This is a randomized, placebo-controlled, double-blind, multi-site study in which up to approximately 36 subjects with a recent C. difficile infection (CDI) who have completed a standard of care course of CDI antibiotics and have achieved clinical cure based on signs and symptoms, will be randomized to 7 or 28 daily doses of ART24 or placebo. Subjects will be followed for 6 months after the last dose of study drug.

Start Date27 Feb 2020

Sponsor / Collaborator

Adiso Therapeutics, Inc.

100 Clinical Results associated with ART24

100 Translational Medicine associated with ART24

100 Patents (Medical) associated with ART24

Literatures (Medical) associated with ART24

24 Aug 2023·World journal of gastrointestinal pathophysiology

Novel, non-colonizing, single-strain live biotherapeutic product ADS024 protects against Clostridioides difficile infection challenge in vivo.

Article

Author: O'Donnell, Michelle M ; Hegarty, James W ; Rea, Mary C ; Farquhar, Ronald ; Murphy, Christopher K ; Hill, Colin ; Chesnel, Laurent ; Schulz, Sarah ; Ross, R Paul

BACKGROUND:

The Centers for Disease Control and Prevention estimate that Clostridioides difficile (C. difficile) causes half a million infections (CDI) annually and is a major cause of total infectious disease death in the United States, causing inflammation of the colon and potentially deadly diarrhea. We recently reported the isolation of ADS024, a Bacillus velezensis (B. velezensis) strain, which demonstrated direct in vitro bactericidal activity against C. difficile, with minimal collateral impact on other members of the gut microbiota. In this study, we hypothesized that in vitro activities of ADS024 will translate in vivo to protect against CDI challenge in mouse models.

AIM:

To investigate the in vivo efficacy of B. velezensis ADS024 in protecting against CDI challenge in mouse models.

METHODS:

To mimic disruption of the gut microbiota, the mice were exposed to vancomycin prior to dosing with ADS024. For the mouse single-dose study, the recovery of ADS024 was assessed via microbiological analysis of intestinal and fecal samples at 4 h, 8 h, and 24 h after a single oral dose of 5 × 10⁸ colony-forming units (CFU)/mouse of freshly grown ADS024. The single-dose study in miniature swine included groups that had been pre-dosed with vancomycin and that had been exposed to a dose range of ADS024, and a group that was not pre-dosed with vancomycin and received a single dose of ADS024. The ADS024 colonies [assessed by quantitative polymerase chain reaction (qPCR) using ADS024-specific primers] were counted on agar plates. For the 28-d miniature swine study, qPCR was used to measure ADS024 levels from fecal samples after oral administration of ADS024 capsules containing 5 × 10⁹ CFU for 28 consecutive days, followed by MiSeq compositional sequencing and bioinformatic analyses to measure the impact of ADS024 on microbiota. Two studies were performed to determine the efficacy of ADS024 in a mouse model of CDI: Study 1 to determine the effects of fresh ADS024 culture and ADS024 spore preparations on the clinical manifestations of CDI in mice, and Study 2 to compare the efficacy of single daily doses vs dosing 3 times per day with fresh ADS024. C. difficile challenge was performed 24 h after the start of ADS024 exposure. To model the human distal colon, an anerobic fecal fermentation system was used. MiSeq compositional sequencing and bioinformatic analyses were performed to measure microbiota diversity changes following ADS024 treatment. To assess the potential of ADS024 to be a source of antibiotic resistance, its susceptibility to 18 different antibiotics was tested.

RESULTS:

In a mouse model of CDI challenge, single daily doses of ADS024 were as efficacious as multiple daily doses in protecting against subsequent challenge by C. difficile pathogen-induced disease. ADS024 showed no evidence of colonization based on the observation that the ADS024 colonies were not recovered 24 h after single doses in mice or 72 h after single doses in miniature swine. In a 28-d repeat-dose study in miniature swine, ADS024 was not detected in fecal samples using plating and qPCR methods. Phylogenetic analysis performed in the human distal colon model showed that ADS024 had a selective impact on the healthy human colonic microbiota, similarly to the in vivo studies performed in miniature swine. Safety assessments indicated that ADS024 was susceptible to all the antibiotics tested, while in silico testing revealed a low potential for off-target activity or virulence and antibiotic-resistance mechanisms.

CONCLUSION:

Our findings, demonstrating in vivo efficacy of ADS024 in protecting against CDI challenge in mouse models, support the use of ADS024 in preventing recurrent CDI following standard antibiotic treatment.

Biomedicines

The Urgent Threat of Clostridioides difficile Infection: A Glimpse of the Drugs of the Future, with Related Patents and Prospects

Review

Author: Imran, Mohd. ; Elmigdadi, Fayig ; Hudu, Shuaibu Abdullahi ; Alshrari, Ahmed S.

