HEALIOS K.K., an associate of Athersys Inc (NASDAQ:ATHX), completed the enrollment patients in the ONE-BRIDGE trial.
In this clinical trial, the company will evaluate the effectiveness of Invimestrocel to treat patients suffering from pneumonia-induced ARDS (acute respiratory distress syndrome). The trial has two cohorts of patients.
Cohort 1, which involved 30 patients, is designed as an open-label, randomized trial. Its main aim is to treat the patients with Invimestrocel without applying oxygen for 28 days after allocating treatment.
Cohort 2, which involves five patients, is designed to treat patients suffering from ARDS induced by a coronavirus and measure its safety.
Athersys conducts its trial using Invimestrocel in the US
Apart from the above, Athersys will conduct its trial in the US using Invimestrocel to evaluate the efficacy in patients with ARDS caused by coronavirus or other pathogens. The US FDA granted Fast Track and RMAT (Regenerative Medicine Advanced Therapy) for the ARDS program.
Posts an impressive growth of 333%
Athersys reported a robust growth of 333% YoY to $1.3 million in Q4 2020. The company generated collaboration revenues from an agreement with Healios. However, its full-year revenues declined by $4.2 million to $1.4 million in 2020.
Its R&D spending rose to $18.7 million (up 146% YoY) in Q4 2020. The increase is mainly due to expenses associated with clinical study and development costs related to the manufacturing process besides stock compensation expense. Athersys loss is widened to $22.2 million (up 124% YoY) in Q4 2020.
Signs a collaborative deal with HEALIOS K.K
Athersys entered a collaboration deal with HEALIOS K.K. Under this agreement, both firms will continue their mutual commitment to developing Invimestrocel in Japan.
Hardy TS Kagimoto, CEO and Chairman of Healios, will withdraw section 220 demand and dismiss litigation filed under section 220 in the Delaware Court of Chancery. Following the agreement, Athersys will appoint Kenneth H. Traub as a director in the company.
Chairman of the board of Athersys, Ismail Kola, said the collaboration accord signifies a positive development for the company. He said the company will continue collaboration with Healios.
Kola said the collaboration accord allows both the companies to concentrate on advancing the late-stage programs for Invimestrocel.