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The China study confirms a Phase 2a trial in Australia demonstrating ABP-671 significantly reduces serum uric acid levels and is well tolerated JIANGSU, China--(BUSINESS WIRE)-- Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.), a clinical stage biotechnology company developing best in class treatments for inflammatory and metabolic diseases, announced today positive results from its China Phase 2a clinical trial of ABP-671. The randomized, double-blind, placebo-controlled trial enrolled 54 patients with gout or hyperuricemia across six cohorts, with 7 randomized to ABP-671 and 2 to placebo per cohort. The study successfully reached its main endpoints. At a dose of 1 mg ABP-671 once daily (QD), 86% of patients reached serum uric acid (sUA) levels below 6 mg/dL. Furthermore, 100% of patients achieved sUA levels below 6 mg/dL in multiple higher tested doses. At doses of 6 mg and 12 mg ABP-671 QD, 100% of patients saw their sUA levels drop below 5 mg/dL, and 57% and 100% respectively achieved sUA levels below 4 mg/dL. Importantly, all doses were well tolerated and no significant safety concerns were observed. "The results from our Phase 2a clinical trial in China are consistent with the findings from our Phase 2a trial in Australia, indicating that ABP-671 can effectively reduce uric acid levels significantly and safely compared to currently marketed gout drugs, which have been associated with serious adverse side effects," said Dr. William Shi, CEO and Chairman of Atom Bioscience. "The consistency of these positive results from our back-to-back clinical trials is encouraging, and we look forward to advancing ABP-671 into pivotal trials in the US and other countries later this year." The Phase 2a Australian study met its primary objective of lowering sUA levels to below 6 mg/dL and was well tolerated. The study in Australia enrolled 60 gout and hyperuricemia patients randomized to receive daily ABP-671 doses of 2 mg, 4 mg, 8 mg or placebo. Significantly, high proportions of patients who received the treatment experienced a reduction in sUA levels. Nearly 90% of patients receiving 4 mg QD experienced reduction of sUA levels below 6 mg/dL, while 100% and 88% of patients who received 8 mg saw sUA levels drop to < 5 mg/dL and < 4 mg/dL, respectively. The American College of Rheumatology recommends sUA levels below 6 mg/dL for the prevention of gout flares and long-term joint damage. The British Society of Rheumatology and the European Alliance of Associations for Rheumatology recommend a target sUA level of < 5 mg/dL for tophaceous gout. Current medications in the gout therapeutics market require much higher doses to control chronic gout and are generally accompanied by serious side effects, such as severe hepatotoxicity, nephrotoxicity, higher risk of sudden death, heart disease, or gastrointestinal discomfort. ABP-671 is a small molecule inhibitor of the urate transporter 1 (URAT1) protein, which is involved in the reabsorption of uric acid by the kidneys. In gout patients, ABP-671 reduces the reabsorption of uric acid, increasing its excretion in urine. About Atom Bioscience Atom Bioscience (Jiangsu Atom Bioscience and Pharmaceutical Co. Ltd.) is a fast-growing innovative drug company, focused on development of best in class small molecule therapeutics for treatment of inflammatory and metabolic diseases. The company’s lead product, ABP-671, is in late stage clinical development for treatment of chronic gout. For more information please visit: View source version on businesswire.com: Contacts Business Development Contact: Roy J. Wu, MBA Sr. Vice President, Business Development Atom Bioscience and Pharmaceutical Co., Ltd Email: roy.wu@atombp.com Source: Atom Bioscience View this news release online at:

Courtesy ThamKC/Getty Images Incidence of gout has increased globally during the past quarter-century, spurring the development of new, more effective therapies aimed at chronic gout. "Gout is the most common inflammatory arthritis in the world, and existing treatments rarely achieve target serum urate levels,” said Shunqi Yan, Ph.D., founder and chief operating officer of Arthrosi Therapeutics in an interview with BioSpace. “As patients continue to be undertreated with current therapies, monosodium urate crystals (called tophi) continue to accumulate in the joints and tendons, worsening flares, joint erosions and disability.” An aging, more sedentary population is one of the reasons for the uptick, along with purine-rich diets (such as red and organ meats, anchovies, sardines, mussels, scallops, trout and tuna, as well as alcoholic beverages and drinks high in fructose). Genetic associations may also be involved. These conditions each can cause uric acid levels to increase. Inhibiting and Degrading Uric Acid Scientists are exploring three broad ways to address this. The first tries to inhibit the production of uric acid, degrade it or enhance its