FPR1

Adiso to Utilize Noninvasive RNA Technology Developed by Geneoscopy as a Precision Immunology Measure in ADS051 Phase 2 IBD Trial ST. LOUIS, Mo. & CONCORD, Mass.--(BUSINESS WIRE)-- Geneoscopy, Inc., a life sciences company focused on developing noninvasive diagnostic and precision medicine tools for gastrointestinal health, and Adiso Therapeutics, Inc., a clinical-stage biotechnology company advancing novel medicines to treat inflammatory diseases, today announced a strategic collaboration to further treatment options available for patients with inflammatory bowel disease (IBD). The agreement allows Geneoscopy’s patented RNA biomarker technology to be used in conjunction with ADS051, a first-in-class, oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation being developed by Adiso for the treatment of IBD. This press release features multimedia. View the full release here: “Utilizing our RNA biomarker platform to assess stool samples from IBD patients and categorize response to treatment with ADS051 is an exciting opportunity,” said Andrew Barnell, CEO of Geneoscopy. “Our technology shows significant promise to enhance IBD clinical trials by identifying patients likely to respond to a particular therapeutic and, through noninvasive methods, determining therapeutic effectiveness through the measurement of RNA expression profiles which signal mucosal healing in the colon.” “The addition of noninvasive stool-based RNA technology from Geneoscopy within our Phase 2 trial of ADS051 is a perfect complement to our neutrophil-targeted, gut-restricted, non-systemic therapy,” said Scott Megaffin, CEO of Adiso. “Employing precision immunology within our trial holds the potential to significantly advance our ability to provide IBD patients with a novel and highly differentiated treatment option that targets their specific needs.” As part of the Adiso ADS051 Phase 2 trial in patients with ulcerative colitis, Geneoscopy will prospectively assess stool-based transcriptome changes in patients treated with ADS051 to identify immunological markers that may predict individual response. Beyond its utility in identifying likely responders to therapy, preliminary research has also indicated that Geneoscopy’s RNA biomarker technology could provide a noninvasive method of determining clinical remission that is more accurate than traditional diagnostics such as fecal calprotectin. In subsequent clinical trials, Adiso will leverage the Geneoscopy biomarker panel to employ a precision immunology approach that uses stool-derived eukaryotic RNA (seRNA) to assess mucosal healing and predict patient response to therapy. This collaboration comes at a critical time for the estimated 3 million Americans living with IBD. Despite an increased focus on improving treatment and patient care, effective tools are lacking to inform therapy selection, and significant opportunities exist to advance and refine methods for disease monitoring. The Adiso ADS051 Phase 2 clinical study will be conducted globally and begin recruiting in 2024. About Geneoscopy, Inc. Geneoscopy Inc. is a life sciences company focused on developing diagnostic tests for gastrointestinal health. Leveraging its proprietary, patented stool-derived eukaryotic RNA (seRNA) biomarker platform, Geneoscopy’s mission is to empower patients and providers to transform gastrointestinal health through innovative diagnostics. Beyond colorectal cancer screening, Geneoscopy is developing diagnostic tests for treatment selection and therapy monitoring in other disease areas in partnership with leading universities and biopharmaceutical companies. For more information, visit and follow the company on LinkedIn. About Adiso Adiso is a clinical-stage biopharmaceutical company dedicated to improving the health of patients suffering from debilitating inflammatory diseases. This dedication is epitomized by our lead clinical candidates, which exemplify 'healthruption' (disruption in healthcare and drug development) with novel mechanisms of action and a distinct approach to the treatment of inflammatory diseases. ADS051, an oral, gut-restricted modulator of neutrophil trafficking and activation via inhibition of MRP2 and FPR1 for the treatment of ulcerative colitis; and ADS032, a dual NLRP1/NLRP3 inflammasome inhibitor initially being developed for inflammatory diseases of the lung. Adiso has built 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 the University College Cork, Ireland, the APC Microbiome Institute. For more information, please visit or our LinkedIn page. About ADS051 ADS051 is a novel first-in-class, oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation via MRP2 and FPR1 receptor inhibition. ADS051 is a locally acting targeted therapy that addresses the underlying pathophysiology of disease while sparing the peripheral role of neutrophil function. Unlike currently available therapies, ADS051 addresses neutrophil-mediated tissue damage, a hallmark of UC. UC is a form of IBD that causes inflammation and ulcers in the colon. Neutrophils are a type of white blood cell that plays a key role in the body's immune response. In UC, neutrophils are recruited to the colon in large numbers, where they release a variety of inflammatory mediators that cause tissue damage. ADS051 gut restriction, safety and tolerability after oral dosing has been demonstrated in a healthy subject Phase 1a clinical study. In a healthy volunteer Single Ascending Dose study and in a moderate to severe UC patient Phase 1b Multiple Ascending Dose study, oral doses of ADS051 were safe and well-tolerated and largely restricted to the gut with limited systemic exposure while demonstrating encouraging signals of pharmacologic activity and clinical benefit.

