. Serca is partnered with Cadila Pharmaceuticals, one of India's largest private pharmaceutical companies. SOURCE Serca Pharmaceuticals