Benzinga | Nov 2, 2020 08:08AM EST

PolarityTE Announces Successful Completion Of Initial Pre-IND Interaction With FDA For SkinTE; Co. Plans To Submit An IND Submission For One Or More Indications In Second Half Of 2021

PolarityTE Plans to Submit an Investigational New Drug (IND) Submission for One or More Indications in the Second Half of 2021

SALT LAKE CITY--(BUSINESS WIRE)-- PolarityTE, Inc. (NASDAQ:PTE) announced that it recently received written responses from FDA following a Type B Pre-IND meeting request that the Company submitted in August 2020 regarding an indication for SkinTE to treat diabetic foot ulcers (DFUs). FDA's responses included, among other things, feedback and recommendations on SkinTE manufacturing, preclinical studies, clinical data submitted in the Company's briefing package, and additional clinical studies to support our IND submission. The Company expects to discuss additional indications in pressure injuries and traumatic wounds with FDA in the coming months. Based on the FDA input gathered in these interactions, the Company plans to prepare and submit an IND to enable clinical studies for one or more indications in the second half of 2021.

The Company believes that the guidance and recommendations received from FDA provide a well-defined regulatory pathway, and plans to proceed with IND-enabling activities over the coming months. In addition, the Company is developing a strategy to pursue multiple indications based on its continuing dialog with the FDA regarding the DFU indication, and additional planned meetings regarding other indications.

The Company previously announced that it will report earnings for calendar third quarter 2020 on November 9, 2020, and plans to provide additional detail and discuss the FDA's feedback during the earnings call on November 9, 2020 at 8:00 a.m. Eastern Time. A webcast of the conference call can be accessed by using the link below.

Earnings Call Webcast -- CLICK HERE

Richard Hague, President and Chief Operating Officer, commented: "We are pleased to have received helpful feedback from FDA regarding SkinTE for treatment of DFUs, and we believe that FDA's responses generally track established guidance for sponsors of biologics. We plan to continue our dialog with FDA over the coming months as we work to finalize our development plan for DFUs and other indications such as trauma and pressure wounds."