The FDA provided encouraging input on Kuria Therapeutics’ development plan for KTX-1161 for corneal endothelial dysfunction during a pre-Investigational New Drug (IND) interaction, according to the pharmaceutical company, which is working on innovative ophthalmic and dermal treatments.
A topical ophthalmic solution version of SCO-116, a brand-new Nrf2 activator being created under a licence from Scohia Pharma, is called KTX-1161. Kuria is developing KTX-1161 to treat patients with disorders of the corneal endothelium, particularly individuals with Fuchs’ endothelial corneal dystrophy and those having cataract surgery.
The pre-IND consultation’s goals were to get FDA approval for Kuria’s nonclinical IND-enabling plans and to get advice on how to structure the phase 2 clinical programme for KTX-1161. FDA provided detailed instructions on the remaining nonclinical KTX-1161 investigations, including the decision to waive a number of studies due to the drug’s predicted minimal systemic exposure. The FDA collaborated with other parties on the design of the anticipated clinical trials as well as the intended outcomes for upcoming registrational studies.
Dr. Keith Ward, president and CEO of Kuria, said, “We are thrilled by the favourable, constructive, and practical feedback provided by the FDA during this pre-IND discussion. “According to FDA advice, we can implement a shortened nonclinical approach for KTX-1161 and go straight to phase 2 clinical development after the IND has been approved. Importantly, we appreciate FDA for providing direction for the design of upcoming phase 3 initiatives in addition to our phase 2 programme. We anticipate continuing our collaboration with FDA on our upcoming development programme.
An important unmet medical need is corneal endothelial dysfunction, which can result from a wide range of injuries and illnesses and eventually lead to blindness, corneal edoema, and loss of vision. Patients with disorders of the corneal endothelium cannot currently be treated with any drugs that have been licenced, leaving corneal transplantation as their sole curative option. Many pieces of evidence point to Nrf2 activation’s significance in enhancing corneal endothelium function, and KTX-1161 may be useful for a number of related disorders that pose a threat to eyesight. A US-based pharmaceutical business called Kuria Therapeutics, Inc. is focused on creating cutting-edge treatments for skin and eye diseases.