ADS051 was safe and well-tolerated at all doses with no safety signal observed Clinical remission was achieved in 22% of patients after only 28 days on drug CONCORD, Mass., Oct. 22, 2023 /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 positive topline data from its Phase 1b multiple ascending dose (MAD) clinical trial evaluating ADS051 (BT051) in patients with moderate-to-severe ulcerative colitis (UC). The data were presented today at the American College of Gastroenterology (ACG) 2023 Annual Scientific Meeting being held October 20-25, in Vancouver, Canada. ADS051 is a first-in-class, oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation via inhibition of MRP2 and FPR1. Unlike currently available therapies, ADS051 addresses neutrophil-mediated tissue damage, a hallmark of UC pathology. The randomized, double-blind, placebo-controlled, MAD Phase 1b study enrolled 24 moderately-to-severely active UC patients, all of whom completed the trial as planned over the 28-day treatment period (NCT05084261). ADS051 was found to be safe and well-tolerated at three dose levels (200, 800, and 3200 mg) administered orally, once daily for 28 days. PK data demonstrate that ADS051 was restricted to the gut with limited systemic exposure. On Day 28, for pooled ADS051 participants vs. pooled placebo participants, clinical remission was achieved in 22.2% vs. 0%, endoscopic improvement (investigator blinded, centrally-read) in 33.3% vs 0%, and endoscopic response (centrally-read) (UCEIS) was achieved in 50% vs. 17%. "We are very pleased with these positive results indicating that ADS051 clearly attained the objectives of this Phase 1b trial and may be an important therapeutic advancement as a safe and effective, once-daily oral therapy for patients with ulcerative colitis," said Scott Megaffin, Chief Executive Officer of Adiso. "ADS051 efficacy measures reveal encouraging signals of pharmacologic activity and clinical benefit versus placebo, after 28 days of treatment. Given these findings and a recently completed positive end-of-Phase 1 FDA interaction, we plan to advance ADS051 in a Phase 2 clinical study in early 2024." "Despite recent therapeutic advancements in the treatment of UC, there still remains a significant unmet need for safe and efficacious therapeutic options," said Jessica Allegretti, M.D., M.P.H Medical Director, Crohn's and Colitis Center, Brigham & Women's Hospital Boston and Associate Professor of Medicine, Harvard Medical School. "The results of this Phase 1b study demonstrate that not only is ADS051 safe and well-tolerated, it also may offer a potentially efficacious solution for patients with moderate-to-severe UC. I look forward to assessing this therapy further in a Phase 2 clinical study." The MAD clinical trial followed a healthy subject Phase 1a single ascending dose (SAD) study which demonstrated ADS051 was gut-restricted with minimal systemic drug exposure, with no dose-limiting toxicities or serious adverse events. One treatment-emergent adverse event was reported in 16.7% of patients in the pooled ADS051 group vs. 66.7% in the pooled placebo group. Safety and tolerability of the 3200-mg dose group were equivalent to the lower dose cohorts with substantially higher fecal concentrations of ADS051. The poster detailing these findings #P0172: ADS051, an Oral, Gut-Restricted, Small Molecule Neutrophil Modulator in Patients With Moderate-To-Severe Ulcerative Colitis: Results From a Multiple Ascending Dose Study, was presented at the ACG 2023 Annual Scientific Meeting, October 22, 2023, and will be available on the Company's website. About ADS051 ADS051 is a first-in-class, oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation via MRP2 and FPR1 receptor inhibition. Unlike currently available therapies, ADS051 addresses neutrophil-mediated tissue damage, a hallmark of UC. UC is a chronic IBD that causes inflammation and ulcers in the colon. Neutrophils are a type of white blood cell that plays a key role in the body's immune response. In UC, neutrophils are recruited to the colon in large numbers, where they release a variety of inflammatory mediators that cause tissue damage. ADS051 gut restriction, safety and tolerability after oral dosing has been demonstrated in a healthy subject Phase 1a clinical study. About Adiso: Adiso is a clinical-stage biopharmaceutical company dedicated to improving the health of patients suffering from debilitating inflammatory diseases. This dedication is epitomized by our lead clinical candidates, which exemplify 'healthruption' (disruption in healthcare and drug development) with novel mechanisms of action and a distinct approach to the treatment of inflammatory diseases. ADS051, an oral, gut-restricted modulator of neutrophil trafficking and activation via inhibition of MRP2 and FPR1 for the treatment of ulcerative colitis; and ADS032, a dual NLRP1/NLRP3 inflammasome inhibitor initially being developed for inflammatory diseases of the lung. 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 the University College Cork, Ireland, the APC Microbiome Institute. For more information, please visit or our LinkedIn page. Contacts Argot Partners Media: Sarah Sutton/Liza Sullivan IR: Jason Finkelstein [email protected] 212.600.1902 SOURCE Adiso Therapeutics

