Taifeier Biopharmaceuticals announces the enrollment of the first patient of X0002, and the Phase III clinical trial is in full swing in the United States

Taifeier Biopharmaceuticals (Suzhou) Co.
, Ltd.
(hereinafter referred to as Taifeier) recently announced that its self-developed new molecular entity drug X0002 project has initiated Phase III clinical trials in the United States (ClinicalTrials.
gov, NCT03081806) and has completed its first trial The patients were included in the group medication
.

The study was led by Dr.
Thomas Schnitzer, a professor at Northwestern University, and carried out a multicenter, randomized, double-blind, placebo-controlled phase III clinical study for patients with knee osteoarthritis in 33 hospitals in the United States
.

Dr.
Marc Uknis, chief medical officer of Taifeier, said that osteoarthritis is a disease with high incidence and high disability
.

So far, there is no therapy that can prevent the progression of the disease.
The current painkillers have very limited analgesic effects, and have gastrointestinal and cardiovascular side effects.
They cannot be used for a long time.
There are important unmet medical needs in this field
.

Phase II clinical studies in the United States and China show that X0002 is significantly better than clinical drugs in improving WOMAC pain, improving arthritis disease status and safety in patients with osteoarthritis, and has the potential to treat osteoarthritis
.

The project can overcome the impact of the new crown epidemic in the United States, quickly start, promote and join the group, thanks to the strong support of Professor Thomas Schnitzer, Premier Research and various suppliers.
Thank you for the joint efforts of the project team! About X0002X0002 has strong tissue penetration ability, can quickly penetrate into articular cartilage and tissues after administration, can reach low blood concentration (low side effects) and high target tissue concentration (high curative effect), and can effectively improve and eliminate cartilage and tissue Inflammation, prevents cartilage calcification, and relieves joint pain and stiffness in patients with osteoarthritis
.

X0002 completed Phase I and Phase II clinical studies in the United States and China, and the results showed that its efficacy was dose-related.
It reached statistical significance in WOMAC (VAS) pain, stiffness, functional scale score and total score.
X-ray imaging Studies have shown that X0002 can increase the joint spacing of patients
.

X0002 has excellent safety.
The common gastrointestinal bleeding, irritation, liver and kidney dysfunction, and cardiovascular disease risks that are common in clinical use of drugs in patients with osteoarthritis have not been observed in the clinical studies of X0002
.

X0002 is expected to be an effective and safe drug that can be taken for a long time by patients with osteoarthritis
.

 About Taifeier Taifeier is a leading clinical stage new drug research and development company, dedicated to the research and development of original small molecule new drugs with independent intellectual property rights
.

The company has product layouts in the fields of inflammatory diseases, autoimmune diseases, cardiovascular diseases, metabolic diseases and depression
.

The first drug candidate X0002 has obtained the FDA "rapid review" qualification.
Osteoarthritis (OA) and lumbar arthritis indications have entered the third phase of clinical trials in the United States, and the third phase of clinical trials for OA indications in China
.

The new drug TF0023 is also conducting Phase II clinical studies in Europe and the United States
.

In the first half of this year, the company completed the B round of financing led by Guoke Investment, followed by well-known investment institutions such as Su Gaoxin Venture Capital, Tasly Capital, Qianhai Great Wall Fund, and Junchuan Capital
.

At the same time, the company's clinical management team is also joined by Chief Medical Officer Dr.
Marc Uknis, and it is basically formed this year
.

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