URAT1

HONG KONG, Oct. 30, 2024 /PRNewswire/ -- Even with the ever-changing situation, technological innovation is still the most critical component for biopharmaceutical companies' long-term development. This continuous innovation keeps companies up to date and promotes the evolution of R&D and the success of commercialization. Recently, Viva Biotech's portfolio companies have new updates. Keep reading for more details. Seraxis Announces FDA IND Allowance for Clinical Study of SR-02 Replacement Islets for Type 1 Diabetes October 15, 2024, Germantown, MD. Seraxis Inc., a clinical stage regenerative medicine company invested by Viva BioInnovator (VBI), has received FDA's allowance of an Investigational New Drug (IND) application for a Phase I/II clinical study of its novel islet replacement therapy SR-02. SR-02 is the first reprogrammed stem cell-derived pancreatic product candidate allowed by FDA for testing in humans as a potential functional cure for insulin-requiring diabetes. Arthrosi Therapeutics and ApicHope Pharmaceutical Co-developed Gout Treatment AR882 Achieves Promising Phase II Clinical Results in China and Granted Fast Track Designation by the FDA According to ApicHope Pharmaceutical, Arthrosi Therapeutics, Inc. ("Arthrosi"), a portfolio company incubated by Viva Biotech, has achieved outstanding results in a Phase II clinical trial for the investigational gout treatment AR882. Developed in collaboration with ApicHope Pharmaceutical, this Class I novel drug showed promising outcomes for treating primary gout with hyperuricemia and has now entered Phase II clinical trials in China. The Phase II clinical trial primarily aimed to explore the optimal dosing of AR882 capsules for treating primary gout with hyperuricemia and to preliminarily assess the drug's efficacy and safety. The primary endpoint was the percentage of patients with serum uric acid levels below 360 μmol/L after eight weeks of treatment. By week six, AR882 demonstrated significant efficacy, with the 75mg dose of AR882 showing superiority over Febuxostat (P<0.001). AR882 exhibited an excellent safety profile, with no severe adverse events reported. Mild to moderate side effects observed included diarrhea, headache, and upper respiratory infections. Importantly, AR882 did not interfere with the management of patients' comorbidities, which remained stable throughout the trial. On August 19, Arthrosi Therapeutics announced that it received FDA Fast Track Designation for AR882 in Tophaceous Gout. Antag Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for Lead Molecule, AT-7687 Copenhagen, Denmark – October 9, 2024 – Antag Therapeutics, a leading biopharmaceutical company focused on targeting the Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor to pioneer novel treatments for obesity and invested and incubated by Viva BioInnovator (VBI), announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for its lead molecule, AT-7687. This milestone enables Antag Therapeutics to initiate its Phase I clinical trial, which will evaluate the safety, tolerability, and pharmacokinetics of AT-7687 in both healthy lean and healthy obese subjects. The study will also explore AT-7687 as a monotherapy and in combination with semaglutide, a GLP-1 receptor agonist, in healthy obese individuals. Cybrexa Therapeutics Announces First Patient Dosed with First-in-Class Peptide-Drug Conjugate CBX-12 in Phase 2 Trial in Ovarian Cancer NEW HAVEN, Conn. – October 7, 2024 – Cybrexa Therapeutics, invested and incubated by Viva BioInnovator (VBI), a clinical-stage oncology biotechnology company developing a novel class of tumor-targeting peptide-drug conjugate (PDC) therapeutics, announced that the first patient has been dosed in a Phase 2 clinical trial evaluating CBX-12 in patients with platinum-resistant or refractory ovarian cancer. CBX-12 is a first-in-class PDC that uses Cybrexa's proprietary alphalex™ technology to enhance the delivery of exatecan, a potent, established topoisomerase 1 (TOP1) inhibitor, directly to tumor cells while sparing healthy tissue. This trial initiation follows promising Phase 1 results, which demonstrated CBX-12's broad activity across ovarian, breast, non-small cell lung cancer (NSCLC), thymic, gallbladder, and colorectal cancers, along with a manageable safety profile. Basking Biosciences Doses First Patients in Phase 2 Clinical Trial of Reversible Thrombolytic BB-031 for Acute Ischemic Stroke Columbus, Ohio – Sept. 10, 2024 – Basking Biosciences (Basking), invested and incubated by Viva BioInnovator (VBI), a clinical-stage biopharmaceutical company developing a novel acute thrombolytic therapy, announced that the first patients have been dosed in RAISE, a Phase 2 clinical trial evaluating BB-031 in patients presenting with acute ischemic stroke (AIS). HAYA Therapeutics Announces Collaboration with Lilly to Discover Novel Regulatory Genome Targets for Obesity and Related Metabolic Conditions Using