Dermata announces receipt of Type C meeting response from the FDA and plans to initiate a phase III program for acne for DMT 310.
Dermata Therapeutics, Inc. announced that it has received a response from the FDA to the Company's Type C Chemistry, Manufacturing, and Controls ("CMC") meeting request
The FDA's response stated that the Company has provided documentation of its CMC procedures and controls sufficient to support the initiation of Phase III studies. The Company has also submitted an end of phase II meeting package to the FDA to discuss clinical requirements to advance DMT 310 into Phase III development as a treatment for moderate-to-severe acne.
The Company expects to receive written feedback on the end of phase II meeting package from the FDA by the end of June 2023. Upon agreement with the FDA, the Company plans to initiate the Phase III program for acne in the second half of 2023. If the Company is able to successfully complete the Phase III program, it believes the results could support submission of a new drug application for DMT 310 for the treatment of moderate-to-severe acne.
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