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Enrollment complete for the high-dose third cohort of Phase 1b study of ADS051 in patients with moderate-to-severe ulcerative colitis Company presents new preclinical data supporting continued advancement of ADS032, a novel dual inhibitor of inflammasomes for inflammatory diseases and the company's Single Strain Live Biotherapeutic Product (SS-LBP) in models of Parkinson's disease and the Gut-Brain Axis CONCORD, Mass., Oct. 6, 2022 /PRNewswire/ -- Adiso Therapeutics, Inc., a clinical-stage biotechnology company committed to creating medicines that treat inflammatory diseases and improve the lives of patients and their families, today announced that enrollment in the third cohort of its Phase 1b study of ADS051 for the treatment of moderate-to-severe ulcerative colitis is complete. Last month, Adiso presented new data at several medical meetings highlighting progress across its pipeline of assets for the treatment of inflammatory diseases, including ADS032, a novel dual inhibitor of inflammasomes and ADS024 in Parkinson's disease, further exploring the relationship of the gut-brain axis in neuro inflammation. "We are very pleased to confirm all patients have been enrolled into the ascending dose cohorts, with the third cohort enrollment of our Phase 1b study of ADS051 for ulcerative colitis, an important milestone for Adiso," said Scott Megaffin, Chief Executive Officer, Adiso Therapeutics. "We share in the excitement of our investigators for this new therapeutic approach for ulcerative colitis patients. We believe that ADS051, a novel, first in class, gut restricted neutrophil modulator, has the potential to bring hope to those suffering from this chronic disease." Adiso continues to make significant progress across its pipeline. In September, the company presented data at two medical meetings on ADS032, a novel dual NLRP1/3 inflammasome inhibitor, designed to work at the site of inflammation. This compound has the potential to be applied to a wide range of inflammatory diseases, with initial development targeting respiratory and dermal conditions with significant unmet medical need. Adiso also presented data at a third medical meeting from a preclinical study of ADS024, an oral single strain live biotherapeutic product, exploring the gut-brain axis. This highly encouraging data demonstrated the potential of ADS024 to prevent dopamine loss, demonstrating improved motor movement in animal models. "We are grateful to our collaborators at the University of Edinburgh, The University of Massachusetts Chan Medical School, The Hudson Institute of Medical Sciences, and APC Microbiome Ireland for their continued partnership, and believe these presentations are a strong reflection of Adiso's commitment to advance these programs for the benefit of patients and families affected by inflammatory diseases," said Megaffin. Highlights from the Adiso September 2022 Medical Meeting Presentations: European Respiratory Society International Congress 2022 (September 6, 2022): In a poster titled, "Dynamic Microscopic Imaging and Molecular Characterisation of Alveolar Macrophage Drug Effects of a Labelled Inflammasome Inhibitor in the Human Lung (ADS032)," researchers described an ex vivo study done in collaboration with the University of Edinburgh of ADS032, the first dual inflammasome inhibitor of NLRP1 and NLRP3. In the study, the researchers used an ex vivo ventilated human lung system to study drug uptake and effect within the alveolar space. The study demonstrated uptake of labelled ADS032 by target lung cells and a reduction in the inflammasome-mediated release of interleukin -1β, a key mediator of the inflammatory response. These positive ex vivo lung results support similar studies of ADS032 in patients using a Ph0 micro dosing approach, to initiate later this year. Taken together, these pulmonary studies will define effective human doses in patients with inflammasome-driven respiratory diseases as Adiso advances ADS032 to an IND application in 2023. The International Congress of Parkinson's Disease and Movement Disorders (September 17, 2022): Adiso scientist Susan Acton presented a poster titled "ADS024 Attenuates Striatal Dopamine Loss and Restores Movement in Animal Models of Parkinson's Disease." ADS024 is an oral single strain live biotherapeutic product (SS-LBP). In the study, treatment with ADS024 improved dopamine and DOPAC striatal levels in an MPTP mouse model of Parkinson's and led to improved motor movement in an MPTP zebrafish model. Together, these results suggest that ADS024 could potentially have a positive impact on patients with Parkinson's disease by preventing dopamine loss and improving motor movement. The International Cytokines and Interferon Society Meeting (September 21, 2022): In a poster titled, "A Novel Dual NLRP1 and NLRP3 Inflammasome Inhibitor for the Treatment of Inflammatory Diseases," researchers from Adiso and The University of Edinburgh described how ADS032 is designed to target inflammasome-mediated inflammation. The study showed that ADS032 is an effective NLRP1 and NLRP3 antagonist in human macrophages and epithelial cells. In a preclinical murine model, the drug reduced pulmonary inflammation caused by pandemic influenza A virus infection. Adiso is developing ADS032 as a potential therapeutic to treat pulmonary NLRP1- and NLRP3-associated