Idera Pharmaceuticals Inc (NASDAQ:IDRA) reported that the U.S. FDA has granted Fast Track status for the firm’s key development candidate IMO-2125 in together with Ipilimumab for the cure of “anti-PD-1” refractory metastatic melanoma in together with ipilimumab treatment. FDA’s Fast Track plan is intended to expedite the review and development of biologics and drugs to cure grave or life-threatening ailments with clinical or non-clinical data showcasing the potential to resolve unmet medical needs. Such medicines may be eligible for Fast Track designation.
Joanna Horobin, M.B., Ch.B., the Chief Medical Officer of Idera, reported that this fast track status exhibits another promising step for the advancement of IMO-2125 and is a direct recognition of the grave unmet need that prevails for people who do not gain from anti-PD-1 treatment. They are excited with the remarkable response pace that has been noted to date so far with “IMO-2125” together with ipilimumab and are keen to continue registering more subjects through both the Phase II expansion of their current study and commencing the Phase 3 study early next year.
Fast Track designation is planned to facilitate advancement and expedite review of medicines to treat life-threatening or serious conditions. A drug that is planned to cure a life-threatening or serious condition with clinical or nonclinical data that showcase the prospect to address an unmet medical requirement may succeed for Fast Track designation. When Fast Track status is requested later in advancement, available clinical report should showcase the potential to resolve an unmet medical requirement.
There are prospects for frequent interactions with the assessment team for a fast track offering. Besides, such an offering could be eligible for priority assessment if supported by clinical report at the time of NDA, BLA or efficacy supplement submission.
In the last trading session, the stock price of Idera gained more than 2% to close the day at $1.92.