RJV001 is being developed as an injectable biologic to reduce submental fat, thus providing a non-invasive alternative for patients troubled by the problem. Once approved, RJV001 may surpass the conventional liposuction surgeries to minimize surgical trauma, reduce medical cost and shorten recovery. RJV001 received the approval of Food and Drug Administration (FDA) Investigational New Drug (IND) of Phase I Clinical Trial (PH1) on Dec 20, 2020. In the first quarter of 2021, the first in human (FIH) study of RJV001 has started and registered on https://clinicaltrials.gov/ (NCT04821648). The clinical study report was submitted to US FDA on 13 May 2022 and approved.
- Phase I Clinical Trial -
The phase I clinical trial of mutant collagenase injection for subcutaneous fat reduction was completed at Arizona Research Center, US (NCT04821648). The clinical study report was submitted to US FDA on 13 May 2022 and approved.
18 subjects reached EOS*, 100% female, and 77.8% Caucasian.
Tested doses were well-tolerated in all Cohorts (0.04, 0.075, 0.15 mg/injection, up to 30 injection sites).
Bruising and tenderness to palpation were mostly appeared local skin reactions and resolved within 30 days, mild to moderate (grad 1 -2).
No clinical significance change found in laboratory tests.
AEs* were expected and recovered, no SAEs*
Evidence of fat reduction obtained from ultrasound examination
Fibrosis noted in 10/12(83%) patients in Cohort B/C, may help in “skin laxity”after fat reduction.
- Phase II Clinical Trial -
EOPI and Phase II clinical trial is in preparation.
Completed preclinical studies include:
- CMC -
RJV001 is prepared by E.Coli fermentation process. The protein purity was about 99.5%, and PCB, MCB, WCB were established. The stability test results under various factors (temperature, ion, repeated freezing and thawing, etc.) were all good in three batches of pilot scale production.
- Product Validation -
RJV001 is a mutated collagenase, so it has been tested several times. The experimental report shows that the results are in line with the expected structure after mutation. The relevant experimental data were used to US FDA IND application and was approved.
- Efficacy Studies -
The mutant collagenase RJV001 was validated in various animal models (rat, Bama pig, etc.). The data were used to US FDA IND application and was approved.
- Safety Evaluation -
The PK Kit was completed and validated in both rat (rodent) and minipig (non-rodent) species. were used to US FDA IND application and was approved.