Revelyx Bio's YY003 Hits Phase 2 Endpoints in Glabellar Lines, Eyes FDA End-of-Phase-2 Meeting
核心洞察
Revelyx Bio (搜索) reported positive topline Phase 2 results for YY003, an investigational recombinant botulinum toxin type A supplied as a ready-to-use liquid, in moderate-to-severe glabellar lines (搜索).
The composite primary endpoint at Week 4 was met by 80.8% of participants receiving 40 U and 66.7% receiving 30 U, versus 0% for vehicle (p<0.001 for each dose).
No neutralizing antibodies were detected in any participant, and no treatment-related serious adverse events or discontinuations due to adverse events occurred.
Revelyx Bio (搜索), Inc. reported positive topline results from a Phase 2 clinical trial of YY003, an investigational recombinant botulinum toxin type A in a ready-to-use liquid formulation, in adults with moderate-to-severe glabellar lines (搜索). The trial met its primary endpoints and key secondary endpoints, according to the Nashville-based clinical-stage biopharmaceutical company, which announced the data on Sept. 14, 2026.
The two-part study (YY003-001-US01; NCT06481475) randomized 153 adults at three clinical sites in Australia under a U.S. Investigational New Drug application. Part A evaluated safety and tolerability across three dose levels. In Part B, 129 participants were randomized in a double-blind, vehicle-controlled evaluation of two doses — 30 U and 40 U — selected by an independent data monitoring committee.
The study's primary endpoints included safety and the composite response rate at Week 4, defined as the proportion of participants achieving a score of none or mild on the Facial Wrinkle Scale and at least a two-grade improvement from baseline, as assessed independently by both the investigator and the participant.
Efficacy Results
Composite response rates at Week 4 were 80.8% at 40 U and 66.7% at 30 U, compared with 0% for vehicle (p<0.001 for each dose versus vehicle).
Key secondary endpoints were also met. At Week 4, 92.3% of participants receiving 40 U achieved a score of none or mild on the Facial Wrinkle Scale as assessed by investigators (p<0.001 vs. vehicle). Onset was rapid: 90.4% of participants receiving 40 U achieved a score of none or mild by Week 1 — approaching the Week 4 result of 92.3% — compared with 3.8% for vehicle (p<0.001).
Additional secondary measures favored the 40 U dose. A total of 94.2% of participants receiving 40 U reported improvement on the Global Aesthetic Improvement Scale versus 0% for vehicle, and 90.4% reported satisfaction with the appearance of their frown lines versus 7.7% for vehicle.
"The data are compelling, particularly since the study incorporated a rigorous primary endpoint requiring both the investigator and the participant to independently record at least a two-grade improvement," said Professor Gregory Julian Randal Goodman, Director of Dermatology Institute of Victoria, President of Australasian Society of Cosmetic and Procedural Dermatologists, and principal investigator in the study. "YY003 has the potential to become the world's first ready-to-use liquid recombinant type A botulinum toxin. In addition to the encouraging efficacy and safety findings observed in this study, its liquid formulation may offer a practical benefit in the clinic by eliminating manual reconstitution and simplifying product preparation."
Safety and Immunogenicity
YY003 was generally safe and well tolerated. The most common treatment-related adverse events were injection-site reactions and headache. No treatment-related serious adverse events occurred, and there were no discontinuations due to adverse events in any group.
No neutralizing antibodies were detected in any participant. Only one of 106 evaluable participants (0.9%) tested positive for anti-drug antibodies while maintaining a clinical response.
Recombinant Manufacturing and Liquid Format
YY003 is produced using recombinant expression in E. coli rather than by purifying neurotoxin from cultures of Clostridium botulinum. The process is designed to provide control over the identity and purification of the expressed neurotoxin, and the resulting neurotoxin is structurally identical to the naturally derived protein, according to the company.
YY003 is supplied as a ready-to-use liquid, which removes the manual reconstitution step required for botulinum toxin type A products currently approved in the United States, which are supplied as lyophilized formulations requiring reconstitution. If approved, YY003 would be the first recombinant, pre-mixed alternative.
"These Phase 2 results provide encouraging clinical evidence for YY003 and are consistent with the profile we have seen across our recombinant platform," said Dr. Wu Yang, Chief Scientific Officer of Claruvis Pharmaceutical (搜索). "Recombinant BoNT/A provides a therapeutic protein with high purity through innovative design and a well-controlled manufacturing process. We look forward to working with Revelyx to advance YY003 into a Phase 3 clinical program."
Regulatory Next Steps
Revelyx plans to request an End-of-Phase-2 meeting with the U.S. Food and Drug Administration to discuss the proposed Phase 3 dose and pivotal-development program.
"These positive Phase 2 results mark an important milestone for YY003 and our partnership with Claruvis," said Dustin Sjuts, Chief Executive Officer of Revelyx Bio (搜索). "YY003 brings together recombinant technology and a liquid formulation in a way we believe could meaningfully advance innovation in the botulinum toxin category. Our next step is to request an End-of-Phase-2 meeting with the FDA to discuss the proposed Phase 3 dose and pivotal-development program."
Revelyx Bio (搜索) is a private, clinical-stage biopharmaceutical company developing and advancing differentiated therapies sourced from Asia-Pacific innovators for the United States and other global markets. Its lead program, YY003, is being developed for aesthetic and therapeutic indications, and Revelyx holds exclusive rights to develop and commercialize YY003 in all territories outside mainland China, Hong Kong, and Macau.
Claruvis, a subsidiary of MingMed Biotechnology (搜索), developed Retoxin (搜索) (YY001), described as the world's first approved recombinant botulinum toxin type A, and continues to advance a pipeline powered by its proprietary recombinant neurotoxin technology.
The company noted that results from this Phase 2 study are not necessarily predictive of results in subsequent studies or following repeat treatment, and that regulatory approval is not assured. YY003 is an investigational product and has not been approved by the FDA or any other regulatory authority.