Clostridioides difficile infection (CDI) is an urgent threat and unmet medical need. The current treatments for CDI are not enough to fight the burden of CDI and recurrent CDI (r-CDI). This review aims to highlight the future drugs for CDI and their related patented applications. The non-patent literature was collected from PubMed and various authentic websites of pharmaceutical industries. The patent literature was collected from free patent databases. Many possible drugs of the future for CDI, with diverse mechanisms of action, are in development in the form of microbiota-modulating agents (e.g., ADS024, CP101, RBX2660, RBX7455, SYN-004, SER-109, VE303, DAV132, MET-2, and BB128), small molecules (e.g., ridinilazole, ibezapolstat, CRS3123, DNV3837, MGB-BP-3, alanyl-L-glutamine, and TNP-2198), antibodies (e.g., IM-01 and LMN-201), and non-toxic strains of CD (e.g., NTCD-M3). The development of some therapeutic agents (e.g., DS-2969b, OPS-2071, cadazolid, misoprostol, ramoplanin, KB109, LFF571, and Ramizol) stopped due to failed clinical trials or unknown reasons. The patent literature reveals some important inventions for the existing treatments of CDI and supports the possibility of developing more and better CDI-treatment-based inventions, including patient-compliant dosage forms, targeted drug delivery, drug combinations of anti-CDI drugs possessing diverse mechanisms of action, probiotic and enzymatic supplements, and vaccines. The current pipeline of anti-CDI medications appears promising. However, it will be fascinating to see how many of the cited are successful in gaining approval from drug regulators such as the US FDA and becoming medicines for CDI and r-CDI.

Frontiers in microbiology

ADS024, a Bacillus velezensis strain, protects human colonic epithelial cells against C. difficile toxin-mediated apoptosis

Article

Author: Pothoulakis, Charalabos ; Koon, Hon Wai ; Feng, Hanping ; Chupina Estrada, Andrea ; Chesnel, Laurent ; Xie, Ying ; Nelson, Becca

Clostridioides difficile infection (CDI) causes intestinal injury. Toxin A and toxin B cause intestinal injury by inducing colonic epithelial cell apoptosis. ADS024 is a Bacillus velezensis strain in development as a single-strain live biotherapeutic product (SS-LBP) to prevent the recurrence of CDI following the completion of standard antibiotic treatment. We evaluated the protective effects of the sterile filtrate and ethyl acetate extract of conditioned media from ADS024 and DSM7 (control strain) against mucosal epithelial injury in toxin-treated human colonic tissues and apoptosis in toxin-treated human colonic epithelial cells. Ethyl acetate extracts were generated from conditioned culture media from DSM7 and ADS024. Toxin A and toxin B exposure caused epithelial injury in fresh human colonic explants. The sterile filtrate of ADS024, but not DSM7, prevented toxin B-mediated epithelial injury in fresh human colonic explants. Both sterile filtrate and ethyl acetate extract of ADS024 prevented toxin-mediated apoptosis in human colonic epithelial cells. The anti-apoptotic effects of ADS024 filtrate and ethyl acetate extract were dependent on the inhibition of caspase 3 cleavage. The sterile filtrate, but not ethyl acetate extract, of ADS024 partially degraded toxin B. ADS024 inhibits toxin B-mediated apoptosis in human colonic epithelial cells and colonic explants.

News (Medical) associated with ART24

27 Feb 2023

·www.pharmaceutical-technology.com

Is the microbiome therapy hype up for a reckoning?