ability to leave the body. “One category of treatments uses xanthine oxidase inhibitors, notably allopurinol, to reduce the production of uric acid in your body,” said Roy Wu, SVP of global business development for Atom Bioscience. Allopurinol is the standard of care, yet “Its efficacy is only about 40 to 45 percent,” Wu said. Its safety pro improvement, too. “It’s not very well tolerated, causing a skin reaction (Stevens-Johnson Syndrome) and GI problems. It also requires titration over a long period of time, which means doses can’t be adjusted rapidly," he noted. While a few companies are investigating iterations of xanthine oxidase inhibitors, a scan of ClinicalTrials.gov shows more activity focused on other approaches. Metabolizing Uric Acid Synlogic, for one, is working to metabolize uric acid in the GI tract with an engineered strain of a probiotic bacteria, said Dave Hava, Ph.D., chief scientific officer. “We hypothesize there is a significant gut component to uric acid metabolism – that uric acid can come from the diet through purine metabolism, but that it also could recirculate in the systemic circulation into the GI tract and be secreted back out, in a kind of loop. “We hypothesized that if we could design a bacteria that encounters uric acid in the GI tract, breaks it down into something non-toxic and prevents its reabsorption into systemic circulation, it could ultimately lower uric acid levels in the plasma,” Hava explained. Preclinical data from the prototype strain support that hypothesis. Non-human primate studies show the engineered strain Synlogic designed is active and can reduce systemic levels of uric acid. “We anticipate releasing more preclinical data on SYNB2081 later this year,” Hava said. Synlogic worked with Ginkgo Bioworks to design the prototype probiotic strain, essentially programming it to be effective under the conditions prevalent in gout. “Biology is fundamentally programmable,” said Patrick Boyle, Ph.D., head of Codebase, at Ginkgo Bioworks. “If you think about the substrate of biology that we’re engineering, we’re rewriting genetic code. Many of the same principles apply between digital code and software code. While biology is infinitely more complex than computer code, changing an A to a T affects how the cell reads that DNA code and changes its behavior.” Ginkgo used that approach with Synlogic to design organisms for a particular purpose. Another company, Allena Pharmaceuticals, has Fast Track designation for its orally-absorbed enzyme to treat gout and chronic kidney disease. When kidneys are impaired, uric acid is eliminated through the GI tract, so ALLN-346 degrades urate there in a way that prevents it from being absorbed systemically. Allena completed enrollment of a Phase IIa outpatient study 202 in July. Results have not been released. Urate Transporter 1 Inhibitors A third approach is to cause the system to excrete uric acid more efficiently. “About 85% of gout patients have a problem eliminating enough uric acid,” Yan said. A urate transporter 1 (URAT1) inhibitor, therefore, could fill a large unmet need. “There is an increasing body of evidence that URAT1 inhibitors may slow the progression of chronic kidney disease and also may have cardiovascular benefits,” he noted. To that end, Arthrosi is developing AR882 to normalize uric acid excretion through the kidney. This would reduce circulating levels of uric acid throughout the body as well as the formation of monosodium urate crystals. The goal is to reduce serum urate levels below the 6mg/dL needed for disease control and, ideally, below 5mg/dL. AR882 “has been shown to be well-tolerated in clinical trials…and is the only oral therapy evaluating the tophi reduction potential in a Phase II study,” Yan said. Arthrosi completed enrollment of more than 120 patients with chronic gout in a global Phase IIb study being conducted at 24 sites in the United States, Australia and Taiwan. The three-month study will evaluate dosage. In the earlier Phase IIa study, a 50 mg dose of AR882 reduced serum levels to below 5mg/dL in 93 percent of patients, whereas a 75 mg dose reduced levels below 4mg/dl in 88 percent of patients, suggesting it may also succeed in reducing flares. Atom Bioscience is also concentrating on uric acid excretion. “ABP-671 is a URAT1 inhibitor, which helps block the reabsorption of uric acid back into the body through the kidney and thus to excrete uric acid,” Wu said. “This is a more direct approach to reducing uric acid from the body than reducing its production.” Early studies showed a nearly 30 percent reduction in uric acid during the first day of treatment, which Wu called significant. Atom is finalizing the protocols for a Phase IIb/III study for chronic gout that likely will begin in 2023. It’s a six-month treatment and is expected to take six to nine months to enroll, so a readout in mid-2024 seems likely. Atom is thinking of ABP-671 as a possible first-line monotherapy, Wu said.

