Tyfil Biopharma announces the completion of the X0002 US Phase III clinical trial to recruit and enroll subjects

Taifeier Biomedical (Suzhou) Co.
, Ltd.
(hereinafter referred to as Taifeil) recently announced that its self-developed new molecular entity drug X0002 project in the United States Phase III clinical study has recently completed the recruitment of
subjects.
The study, led by Dr.
Thomas Schnitzer, a professor at Northwestern University, conducted a multicenter, randomized, double-blind, phase III clinical study
in patients with knee arthritis in 33 hospitals in the United States 。 The project completed the first case of subject enrollment in October 2021, lasted about a year, overcame the impact of the new crown epidemic in the United States, and finally successfully completed the recruitment and enrollment of subjects, and the clinical data after blindness can be obtained in the first half of next year, thanks to the strong support of Professor Thomas Schnitzer, Premier Research and various suppliers, thanks to the joint efforts of the project team!

Dr.
Yu Chongxi, the founder of Taifeil, said that X0002's outstanding tissue penetration ability can quickly penetrate into joint cartilage and tissues after administration to achieve high target tissue concentration to improve efficacy and maintain low blood concentration to avoid side effects
。 The phase III design combines a 22-week randomized double-blind efficacy study and a 52-week safety study into one (22-week randomized double-blind and 30-week open-label study), and all patients in the 30-week open-label study use the study drug, and the efficacy results show that X0002 is far superior to the first-line drug currently used in clinical use, not only can achieve a painless state, but also maintain the efficacy after 4 weeks of withdrawal, which is unprecedented
.
To date, no systemic adverse effects related to the drug have been observed, which is also unprecedented
.
The study doctors of the clinical center with more than 5 patients praised the high efficacy and safety of X0002 to our clinical team, and conveyed the patient's praise for X0002: "X0002 allows me to return to my normal life", "This is an incredibly effective drug without any bad feelings", "My joints are completely painless, my life is completely normal", "I am looking forward to this drug being approved, and I will never use any other drugs again"," This drug is too efficient and easy to use", and many patients asked doctors if they could continue to use X0002
after the end of the clinic.

About X0002

X0002 has strong tissue penetration ability, can quickly penetrate into joint cartilage and tissues after administration, can achieve low blood concentration (low side effects) and high target tissue concentration (high efficacy), can effectively improve and eliminate cartilage and tissue inflammation, prevent cartilage calcification, reduce osteoarthritis patients with joint pain, stiffness and other symptoms
。 Since the US new drug market accounts for most of the global market, the profit of new drugs in the US market is more than 2/3 of the global profit, for this X0002 in the United States to conduct a separate clinical study to ensure clinical quality, but also in China separate phase I and phase II clinical studies, clinical results show that X0002 has excellent efficacy and safety, China clinical phase III study has completed patient enrollment at the end of September this year, is expected to complete clinical research
in February next year 。 X0002 not only has a high efficacy, gastrointestinal and gastrointestinal bleeding, irritation, liver and kidney dysfunction, and cardiovascular disease risks common in patients with osteoarthritis have not been observed
in X0002's clinical studies.
X0002 is expected to become a long-term, effective and safe drug
for patients with osteoarthritis.