Proprietary RNA Platform LAUSANNE, Switzerland & SAN DIEGO, HAYA Therapeutics, SA, invested and incubated by Viva BioInnovator (VBI), a biotechnology company pioneering precision RNA-guided regulatory genome targeting therapeutics for chronic diseases, announced a multi-year agreement with Eli Lilly and Company to apply HAYA's advanced RNA-guided regulatory genome platform to support preclinical drug discovery efforts in obesity and related metabolic conditions. The partners will identify multiple regulatory genome derived RNA-based drug targets to address these chronic conditions. Under the terms of the collaboration, HAYA will receive an upfront payment, including an equity investment, and is eligible to receive up to an aggregate $1 billion in pre-clinical, clinical and commercial milestone payments, as well as royalties on product sales. About Seraxis Seraxis is bringing transformative therapies to the millions of people worldwide struggling with the management of insulin-requiring diabetes and the associated life-threatening complications. Seraxis' lead program, SR-02, is a novel islet replacement therapy for patients of insulin-requiring diabetes with concurrent immunosuppression therapy. This therapy is the foundation of Seraxis follow-on therapies for patients without immune suppression. Frazier Life Sciences, Polaris Partners, Eli Lilly and Company, the T1D Fund and others are investors in Seraxis. Visit . About Arthrosi Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing AR882, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout. In the U.S., an estimated 13 million individuals are diagnosed with gout and approximately 2 million of those patients have visible tophi. In Phase II studies, AR882 demonstrated encouraging efficacy and safety compared to standard of care (SOC), while Phase IIb results showed impressive success in the complete elimination of tophi. Arthrosi is currently advancing AR882 into Phase III clinical trials. About Antag Therapeutics Antag Therapeutics is a clinical-stage biopharmaceutical company committed to discovering and developing novel therapies for obesity and cardiometabolic diseases through GIP receptor antagonism. As a pioneer in exploring the potential of GIP receptor antagonists, the company is dedicated to advancing science and improving patient outcomes by delivering groundbreaking solutions that address unmet medical needs. For more information, please visit . About Cybrexa Therapeutics Cybrexa is a privately held clinical-stage biotechnology company pioneering novel antigen-independent, tumor-targeting peptide-drug conjugate (PDC) therapeutics. The company is led by a dynamic team of highly successful life science entrepreneurs and veteran drug development scientists. Cybrexa is on a mission to create therapeutics that revolutionize the standard of care in oncology, and its robust pipeline aims to combat breast, ovarian, non-small cell lung cancer, and a range of other tumors. Its assets are built on Cybrexa's alphalex™ technology platform, which enables intracellular delivery of highly potent anti-cancer treatments. Cybrexa is based in New Haven, Connecticut and was founded in 2017. For more information, please visit or follow us on LinkedIn and X. About Basking Biosciences Basking Biosciences, a clinical-stage biopharmaceutical company, was founded to solve the biggest need in acute thrombosis – for a rapid-onset, short-acting thrombolytic drug capable of reopening blocked arteries, and whose activity can be quickly reversed in the event of a bleeding complication. Leveraging RNA aptamer technology, our lead drug candidate, BB-031, targets von Willebrand Factor (vWF), an important structural component of blood clots and driver of the clotting process, and is designed to be safer, more effective, and able to significantly expand the population receiving acute revascularization therapy. About HAYA Therapeutics HAYA Therapeutics is a precision medicines company developing programmable therapeutics targeting regulatory RNAs derived from the dark genome, a cell information processing unit, to reprogram pathological cell states for a broad range of diseases, including cardiovascular and metabolic diseases and cancer. The company is using its innovative platform to gain novel insights into the biology of disease cell states and the long non-coding RNAs (lncRNAs) that regulate them. HAYA's lead therapeutic candidate is HTX-001, in development for the treatment of heart failure. HAYA is also developing a pipeline of lncRNA-targeting precision therapies for the cell-specific treatment of diseases in other tissues. SOURCE Viva Biotech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