inflammatory diseases. About ADS051 ADS051 is an oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation for the treatment of ulcerative colitis. Unlike currently available therapies, ADS051 addresses neutrophil-mediated tissue damage, a hallmark of UC pathology. It is currently being evaluated in a Phase 1b randomized, double-blind, placebo-controlled, multiple ascending dose study in patients with moderately-to-severely active UC (NCT05084261). The primary objectives of this study are safety and tolerability with a secondary objective of pharmacokinetics, and exploratory objectives of reduction of neutrophil-associated biomarkers. About ADS024 ADS024 is an oral single strain live biotherapeutic product (SS-LBP) for the treatment of mild-to-moderate ulcerative colitis and for the prevention of C. difficile recurrence. It was isolated as a single, naturally occurring bacterial strain and is manufactured from a pure, clonal bacterial cell bank, yielding a standardized lyophilized drug product thus eliminating the need to directly source from donor fecal material or assemble a multistrain consortium. Clinical application of therapeutic bacteria represents a new approach in the future treatment for a range of human diseases. ADS024 has improved gut barrier integrity in rodent models of ulcerative colitis and is being studied in a Phase 1b trial of C. difficile recurrence. ADS024 has been granted Fast Track Designation by the FDA for the prevention of recurrence in patients with C. difficile infection. About ADS032 ADS032 is a novel small molecule inhibitor that locally blocks two types of inflammasomes simultaneously, NLRP1 and NLRP3 - the innate immune system's receptors and first-line sensors of pathogens and other danger signals. Chronic activation of NLRP3 and NLPR1 is directly implicated in a wide range of inflammation-triggered conditions across multiple organ systems. By targeting both NLRP1 and NLRP3, ADS032 may provide a comprehensive anti-inflammatory approach across a range of diseases. About Adiso: Adiso is a clinical-stage biopharmaceutical company dedicated to improving the lives of patients and their families by creating new medicines to treat inflammatory diseases. This dedication is epitomized by our lead clinical candidates, ADS051, an oral, gut-restricted modulator of neutrophil trafficking and activation for the treatment ulcerative colitis; and ADS032, a dual NLRP3/NLRP1 inflammasome inhibitor initially being developed for inflammatory diseases of the lung; and ADS024, an oral single strain live biotherapeutic product (SS-LBP) for the treatment of ulcerative colitis and prevention of C. difficile recurrence. Adiso has built these development programs upon a rich history of institutional and academic collaboration, including, the University of Massachusetts Chan Medical School, the Hudson Institute of Medical Sciences Centre for Innate Immunity and Infectious Diseases in Australia, the University of Edinburgh Centre for Inflammation Research, and APC Microbiome Ireland, University College Cork, Ireland. For more information, please visit or our LinkedIn page. Contacts Argot Partners Media: Sarah Sutton/Liza Sullivan IR: Jason Finkelstein Adiso@argotpartners.com 212.600.1902 Adiso Therapeutics, Inc. Jennifer Locke, Chief Operating & Business Officer pr@adisotx.com 978.202.4335 View original content to download multimedia: SOURCE Adiso Therapeutics

Adiso Therapeutics, Inc., a clinical-stage biotechnology company committed to creating medicines that treat inflammatory diseases and improve the lives of patients and their families, today announced the completion of patient enrollment in the Phase 1b clinical study evaluating ADS024, an orally delivered single strain live biotherapeutic product (SS-LBP), for the prevention of C. difficile infection (CDI) recurrence. This Phase 1b study is a randomized, placebo-controlled, double-blind, multi-site study in which 36 subjects have been enrolled in two cohorts (A & B). Each patient had a recent CDI and had completed a standard of care course of antibiotics. These patients had been determined to have achieved clinical cure based on signs and symptoms. They were then randomized to 7 or 28 single daily doses of ADS024 or placebo (NCT04891965). Half of the enrolled subjects had experienced their first CDI while the other half had experienced >1 CDI recurrences. Primary endpoints are safety and tolerability. ADS024 clinical activity will be determined by the prevention of CDI recurrence through week 12 (cohort A) or week 16 (cohort B). Topline data are expected in the third quarter of 2022. "In CDI, current standard of care antibiotics can disrupt gut microbiota, resulting in the recurrence of C. difficile infection. The subsequent toxin-mediated damage can lead to impaired quality of life for the patient and significant healthcare costs," said Scott Megaffin, Chief Executive Officer, Adiso. "The burden of treating CDI recurrence is significant and there's a tremendous opportunity for new modalities, like ADS024 which in preclinical studies has demonstrated an ability to kill C. difficile and degrade its toxins. The potential clinical application of a live biotherapeutic that is not dependent upon the need for engraftment, nor the requirement for fecal matter transplant, and that allows the patient's normal microbiota to recover represents a breakthrough."