Image Credit: Shutterstock / KingVector In the last decade, the idea of tapping into the gut has attracted much interest from investors and the public, but recent years have showed that a lot more work needs to be done before such treatments enter the mainstream. This is largely due to the FDA’s rigorous approach to the safety of microbiome therapeutics, which has manifested in clinical holds, resulting in delays that have dimmed the enthusiasm in the space in recent times. Finch Therapeutics’s Phase III PRISM4 trial for recurrent Clostridioides difficile infection (CDI) and MaaT Pharma’s Phase III trial in steroid-resistant acute graft-versus-host disease were both put on hold. While the French MaaT Pharma has submitted further information to the FDA, its trial remains on hold. In January 2023, Finch announced plans to scrap the PRISM4 trial altogether. The idea behind these treatments relies on altering the gut microbiome by designing therapeutics that contain bacteria derived from donated stool samples. In November 2022, Ferring Pharmaceuticals’s Rebyota became the first FDA-approved microbiome-based therapeutic to treat recurrent CDI. But the approval came through after an FDA Advisory Committee meeting. Moreover, the Covid-19 pandemic put a spotlight on microbiome-based therapeutics due to the potential transmission risks in this class. “This whole field has been set back a little bit by the pandemic. We lost three years,” says Dr. Susy Hota, infectious disease specialist at University Health Network, University of Toronto. Coupled with this, the harsh conditions of the biotech market affected some companies. On February 16, the microbiome therapeutics-focused biotech 4D Pharma was pulled from the London Stock Exchange after falling into administration in June 2022. When Finch decided to end the PRISM4 program, it announced plans to reduce its workforce by 95%. Back in April 2022, the microbiome-focused biotech Kaleido Therapeutics folded due to financial and regulatory setbacks. Although there was a lot of hype surrounding the microbiome about five years ago, it is a question if this is still the case, says Hota. Also, microbiome therapies need to work in other indications for continued interest. “If recurrent CDI is the main indication, it is not an extremely attractive area to a lot of people,” says Hota. Regulatory concerns remain Overall, microbiome research has not advanced as much as expected, which is partly due to safety issues, says Hota. Though the pandemic disrupted research in general, it was particularly difficult to conduct research that relied on stool samples, adds Hota. Such caveats centre around the risk of infection caused by different diseases such as Covid-19 and mpox. In March 2020, the FDA shared a safety alert on the use of faecal microbiota transplants (FMTs) due to Covid-19, which added questions identifying those infected with Covid-19 to donor screening protocols. More than two years later, the FDA shared a similar alert that requested additional protections on the use of FMTs due to the mpox virus. These safety concerns froze research, says Dr. Sarah McGill, associate professor of medicine at the University of North Carolina School of Medicine, Chapel Hill. “It will take some time for research to thaw,” she adds. McGill says she does not know of a single confirmed case of Covid-19 transmission through FMTs. The best approach here would be to screen every sample, but that raises questions on the sustainability of such protocols, Hota notes. Wild west of development Currently, the sector is in its “wild west stage,” says Jack Gilbert, PhD, professor in paediatrics and the Scripps Institution of Oceanography, University of California San Diego. Although research here is about 20 years old, it remains new compared to other areas like genomics, says Gilbert. To an extent, the use of FMT in CDI paved the way for microbiome therapies, says Dr. Neilanjan Nandi, associate professor of clinical medicine at the University of Pennsylvania, Philadelphia. While Rebyota was the first to be approved, more could be coming up soon, says Gilbert. Rebyota is a faecal microbiota-based treatment for patients with recurrent CDI that is administered through an enema. In the Phase III PUNCH CD3 trial, Rebyota was superior to placebo in the reduction of CDI recurrence, with a 70.6% treatment success rate after eight weeks compared to 57.5% with placebo. Seres Therapeutics’s SER-109 is under Priority Review and the FDA has set a PDUFA date of April 26, 2023, for its use as a treatment for recurrent CDI. Unlike Rebyota, SER-109 comes in capsule form and is taken over the course of three days. Elsewhere, Vedanta Biosciences aims to bring its oral CDI treatment VE303 into a Phase III trial this year. Vedanta is a subsidiary of Puretech Health. Destiny Pharma’s CDI treatment NTCD-M3 is expected to enter a Phase III next year. Unlike Rebyota and SER-109, Vedanta’s treatment is based on clonal bacteria strains and does not use donated stool samples. CDI should be seen as only the beginning, says Nandi, adding that inflammatory bowel disease (IBD) is also an interesting avenue . However, the results here are quite mixed, say Hota and McGill. For instance, Seres’s Phase IIb study of SER-287 to treat ulcerative colitis did not meet its primary endpoint of clinical remission compared to placebo. Both SER-109 and SER-287 are made from a purified consortium of Firmicutes spores derived from stool samples. According to the company’s website, the biotech is undertaking research to decide on the future of the ulcerative colitis program, which also includes another candidate called SER-301. Last year, Takeda Pharmaceutical ended its deal with Finch in August after a review of its pipeline. Previously, Takeda had licensed the two Finch treatments FIN-524 and FIN-525 for their development in IBD. Still, other companies are keen on exploring IBD further, such as the UK-based company Microbiotica. The start-up expects to start its Phase Ib in ulcerative colitis this year, and focuses on the development of orally administered live therapeutics that are derived from bacterial consortia. The potential use of microbiome therapeutics in cancer comes with its own set of questions. While humans normally encounter microorganisms in their day-to-day activities, their functioning immune systems can handle those, says Hota. But since the immunity of cancer patients is suppressed by treatments like chemotherapy, the risks here are much greater, she explains. Microbiome therapeutics here could be used as adjunct treatments, rather than primary therapies, says Dr. Louis Korman, co-director of Chevy Chase Clinical Research, Chevy Chase, Maryland. A lot of immunotherapies cause side effects in the gastrointestinal tract, says Korman. With that in mind, therapeutics could be used to reduce toxicity, he explains. Although enthusiasm for microbiome therapeutics is broadly quite high, it is slightly waning at expert meetings, says McGill. There is some confusion from the side of the investors due to the field’s broad nature, says Gilbert. This is further emphasised by the current state of the biotech market , he adds. But this could change with the first approvals, notes McGill. In a way, the accessibility could increase enthusiasm and interest, she adds. C,,, ,Ferring ,Rebyota,FDA-approved ,Seres,SER-109,PDUFA Date on April 26 , ,Vedanta,VE303 ,Phase III in 2023 ,Destiny,NTCD-M3 ,Phase III in 2023 ,Ferring ,MyBiotics,MBX-SD-202,Phase I completed in 2022 ,Adiso Therapeutics,ADS024,"Enrollment of Phase Ib complete, awaiting data, potentially ready for Phase II"Company,Product,Indication,Status AOBiome Therapeutics,B244,Pruritus,PhaseIIb complete enrollment AOBiome Therapeutics,B244,Acne,Phase IIb completed AOBiome Therapeutics,B244,Rosacea,Phase Iib completed Mikrobiomik,MBK-01,Nonalcoholic steatohepatitis,Phase II not yet recruiting Mikrobiomik,MBK-01,Klebsiella pneumoniae carpapenemase,Phase II recruiting Microbiotica,Live Bacterial Therapeutics ,Ulcerative colitis,Phase Ib start in 2023 Microbiotica,Live Bacterial Therapeutics ,Immuno-oncology,Phase Ib start in 2023

