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SCM Life Science, Announces Interim Results of Phase 1/2 Clinical Atopy…. 68% of patients observed ‘significant symptom improvement’.
News
2022-01-28

SCM Life Science (SCM Life Science, KOSDAQ 298060, CEO Lee Byung-gun), a company specializing in cell therapy, On the 16th, the company announced the interim results of phase 1/2 clinical trials for atopic dermatitis of its pipeline "SCM-AGH" through an online channel.

 

According to the announcement, a significant improvement in atopic symptoms was observed in 13 of the 19 atopic patients who received SCM-AGH.

 

In a phase 1 clinical trial, Scm Life Science administered SCM-AGH three times every two weeks to 20 patients with moderate to severe atopic dermatitis and checked the patient's condition through visiting treatment for 12 weeks. Of these, 19 patients completed administration.

 

Twelve weeks after the first administration, 13 out of 19 patients reported an improvement in the EASI (Eczema Area and Severity Index), which evaluates the severity of atopic dermatitis, by more than 50%. Furthermore, among the patients whose EASI score improved by more than 50% at the 12th week visit, the efficacy of SCM-AGH was maintained in all (9 patients) who completed the additional treatment by 24 weeks.

 

SCM-AGH also produced remarkable interim results with regard to drug safety and side effects.

None of the registered patients had adverse reactions related to the drug.

 

Based on the results of phase 1 clinical trials, Scm Life Science is planning to launch phase 2 clinical trials of SCM-AGH around January 2021. Furthermore, in accordance with the License Out contract signed in 2019, phase 3 clinical trials will be conducted in Handok, which has domestic copyright.

 

In particular, the clinical trial evaluated by the dose setting test showed similar effects to high capacity at low doses. The company said it intends to provide treatment opportunities for more atopic dermatitis patients by reducing production costs and treatment costs in terms of commercialization by proving its effectiveness with low doses from phase 2 clinical trials.

 

Atopic dermatitis is a chronic inflammatory skin disease that causes itching and dry skin. More than 1 million people in Korea and 130 million people around the world suffer from the disease. Due to the widespread outbreak of the disease around the world, the size of the related market reaches about 8.5 trillion won, increasing rapidly every year.

 

SCM-AGH has many advantages over existing treatments in terms of convenience and cost. Dupigent (sanopy), which is currently the most widely used, should be administered every two weeks to relieve symptoms of atopic dermatitis. Due to the frequency of administration, the cost that the patient has to pay about 40 million won per year.

 

On the other hand, SCM-AGH is expected to reduce the effort of patients to go to the hospital and reduce the cost burden as the drug remains effective for more than 6 months after administration.

 

An official from SCM Life Science said, "Based on the clinical results of SCM-AGH, we plan to discuss technology transfer with global companies at the JPMorgan Healthcare Conference in January next year."

 

The "JPMorgan Healthcare Conference" is the world's largest pharmaceutical bio event, attended by public, private companies, and investors to discuss technology transfer and partnering with academic events. The JPMorgan Healthcare Conference, which marks its 39th anniversary next year, will be held online from the 11th to the 14th of next month in the aftermath of COVID-19.

 

Meanwhile, CEO Lee Byung-gun shared the progress of the pipeline under development by SCM Life Science in addition to SCM-AGH and announced his vision for future businesses.

 

Currently, SCM Life Science is conducting phase 2 clinical trials for GHVD treatments and phase 2a clinical trials for acute pancreatitis treatments in Korea. It is also taking phase 2b clinical trials for metastatic kidney cancer in the United States and 1/2 clinical trials for acute lymphocytic leukemia in Italy.

 

Furthermore, the treatment of ARDS will be approved for phase 2a clinical trials in the first quarter of 2021 after completing the application for approval of clinical trial plans in Korea, and spinal encephalopathy will also be submitted for IND.