Teva Pharmaceutical Industries has initiated investigational new drug (IND)-enabling studies for BD9, a novel dual-specific multibody designed to simultaneously target TSLP (Thymic stromal lymphopoietin) and IL-13 for the treatment of TH2-driven inflammatory diseases including atopic dermatitis and asthma. The development represents a strategic milestone in Teva's efforts to address unmet medical needs in inflammatory conditions where current treatments fall short.
Dual-Target Approach for Enhanced Efficacy
BD9 operates by simultaneously blocking IL-13 and TSLP, two key drivers of TH2-driven inflammation. This dual-targeting mechanism has the potential to improve treatment outcomes for patients with conditions such as atopic dermatitis and asthma, where existing therapies do not fully meet patient needs. The multibody was developed using Biolojic Design's computational biology and artificial intelligence platform, which generates antibodies capable of addressing multiple disease targets.
"With the initiation of IND-enabling studies we take a vital step toward delivering innovative treatments to patients who need them most," said Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. "This pre-clinical progress underscores Teva's commitment to accelerating innovation and to improving health outcomes and access to underserved patient populations."
Partnership and Development Strategy
Under the terms of their exclusive licensing agreement, Teva is responsible for the global development of BD9, while Biolojic Design is eligible to receive milestone payments based on the achievement of predefined pre-clinical, clinical, regulatory, and commercial targets. This collaboration aligns with Teva's broader Pivot to Growth strategy to accelerate innovation in its pipeline.
Yanay Ofran, PhD, CEO and founder of Biolojic Design, highlighted the platform's success: "Biolojic's next generation antibody platform has now produced four antibodies that are in, or nearing, the clinic. From the clinical data we have recently seen, it is already clear that our precision antibodies have distinct advantages over traditional antibodies, extracting better efficacy and safety from complex biological targets."
Additional FDA Fast Track Designation
In a separate regulatory development, the US Food and Drug Administration (FDA) has granted fast track designation to Teva's TEV-53408, an investigational anti-IL-15 antibody intended for the treatment of celiac disease in individuals adhering to a gluten-free diet. The FDA's Fast Track designation is designed to expedite the development and review of drugs that treat serious conditions and fulfill unmet medical needs. A phase IIa study is currently evaluating the safety and efficacy of TEV-53408 for treating adults with celiac disease.
Market Response and Pipeline Progress
Following the announcement of the BD9 development milestone, Teva shares rose 4.4% on May 27. However, year-to-date, Teva shares have declined 19.6% compared with the industry's decline of 15.8%. The company continues to advance its innovative pipeline, which focuses primarily on neuroscience and immunology therapeutic areas.
The initiation of IND-enabling studies for BD9 marks a critical milestone in translating scientific innovation into a potential therapeutic option, paving the way for clinical trials and ultimately bringing hope to underserved patient populations with inflammatory diseases.
