Rani Therapeutics Holdings, Inc. (Nasdaq: RANI) announced today that it has entered into a research agreement with Chugai Pharmaceutical Co., Ltd. to evaluate the feasibility of applying Rani's oral delivery technology to Chugai's antibodies. The agreement, formalized on August 13, 2024, focuses on two molecules with undisclosed targets provided by Chugai.
Initial analysis has yielded promising results, with RaniPill® delivery demonstrating comparable bioavailability to subcutaneous injection for both molecules under investigation. This achievement represents a significant step forward in the quest to transform injectable biologics into oral medications.
"We are delighted to explore the opportunity of a collaboration with Chugai, a world-class industry leader with deep research and development capabilities and a reputation for bringing innovation to patients," said Talat Imran, Chief Executive Officer of Rani Therapeutics. "We believe Chugai's technology-driven drug discovery approach for innovation and development capabilities aligns seamlessly with Rani's expertise in developing oral antibodies, peptides, and large proteins with high bioavailability."
RaniPill® Technology Platform
The RaniPill® capsule represents a novel approach to oral biologics delivery, designed to replace subcutaneous injections or intravenous infusions with a more patient-friendly oral dosing regimen. Rani has built an impressive track record with this technology, having evaluated 19 diverse molecules in preclinical studies and completed three Phase 1 clinical trials, demonstrating the platform's versatility across various biologic types.
The technology addresses one of the pharmaceutical industry's most persistent challenges: delivering large, complex biological molecules orally while maintaining their efficacy. Traditional oral administration of biologics has been limited by degradation in the digestive tract and poor absorption through the intestinal wall.
Strategic Significance for Both Companies
For Chugai, known for its proprietary antibody engineering technologies, this collaboration offers a potential pathway to differentiate its therapeutic antibodies in the competitive biologics market. Oral administration could significantly enhance patient compliance and quality of life compared to injectable formulations.
"At Chugai, we are committed to developing innovative drug discovery technologies based on our technology-driven approach. We are honored to have the opportunity to evaluate Rani's technology, which proposes a pioneering and innovative approach that may potentially unlock significant value across multiple programs," said Tom Igawa, PhD, Head of Research of Chugai Pharmaceutical Co., Ltd.
Market Context and Potential Impact
The partnership comes at a time when the biologics market continues to expand rapidly, with antibody therapies representing a substantial portion of new drug approvals and pharmaceutical revenue. However, the requirement for injection or infusion remains a significant limitation for these therapies.
If successful, the application of RaniPill® technology to Chugai's antibodies could represent a paradigm shift in how these medications are administered, potentially expanding their use and improving treatment adherence. The oral delivery of antibodies could be particularly valuable for chronic conditions requiring long-term therapy.
Next Steps
While specific financial terms of the agreement were not disclosed, the research collaboration will focus on further evaluating the technical feasibility and optimization of the oral delivery system for Chugai's antibodies. Both companies will likely assess factors such as stability, bioavailability, and pharmacokinetic profiles before determining potential pathways for clinical development.
This partnership adds to Rani's growing portfolio of collaborations aimed at expanding the application of its RaniPill® technology across different therapeutic areas and molecule types, further validating the platform's potential to transform biologic drug delivery.
