Psoriasis topical new dosage form harvest positive 3 results

December 13, 2023

Psoriasis topical new dosage form harvest positive 3 results

August 23, 2018 Source: Sina Pharmaceutical News

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On August 21, MC2 Therapeutics, which focuses on topical treatments for skin diseases and eye diseases, published positive top-line data from the Phase 3 study of the MC2-01 emulsion. The MC2-01 study showed that it exceeded the control drug taclonex (external suspending agent) in terms of treatment success rate and convenience. The trial reached its primary and secondary destinations and the company has plans to submit an NDA application in the first half of 2019.

Main research endpoints:

The results of the study showed that MC2-01 cream had a better effect at 8 weeks of treatment (40.1% vs. 24.0%, compared to the Taclonex topical suspension), based on the physician's global assessment (PGA) score. p<0.0001). In other words, the trial reached its primary endpoint, demonstrating the non-inferiority of MC2-01 cream and taclonex.

Secondary study end point:

· For the percentage of mPASI from baseline to week 8, MC2-01 cream was superior to taclone (64.8% vs 52.3%, p < 0.0001). The MC2-01 cream showed rapid onset (p < 0.001) at week 1 and was superior to taclonex.

· MC2-01 cream is superior to taclonex in patient convenience (p<0.0001).

· MC2-01 cream is effective in reducing itching (60.2% at week 4) by an itching severity of 11 digital grades of grade 4 or higher.

· Adverse reactions observed in the trial are predictable, usually pharmacological reactions associated with calcipotriene and topical corticosteroids. The safety of MC2-01 cream is similar to the known safety properties of taclonex.

The active ingredient of the MC2-01 cream is calcipotriene/betamethasone dipropionate. The drug utilizes MC2 Therapeutics' PADTM technology to quickly absorb the cream formulation caspase/betamethasone dipropionate into the skin, providing a good moisturizing condition that allows patients to continue their activities in their daily lives.

MC2-01 in progress (from MC2 Therapeutics official website)

Taclonex is a topical suspension of calcipotriene/bepropionate (0.005%/0.064%) developed by LEO Pharma and approved by the FDA for scalp and body plaque in people aged 18 and over. Treatment of psoriasis or scalp plaque psoriasis in children aged 12-17 years.

Dr. Linda Stein Gold, a researcher in the Phase 3 trial, said: "The significant improvement in MC2-01 treatment success rate and patient-reported treatment convenience is particularly encouraging. Using MC2-01 PAD? formulations can improve patient satisfaction, And further positive impact on the actual treatment results. Therefore, PAD? technology is expected to redefine the treatment plan."

Jesper J. Lange, president of MC2 Therapeutics, also said: "I am very satisfied with these superiority data for the head-to-head study of MC2-01 cream and taclonex, which is widely considered to be a first-line topical treatment for psoriasis. Psoriasis is A lifelong disease that has a major impact on the quality of life of patients. MC2-01 cream is designed to provide patients with new treatment standards to help them manage their condition effectively and conveniently, minimizing interference with daily life and social interactions. These data confirm the great potential of PAD® technology as a broad platform for developing new topical drugs.” (Sina Pharmaceuticals Compilation/David)

Article Reference Source: MC2 Therapeutics A/S announces positive top-line results from Phase 3 clinical trial comparing MC2-01 Cream to Taclonex? in adults with psoriasis

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