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A few days ago, Forte Biosciences announced that the top-line data of the atopic dermatitis drug FB-401 in the phase 2 clinical trial failed to reach the primary trial endpoint
.
The company's CEO Paul Wagner said immediately that the future will not continue to promote the research and development of FB-401
The primary endpoint of this trial is to use the EASI measurement standard to improve the severity of patients with atopic dermatitis by at least 50%
.
The results of the trial showed that 58% of FB-401 subjects reached the primary endpoint of EASI-50, compared with 60% in the placebo group (p=0.
The FB-401 topical treatment agent contains three strains of Gram-negative bacteria, which Forte claims have potential therapeutic effects on inflammatory skin diseases (such as atopic dermatitis)
.
Forte previously conducted a Phase 1/2a study in children and adults, and the results showed that the therapy can significantly improve the patient's condition and itching symptoms, while also eliminating the need for steroid therapy
Regarding the failure of the trial, Wagner said, “Forte is grateful to the clinical trial sites and the patients who participated in this trial.
It also thanks Forte investors for taking risks to support the development of new treatments for atopic dermatitis, despite the top line of FB-401 The data is disappointing.
Forte will continue to analyze the test data; however, we will not continue to advance the research and development of FB-401, and hope to provide investors with the latest information on the company's future plans in the next few months
.
"
Previously, Citibank had stated that if Forte's drug FB-401 for the treatment of atopic dermatitis can become the standard of care for adults and children with mild atopic dermatitis, it is expected to account for 16 million mild to moderate atopic dermatitis patients in the United States4 % Of the market
.
If the FB-401 Phase II clinical trial is successful, the company may become a target for mergers and acquisitions in other pharmaceutical markets
According to a statement issued by the company, as of the end of June, Forte had $50.
8 million in cash and cash equivalents in the bank
.
The biotechnology company went public in February 2020 through the acquisition of Tocagen's all-stock exchange.
The representative drugs in the field of atopic dermatitis are from Sanofi and Regeneron Dupixent.
This is a chronic type 2 inflammatory disease.
More than 80% of patients are younger than 5 years old.
The symptoms include strong Persistent itching and skin lesions can cover most parts of the body, causing dryness, cracking, redness or darkening of the skin, crusting and bleeding, and increasing the risk of skin infections
.
Unlike the Forte trial, at the end of August, Sanofi and Regeneron announced that Dupixent had reached the primary endpoint and all of the primary endpoints in a pivotal phase 3 clinical trial for the treatment of children with moderate/severe atopic dermatitis (AD) from 6 months to 5 years of age.
Secondary endpoint
.
The data shows that at week 16, compared with standard treatment, the addition of prijuzumab to topical corticosteroids (TCS) significantly reduced the patient's overall disease severity and significantly improved the patient's skin Symptom clearance, itching, and health-related quality of life indicators
