Kala Pharmaceuticals receives FDA Fast Track Designation for human MSC-S therapy
pharmafile | April 13, 2023 | News story | Medical Communications |
Clinical-stage biopharmaceutical company Kala Pharmaceuticals has announced that the FDA has granted it Fast Track Designation for its human mesenchymal stem cell secretome (MSC-S) therapy, KPI-012.
KPI-012 is used for the treatment of persistent corneal epithelial defect (PCED), a rare disease which is defined as a persistent, non-healing corneal defect or wound which is refractory to conventional treatments. If left untreated, PCED can lead to infection, corneal ulceration or perforation scarring, opacification and significant vision loss.
In February 2023, Kala began the CHASE phase 2b trial, where two patients with PCED were treated with a high dose of KPI-012 (3 u/ml) four times a day. In March 2023, it was reported that both patients successfully completed at least one week of dosing with no safety concerns. The trial has now advanced to a second cohort of around 90 patients, which will evaluate the safety and tolerability of two doses of KPI-012 in ophthalmic solution (3 u/ml and 1 u/ml) against vehicle dosed topically four times a day for 56 days.
Kim Brazzell, PhD, head of R&D and chief medical officer at Kala Pharmaceuticals, stated: “There is a significant unmet need for patients suffering from PCED, which can lead to many complications and sequelae, including vision impairment, infection, corneal perforation and significant pain and discomfort. There are currently no approved pharmaceutical treatments for the majority of PCED patients, and KPI-012’s multifactorial mechanism of action is a potential solution to address all underlying etiologies of PCED. We look forward to working with the Agency [FDA] to efficiently advance KPI-012 through the development and review process to fulfil our greater mission of delivering a treatment to the roughly 100,000 patients in the US, and thousands more globally, suffering from PCED.”
James Spargo