—AR882 demonstrated safe and efficacious long-term reduction of serum urate (sUA) levels and elimination of urate crystal deposition in a sub-analysis of gout patients from the Asia-Pacific region— SAN DIEGO, Calif., Aug. 23, 2024 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout, today announced additional positive data from a sub-population analysis for its Phase 2 clinical program in gout patients from the Asia-Pacific region. These data are being presented as a poster at the 26th Asia-Pacific League of Associations for Rheumatology Congress, being held August 21-25 in Suntec, Singapore. "We are excited to present new sub-population data from our previously reported positive Phase 2 clinical program for AR882 at APLAR as there remains a significant unmet need for patients suffering from gout worldwide," said Robert T. Keenan, MD, MPH, MBA, Chief Medical Officer at Arthrosi Therapeutics. "The data to be showcased further reinforces AR882's potential to drive robust, durable sUA and tophi reduction, while achieving an improved safety profile compared to existing standard of care to date. Most notably, 83% of patients who received 75mg of AR882 achieved serum urate levels below 5 mg/dL, which is essential for resolving debilitating tophi, crystal burden and flares. We look forward to continuing to evaluate AR882 in our pivotal Phase 3 REDUCE 2 study, initiated in June, and we expect to initiate a second confirmatory Phase 3 study in the second half of this year." Clinical Data for AR882, Arthrosi's URAT1 Inhibitor In a poster presentation, Dr. Keenan will highlight sub-group data from the company's Phase 2 program that demonstrates that long-term administration of AR882 is safe and efficacious in reducing sUA and eliminating urate crystal deposition in 68 gout patients from Australia, New Zealand and Taiwan. 53 of these patients were enrolled in the Phase 2 gout study and randomized equally into three treatment groups to receive once-daily AR882 50 mg, AR882 75 mg, or placebo for 3 months. The other 15 patients were enrolled in the Phase 2b subcutaneous tophi study and received once-daily AR882 75 mg, AR882 50 mg in combination with allopurinol 300 mg for 12 months, or allopurinol 300 mg for 6 months then in combination with AR882 75 mg for 6 months. Serum urate levels were measured at 3, 6 and 12-month visits. In the subcutaneous tophi study, caliper measurements and dual energy computed tomography (DECT) were performed at baseline, months 6 and 12. Safety assessments were collected throughout the study. The data showed: AR882 75 mg and the AR882 50 mg + allopurinol groups demonstrated a substantial and durable decrease in sUA through 3, 6 and 12 months. The pooled mean baseline sUA level was 8.7 mg/dL. At the 3-month visit, median sUA levels were 4.9 and 3.4 mg/dL for AR882 50 mg and AR882 75 mg, respectively, corresponding to a 43.3% and 63.7% reduction. 92% and 83% of the patients achieved sUA < 6 and <5 mg/dL, respectively, when taking AR882 75 mg as a monotherapy. Patients receiving AR882 monotherapy or AR882 in combination with allopurinol showed greater sUA response than allopurinol alone. DECT urate crystal volume was reduced by 50% in the AR882 75 mg group after 6 months of treatment versus 25% in the allopurinol group. AR882 was well tolerated. The most frequently reported adverse event was gout flare, which appeared less often in AR882 groups compared to controls. Details for the poster presentation is as follows: Title: Efficacy of AR882, a Selective Uric Acid Transporter 1 (URAT1) inhibitor in Gout Patients from the Asia-Pacific Region in Two Phase 2 Studies Presenting Author: Robert Keenan, M.D., Chief Medical Officer of Arthrosi Therapeutics Poster Number: 597 Date/Time: Friday, August 23 at 10:45-11:10am and 4:15-4:45pm SGT The poster presentation will be available in the "Publications" section of Arthrosi's website: . About the AR882-202 Phase 2b Study The Phase 2b study was a global, multicenter, 12-week, randomized, double-blind, placebo-controlled study of 140 gout patients who met the gout classification according to the American College of Rheumatology (ACR) and The European Alliance of Associations for Rheumatology (EULAR). The mean baseline serum urate (sUA) among the participants was 8.6 mg/dL. Patients who participated in the study had several major comorbidities, including hypertension (47%), hyperlipidemia (35%), renal insufficiency (34%), arthritis (23%), diabetes (19%), cardiovascular disease (15%), lung disease (11%), and liver disease (5%). In the study, patients received a daily dose of 50 mg AR882, 75 mg AR882, or matching placebo. The sUA levels (< 6, <5, <4, or <3 mg/dL) were evaluated following 12 weeks of dosing, and safety and tolerability were assessed throughout the study. About the AR882-203 Phase 2 Study The Phase 2 study of AR882 in patients with tophaceous gout was a six-month, 1:1:1 randomized, global, placebo-controlled study of 42 patients with subcutaneous tophi. The mean baseline sUA among the participants ranged between 9.1-9.6 mg/dL. In the study, patients received a once daily dose of either 75 mg AR882, 50mg AR882 + allopurinol, or allopurinol up to 300mg. Serum