Viva Biotech's portfolio companies have recently achieved significant milestones in clinical development across a range of therapeutic areas, including diabetes, gout, obesity, cancer, and stroke. These advancements highlight the ongoing innovation within the biopharmaceutical industry and the potential for new treatments to address unmet medical needs.
Seraxis' SR-02 for Type 1 Diabetes
Seraxis Inc. has received FDA clearance for its Investigational New Drug (IND) application for SR-02, a novel islet replacement therapy for Type 1 Diabetes. SR-02 is a stem cell-derived pancreatic product candidate and is the first of its kind to be approved by the FDA for human testing. The Phase I/II clinical study will evaluate SR-02's potential as a functional cure for insulin-requiring diabetes.
Arthrosi Therapeutics' AR882 for Gout
Arthrosi Therapeutics, in collaboration with ApicHope Pharmaceutical, has reported positive Phase II clinical trial results for AR882, a novel drug for treating primary gout with hyperuricemia. The trial's primary endpoint, the percentage of patients with serum uric acid levels below 360 μmol/L after eight weeks, was met with significant efficacy. By week six, the 75mg dose of AR882 demonstrated superiority over Febuxostat (P<0.001). AR882 also received FDA Fast Track Designation for Tophaceous Gout. The drug exhibited a favorable safety profile, with mild to moderate side effects such as diarrhea, headache, and upper respiratory infections. AR882 did not interfere with the management of patients' comorbidities, which remained stable throughout the trial.
Antag Therapeutics' AT-7687 for Obesity
Antag Therapeutics announced FDA clearance of its IND application for AT-7687, a Glucose-Dependent Insulinotropic Polypeptide (GIP) receptor antagonist. This allows Antag to commence a Phase I clinical trial to assess the safety, tolerability, and pharmacokinetics of AT-7687 in healthy lean and obese subjects. The study will also investigate AT-7687 as a monotherapy and in combination with semaglutide, a GLP-1 receptor agonist, in healthy obese individuals.
Cybrexa Therapeutics' CBX-12 for Ovarian Cancer
Cybrexa Therapeutics has dosed the first patient in a Phase 2 clinical trial of CBX-12 in patients with platinum-resistant or refractory ovarian cancer. CBX-12 is a first-in-class peptide-drug conjugate (PDC) that utilizes Cybrexa's alphalex™ technology to deliver exatecan, a topoisomerase 1 (TOP1) inhibitor, directly to tumor cells. Phase 1 results showed broad activity across various cancers, including ovarian, breast, non-small cell lung cancer (NSCLC), thymic, gallbladder, and colorectal cancers, with a manageable safety profile.
Basking Biosciences' BB-031 for Acute Ischemic Stroke
Basking Biosciences has dosed the first patients in a Phase 2 clinical trial (RAISE) evaluating BB-031 in patients presenting with acute ischemic stroke (AIS). BB-031 is a reversible thrombolytic designed for rapid-onset and short-acting activity, targeting von Willebrand Factor (vWF).
HAYA Therapeutics and Lilly Collaboration for Obesity and Metabolic Conditions
HAYA Therapeutics announced a collaboration with Eli Lilly and Company to discover novel regulatory genome targets for obesity and related metabolic conditions using HAYA's proprietary RNA platform. The agreement includes an upfront payment and potential milestone payments up to $1 billion, plus royalties on product sales.
