Dermata Therapeutics Inc (NASDAQ:DRMA) has requested the FDA to waive the requirements to complete a 90-day dermal minipig study and a standard dermal pharmacokinetics study before the End of Phase 2 meeting for its DMT310 acne program.
- The Company said it has already planned and budgeted to conduct both studies. The requests come as DMT310 has been used in clinical trials by over 170 patients exhibiting an acceptable safety and tolerability profile.
- Further, the FDA approved the Company to use DMT310 in the Company’s ongoing 180-subject Phase 2 study for rosacea.
- If the FDA grants the waiver request, the Company expects a cost savings of approximately $600,000 in development costs.
- Related: Dermata Stock Jumps On Positive Psoriasis Candidate Data.
- Alternatively, the FDA may waive the requirement to complete the 90-day dermal minipig study before the Phase 3 acne program but still require it to be completed before a New Drug Application submission.
- The Company has also submitted a request to waive the requirement to conduct the standard dermal pharmacokinetic study, based on the human tolerability and safety profile of DMT310 observed to date.
- If the FDA grants both waiver requests, the Company plans to immediately request an End of Phase 2 meeting with the FDA and initiate the Phase 3 acne program in 2H of 2022.
- Suppose the FDA grants the waiver request only for the standard dermal pharmacokinetic study or denies both waiver requests, the Company will start its Phase 3 program in 2023.
- Price Action: DRMA shares are trading 18.9% lower at $1.80 during the premarket session on the last check Monday.