CONCORD, Mass., Oct. 12, 2023 /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 the appointment of Robert Lisicki to the Company's Board of Directors. "The Adiso Board and I are very pleased to welcome Robert Lisicki. Rob is an accomplished biopharma industry executive, with multiple drug approvals to his credit, and his appointment is a welcome addition," said Jason Dinges, Morningside Technology Advisory and Adiso Board Member. "Our recent progress with ADS051 in ulcerative colitis (UC) has helped solidify our position as a precision immunology company, and Rob's extensive global experience in developing treatments for inflammatory bowel disease, will help Adiso achieve even greater success. Rob's more recent work in healthcare venture companies and his service as a Director will be valuable as we continue to grow into a mature clinical stage company." "Throughout his career, Rob has contributed to complex and diverse development programs from Phase 1 to Phase 3 trials, from strategic planning and clinical study execution to regulatory submissions," added Scott Megaffin, Chief Executive Officer of Adiso. "We look forward to leveraging his expert counsel as we advance our neutrophil modulator, ADS051, into Phase 2 for the treatment of Inflammatory Bowel Disease (IBD)." Mr. Lisicki has nearly 30 years of experience in the pharma/biotech sector, most recently serving as Chief Executive Office and Board Member of InCarda Therapeutics. Previously, he was the Chief Commercial Officer of Arena Pharmaceuticals, where he provided global visionary leadership for the $6.7 billion growth-stage biopharmaceutical company through its acquisition by Pfizer in March 2022 and had a leadership role in more than $8 billion in M&A activities. Prior to Arena, Mr. Lisicki was Vice President, General Manager of Inflammation & Immunology and Cardiovascular at Regeneron Pharmaceuticals, leading both commercial and development stage efforts. Previously, Mr. Lisicki was Senior Vice President and Chief Customer Officer of Daichii-Sanyko, where he managed the successful global product launches in Cardiovascular and successful U.S. development in Pain and Oncology. Earlier in his career, Mr. Lisicki held key global roles with Amgen and various increasing roles of leadership at JNJ, Janssen Pharmaceutics. He serves as a member on the Board of Directors of Cadrenal Therapeutics and as a consultant and advisor for private and public life sciences companies. Mr. Lisicki earned his BS in Finance and Economics from State University of New York at Albany. "Adiso has undertaken a very compelling and differentiated approach to the treatment of inflammation, using technology that precisely halts the resulting dysregulation. I look forward to working with this talented team to advance ADS051, an exciting compound that specifically targets neutrophils and MRP2 in IBD," said Mr. Lisicki. About ADS051 ADS051 is a first-in-class, oral, gut-restricted, small molecule modulator of neutrophil trafficking and activation via MRP2 and FPR1 receptor inhibition. Unlike currently available therapies, ADS051 addresses neutrophil-mediated tissue damage, a hallmark of UC. UC is a chronic IBD that causes inflammation and ulcers in the colon. Neutrophils are a type of white blood cell that plays a key role in the body's immune response. In UC, neutrophils are recruited to the colon in large numbers, where they release a variety of inflammatory mediators that cause tissue damage. ADS051 gut restriction, safety and tolerability after oral dosing has been demonstrated in a healthy subject Phase 1a clinical study. Results from a recently completed Phase 1b multiple ascending dose trial in UC patients will be presented at an upcoming major medical conference. About Adiso: Adiso is a clinical-stage biopharmaceutical company dedicated to improving the health of patients suffering from debilitating inflammatory diseases. This dedication is epitomized by our lead clinical candidates, which exemplify 'healthruption' (disruption in healthcare and drug development) with novel mechanisms of action and a distinct approach to the treatment of inflammatory diseases. ADS051, an oral, gut-restricted modulator of neutrophil trafficking and activation via inhibition of MRP2 and FPR1 for the treatment of ulcerative colitis; and ADS032, a dual NLRP1/NLRP3 inflammasome inhibitor initially being developed for inflammatory diseases of the lung. 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 the University College Cork, Ireland, the APC Microbiome Institute. 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 View original content to download multimedia: SOURCE Adiso Therapeutics