Life sciences and biopharma companies added new chief executive officers, chief medical officers and scientific officers to guide their companies into the future and oversee developmental programs. New CEOs Assembly Biosciences John G. McHutchison will retire as chief executive officer of Bay Area-based Assembly Biosciences at the end of this year. He will continue to serve on the company's board of directors. Taking over the reins is Jason A. Okazaki, the company's current president and chief operating officer. Okazaki joined Assembly Bio as chief legal and business officer in 2020. In 2021, he was promoted to chief operating officer. His duties included an expanded focus on investor relations, facilities and information technology. This year, he was elevated to president and became responsible for all general and administrative functions. Prior to joining Assembly Bio, Okazaki was senior vice president, legal and assistant secretary at Gilead Sciences, Inc., a company where he spent 14 years. Urica Therapeutics Jay D. Kranzler was appointed chairman and CEO of Urica Therapeutics, a subsidiary of Fortress Biotech. Kranzler will guide the development of the company's lead candidate, dotinurad, a potential best-in-class urate transporter inhibitor currently in Phase I clinical trials for gout. Kranzler has served in operational and consulting capacities for multiple pharmaceutical companies. He currently served as an adjunct professor at New York University Stern School of Business and at the New York University Langone School of Medicine. Kranzler previously served as global head of external R&D innovation and worldwide R&D strategic investments at Pfizer and was the CEO of Cytel Corporation. He is currently a board member of multiple companies. He sits on the boards of Avenue Therapeutics, Baergic Bio, Pastorus, Navitas and ImmunoBrain Checkpoint. Evaxion Biotech A/S Denmark-based Evaxion also named a new CEO. Per Norlén, a board-certified physician joined the company at the beginning of the month. He has served in executive leadership roles for life sciences companies across Europe. BlueSphere Bio Pittsburgh-based BlueSphere also named a new CEO. Chief Business Officer Keir Loiacono was tapped to take over the company's reins. The transition comes as BlueSphere aims to an IND for its first clinical candidate, a TCR T-cell therapy directed against the minor histocompatibility antigen HA-1 for the treatment of high-risk leukemia in the setting of allogeneic stem cell transplant. Before BlueSphere, Loiacano served as vice president of business development and general counsel of OncoSec Medical Inc. He also worked as a senior director for Advaxis, Inc. and before that, was an attorney with Lerner David Littenberg Krumholz & Mentlik. New Chief Medical Officers Celularity, Inc. Adrian Kilcoyne was appointed CMO and head of global medical affairs, patient safety and patient affairs of Celularity. Kilcoyne joins from Humanigen, where he also held the role of CMO. Before that, he was head of global oncology evidence generation and external alliances at AstraZeneca. Cerevance Ottavio V. Vitolo was named CMO of privately-held Cerevance. He will lead the company's global clinical development and regulatory operations. Vitolo recently served as CMO and global head of R&D at Alcyone Therapeutics. Prior to that role, Vitolo served as senior vice president, head of R&D and CMO at Relmada Therapeutics Inc. Earlier in his career, Vitolo was vice president of clinical development at Homology Medicines and held positions of increasing responsibilities at Pfizer. Vico Therapeutics Netherlands-based Vico has a new CMO. Scott Schobel joined the company as CMO after spending 10 years at Roche, where he led the development of small molecules, monoclonal antibodies, and antisense oligonucleotides. At Roche, Schobel was group medical director and, most recently, clinical science leader of the Roche tominersen and gantenerumab clinical development programs. Before Roche, Schobel was an assistant professor of clinical psychiatry at Columbia University Medical Center. Harpoon Therapeutics Luke Walker was named CMO of Bay Area-based Harpoon Therapeutics. He will lead the company's clinical development strategy. Walker joins Harpoon from Seagen, where he served as vice president of clinical development. He came to Seagen through that company's acquisition of Cascadian Therapeutics, where he led clinical development. New Chief Scientific Officers Evommune, Inc. Jeegar Patel was appointed CSO of Palo Alto-based Evommune. Patel recently served as SVP of research and nonclinical development at Kadmon Holdings, Inc., a Sanofi Company. Prior to joining Kadmon, Patel was a nonclinical development project leader at ImClone Systems, now an Eli Lilly company. Patel began his career as a nonclinical development project toxicologist at Abbott Laboratories and Aventis Maat Pharma Nathalie Corvaïa takes on the role of CSO at France-based Maat Pharma. She will oversee MaaT Pharma's non-clinical research and development strategies. Prior to joining MaaT Pharma, Corvaïa was the head of immuno-oncology research at The Pierre Fabre Immunology Center in France. LifeMine Therapeutics Martin Stahl was named CSO of LifeMine. Stahl joins LifeMine Therapeutics from Roche, where he held various scientific leadership roles over 25 years, including positions in medicinal chemistry, immunology, portfolio management and research technologies. Most recently, he served as global head of lead discovery, an organization comprising biophysics, biostructure, biochemistry, cell engineering, assay development and screening capabilities. Stahl will lead LifeMine's operations at its European offices in Basel, Switzerland. Additionally, the company named Louis Plamondon executive vice president and head of CMC. Plamondon was previously senior vice president and head of CMC at Constellation Pharmaceuticals.