uric acid levels (< 6, <5, <4, or <3 mg/dL) were evaluated monthly through month 6, and safety and tolerability were assessed throughout the study. Tophi measurements with calipers were completed every 4 weeks for 6 months. Patients were also imaged using Dual-Energy Computed Tomography (DECT), DECT a specialized imaging technique that is able to differentiate and identify uric acid crystals in the joints and soft tissue, allowing for quantifying uric acid crystals and tophi at baseline and 6 months. The primary efficacy endpoint was sUA change at 3 months. Secondary endpoints included complete resolution of at least one target tophus with no new tophi and no tophus showing progression. Safety assessments, including vital signs and electrocardiograms, were collected throughout the study. The trial also included a 6-month extension period designed to evaluate longer-term patient outcomes. About Gout: In the U.S., an estimated 13 million individuals are diagnosed with gout. Gout is a form of inflammatory arthritis that can significantly diminish mobility, functionality, and overall quality of life. Gout emerges from the crystallization of uric acid within the joints and soft tissue, instigating painful flare-ups and chronic symptoms. The kidneys play a pivotal role in the process, as they are responsible for filtering out and excreting uric acid from the body. In over 90% of gout patients, underexcretion of uric acid results in the imbalanced and elevated sUA levels that can lead to the deposition of uric acid crystals. It's essential to monitor and manage sUA levels as part of comprehensive gout treatment and prevention strategies. About Arthrosi: Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing AR882, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout. Gout remains a large and growing market with ~ 13M patients in the U.S. alone, ~2M of which have tophaceous gout. AR882 has demonstrated encouraging efficacy and safety compared to SOC in Phase 2 studies as well as impressive results in achieving complete resolution of tophi in a Phase 2b study. Arthrosi is currently advancing AR882 in a pivotal Phase 3 program. Media Contact: Shunqi Yan, PhD Founder & Chief Operating Officer [email protected] Investor Contact: Precision AQ Alex Lobo 212-698-8802 [email protected] SOURCE Arthrosi Therapeutics

SAN DIEGO, Aug. 19, 2024 /PRNewswire/ -- Arthrosi Therapeutics, Inc., a late-stage biotechnology company developing a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to treat gout, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to AR882 for the potential treatment of clinically visible tophi in patients with gout. "Receiving Fast Track designation for AR882 from the FDA marks a significant milestone for Arthrosi. This highlights the FDA's recognition of the serious and disabling nature of gout in patients with clinically visible tophi and the potential of AR882 to meet this critical medical need," said Litain Yeh, Ph.D. Founder and CEO of Arthrosi Therapeutics. "With our pivotal Phase 3 clinical program underway, we are committed to working closely with the FDA to accelerate the development of AR882." Fast Track Designation is a process designed to facilitate development and expedite the review of drugs intended to treat serious conditions and fill an unmet medical need. About Gout: In the U.S., an estimated 13 million individuals are diagnosed with gout and approximately 2 million of those patients have visible tophi. Gout is a form of inflammatory arthritis that can significantly diminish mobility, functionality, and overall quality of life. Gout emerges from the crystallization of uric acid within the joints and soft tissue, instigating painful flare-ups and chronic symptoms. The kidneys play a pivotal role in the process, as they are responsible for filtering out and excreting uric acid from the body. In over 90% of gout patients, underexcretion of uric acid results in the imbalanced and elevated sUA levels that can lead to the deposition of uric acid crystals. It's essential to monitor and manage sUA levels as part of comprehensive gout treatment and prevention strategies. About Arthrosi: Arthrosi Therapeutics, Inc., headquartered in San Diego, CA, is focused on developing AR882, a potentially best-in-class, highly potent and selective next generation URAT1 inhibitor to reduce serum urate levels, flares and tophi in patients with gout. AR882 has demonstrated encouraging efficacy and tolerability across a total of nine clinical studies including in patients with renal impairment and tophaceous gout. The Company is currently advancing AR882 in a pivotal Phase 3 program and has been granted Fast Track Designation from the U.S. FDA for patients with clinically visible tophaceous gout. Media Contact: Shunqi Yan, PhD Founder & Chief Operating Officer [email protected] Investor Contact: Precision AQ Alex Lobo 212-698-8802 [email protected] SOURCE Arthrosi Therapeutics