Lamassu Pharma LLC

May 26, 2022 12:10 UTC SP-624 has a novel epigenetic mechanism to enhance neuroplasticity in brain regions involved in depression, namely the hippocampus and prefrontal cortex MORRISVILLE, N.C.--(BUSINESS WIRE)-- Arrivo BioVenturesannounced today that the company has closed enrollment of a phase 2 clinical study with its most advanced program, SP-624, after having enrolled more than 300 patients with major depressive disorder. Arrivo expects top-line data in early Q4 2022. The study is a multicenter, double-blind, randomized, placebo-controlled study of the safety and efficacy of SP-624 in the treatment of adults with major depressive disorder. The trial is being conducted across 39 clinical trial sites in the United States with a total of 319 patients enrolled. Patients were randomized to either SP-624 or placebo once daily for four weeks. The primary endpoint is the change from baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) total score. There are also a number of standard measures as secondary endpoints for the study. SP-624 is a novel, small molecule that selectively activates a novel epigenetic mechanism known to modulate gene expression, metabolism and DNA repair. SP-624 enhances neuroplasticity in the hippocampus and augments neurotransmitter release in the prefrontal cortex in animal studies. Augmented neurotransmitter release is understood to be a key feature of many first line anti-depressants while enhanced neuroplasticity holds the potential to reprogram cell function and produce long-lasting effects. Arrivo’s portfolio also includes three other promising drug candidates. DLX-105 is single-chain variable fragment the company is delivering topically to directly treat mild to moderate plaque psoriasis. DLX-105 is currently in a small proof-of-concept study with data readout expected in mid-2022. DLX-2323 is a single-chain variable fragment inhibitor of IL-1β. IL-1β is a potent cytokine and an important mediator of acute and chronic inflammation. Finally, Arrivo is developing RABI-767, potentially the first treatment for severe acute pancreatitis. Arrivo has now taken over the lead from its strategic development partner, Lamassu Pharma, LLC, and the drug is entering the clinic in 2022. About Arrivo BioVentures, LLC Working in partnership with investors, innovators, and pharmaceutical companies, Arrivo is always seeking solutions for unmet medical needs. Arrivo has built a portfolio of diverse drug candidates with the potential to be first-in-class or best-in-class. The company stands on a solid foundation as the team has an average of more than 25 years of experience in drug development. Arrivo is founded and led by a team that has built and sold four companies in the last 15 years. Two products are currently commercially available and helping patients. Arrivo is propelled forward by its insatiable curiosity and drive to solve complex problems and help millions of patients globally. Arrivo is based in Morrisville, N.C., on the edge of Research Triangle Park. For more information, visit .

DURHAM, N.C., April 20, 2021 /PRNewswire/ -- Despite being known as "good" fat, excess unsaturated fatty acids may prove deadly for patients who develop, pancreatitis, COVID-19 and other acute illnesses. A new Mayo Clinic study led by Dr. Vijay Singh underscores the potential value of the lead therapeutic compound, RABI-767 in development by Lamassu Pharma, LLC, to treat acute pancreatitis. RABI-767 is a novel small molecule lipase inhibitor licensed from the Mayo Foundation for medical education and research focused on filling a critical, unmet clinical need for treatment of acute pancreatitis. Researchers also aim to mitigate the toxicity and organ failure associated with the disease that causes lengthy hospitalizations and death, saving lives and preserving resources. Acute pancreatitis is a leading cause of emergency department visits and more than 330,000 hospital admissions annually in the United States. Currently, no treatment exists to mitigate the life-threatening complications associated with the disease, which is on the rise worldwide. The importance of Lamassu's research is underscored by a new Mayo Clinic study on the role of unsaturated fats in pancreatitis released in Science Advances earlier this year. The researchers in this study found that the rapid breakdown of unsaturated body fat stored in a patient's body can worsen the course of severe acute pancreatitis, increasing toxicity, organ failure, and the risk of death. In healthy people, the body slowly breaks down saturated and unsaturated fats as needed to help supply energy, make hormones, promote cell-to-cell communication, or keep cells structurally healthy. In people who develop pancreatitis, however, fat stores in the body are attacked. Unsaturated, or "oily," fat breaks down into fatty acids more rapidly than saturated, or "buttery," fat. This rapid breakdown and release of excess stored unsaturated fatty acids can interfere with normal health processes vital to survival. By nature, the unsaturated fats are more water stable at warm temperatures, so they accumulate and spread more freely through the body, potentially damaging individual cells and organ systems. In addition to the Mayo Clinic research, Lamassu has completed preclinical studies on RABI-767 and the results have indicated that the therapeutic compound decreases the breakdown or release of both unsaturated and saturated fats during acute pancreatitis attacks. Lamassu anticipates receiving approval to begin clinical trials within the next few months. Researchers are closely monitoring coronavirus variants to determine whether to fast-track development of a clinical trial tailored to the efficacy of its treatment specifically for those patients with COVID-19. In patients who develop COVID-19, acute pancreatitis can be worsened by increased inflammation in the body. Multiple studies in 2020 and 2021 have indicated the pancreas as a target organ for SARS-CoV-2—the virus that causes COVID-19—because the virus' receptors are expressed in pancreatic cells, specifically the acinar and islet cells, and research into this connection is ongoing at institutions worldwide, including Lamassu. Lamassu's novel treatment—an injection direct to the pancreas—could potentially protect against this increased risk, mitigate symptoms, and help to prevent organ failure and other complications related to pancreatitis by slowing or minimizing the breakdown of unsaturated fat. If proven effective, the treatment could help save patient lives and reduce the need for costly extended care. "We have accelerated the development by tailoring the business around the science - not the other way around. When we get approval, our drug RABI-767 will be the first and only drug to be delivered via intraperitoneal injection, to preserve the science and the mechanism of action that ensure drug efficacy," said Dr. Gabi Hanna, CEO of Lamassu Pharma. "Every day there are thousands of patients suffering and dying from this disease without any hope for sufficient therapy, and our goal is to navigate the regulation and approve the safety and efficacy of our drug in order to bring it to patients as soon as possible." About Lamassu Pharma, LLC Founded in 2018, Lamassu Pharma leverages innovative and insightful technology to drive collaboration between academia and industry through translational research. Our talented team of physicians, engineers and translational scientists applies its expertise to translate the knowledge of medical research products in Phase I/II clinical trials and partners with clinical and commercial development specialists to advance clinical trials through the approval pipeline. Our innovative model ensures that early development efforts bring products to definitive clinical testing as efficiently as possible to benefit patients, while safeguarding safety and investments. Learn more at lamassupharma.com. Press Contact: Jodi Perkins 307948@email4pr.com (847) 508-0877