Phase 2Phase 3ImmunotherapyClinical ResultMicrobial therapy

09 Feb 2023

·www.biospace.com

Adiso Therapeutics Announces the Appointment of Srikar Guntaka, M.D., as Medical Director

CONCORD, Mass., Feb. 9, 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, has appointed Srikar Guntaka, M.D., as its Medical Director. In the newly created role, Dr. Guntaka will leverage his decade of medical affairs and clinical development experience to help Adiso progress its pipeline of novel, differentiated therapies for the treatment of inflammatory diseases. Most recently Dr. Srikar served as Medical Director, Clinical Development lead at Mirum Pharmaceuticals leading all aspects of global development for multiple indications of volixibat in adults. "We are excited to welcome Srikar during this critical period for the company and our pipeline," said Adiso CEO Scott Megaffin. "His therapeutic expertise in immunology and gastrointestinal diseases as well as his ability to execute later stage trials align well with our objective to advance ADS051 for ulcerative colitis and build on the excellent preclinical work for ADS032, a dual NLRP3/NLRP1 inflammasome inhibitor." "I am delighted to join Adiso, a dynamic company making significant progress in the advancement of locally acting multimodal therapies for inflammatory disease, that are more effective and potentially far less immunosuppressive than those currently available," said Dr. Guntaka. "The company's mission is centered on really listening to patients to improve their lives and those of their family members and this resonated with me as a healthcare provider." Dr. Guntaka has extensive experience in developing therapeutics for inflammatory diseases. Prior to Adiso and Mirum, he was Associate Medical Director, Gastroenterology (US Medical Affairs) at Abbvie where he provided strategic and operational input into core medical affairs activities. Before that, Dr. Guntaka was Sr. Manager, Clinical Development (LS&O) at Baxter Healthcare where he collaborated with medical affairs, pharmacovigilance, regulatory affairs and commercial organizations to drive clinical development programs. In addition, Dr. Guntaka is a published author of numerous papers and presentations. He received his M.D. from Sri Ramachandra Medical College & Research Institute. 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 of ulcerative colitis; 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 College Cork, Ireland, the APC Microbiome Institute, the University of Massachusetts Chan Medical School, the Hudson Institute of Medical Sciences Centre for Innate Immunity and Infectious Diseases in Australia and the University of Edinburgh Centre for Inflammation Research. 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

Executive Change

06 Oct 2022

·www.biospace.com

Adiso Therapeutics Provides Development Update Reflecting Strong Progress Across Its Pipeline

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

First in ClassSmall molecular drugFast Track

100 Deals associated with ART24

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Clostridium Infections	Phase 1	US	Artugen Therapeutics Ltd.	06 Mar 2020
Colitis, Ulcerative	Phase 1	US	Artugen Therapeutics Ltd.	06 Mar 2020
Colitis, Ulcerative	Phase 1	US	Adiso Therapeutics, Inc.	06 Mar 2020
Clostridium difficile infection	Phase 1	US	Adiso Therapeutics, Inc.	27 Feb 2020
Clostridium difficile infection	Phase 1	CA	Adiso Therapeutics, Inc.	27 Feb 2020

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ADS024 (ECTRIMS2023)	Not Applicable	-	-	Saline	sgcceaqmhx(crjecfxvvq) = shiutqydsr xifbcsnprj (prlyjklnpk )	-	30 Sep 2023
				ADS024 (5x108 CFU)	ubxomsrzfh(kcbwthytxg) = wyaauzscqa vxqmuwhnew (bvcpiglczc ) View more

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