Redwood Pharma AB: Redwood Pharma starts production of RP101 for clinical trials
Following successfully completed toxicology and safety studies, Redwood Pharma has now started production of the drug RP101 for use in the forthcoming Phase II clinical trial. This is another important milestone in the development of RP101, the first therapy for treatment of moderate to severe dry eye in postmenopausal women.
Production of material for the upcoming clinical trial has now begun. This is done after finishing work upscaling and GMP (Good Manufacturing Practices) adaptation of the manufacturing process, as well as the production and validation of the necessary test procedures and analyses. This work has proceeded as expected and with good results.
"We are pleased to be able to take the next step in preparing for our Phase II clinical trial. In collaboration with our manufacturing partner Carbogen Amcis SA in France, we are now proceeding with the production of RP101. The material will be used for the treatment of postmenopausal women with chronic dry eye disease. The trial will evaluate the safety and efficacy of patients treated over a three-month period. This milestone continues to increase the value of the company, "says CEO Martin Vidaeus.
RP101 is the company's main development program of a new treatment of chronic dry eye disease in postmenopausal women. The active substance is a molecule that has already shown safety and efficacy in two clinical phase II studies conducted in the United States. The active substance has now been formulated in IntelliGel® to control release, reduce the number of doses and increase comfort. Redwood Pharma will conduct a Phase II clinical trial of RP101 in Europe. Chronic dry eye disease represents a large market with high medical needs. The market is expected to grow to $2.7 billion in 2022. RP101 will be the first treatment to restore a biological mechanism to treat a patient group of women after menopause. As there are already data from both development and clinics, the project is estimated to be able to come to the market more quickly, as well as lower capital requirements and development risks than programs based on new chemical substances.