- Larimar Therapeutics Inc LRMR received meeting minutes from the FDA following a recent Type C Meeting.
- The company plans to submit a complete response to the CTI-1601 clinical hold in Q3.
- In conjunction with the complete response, Larimar is proposing as CTI-1601's next trial a Phase 2, four-week dose exploration study in Friedreich's Ataxia starting at the lower dose levels tested in the company's Phase 1 multiple-ascending dose trial.
- This study will provide additional data on safety & tolerability and whether lower doses for longer periods can increase frataxin levels while maintaining acceptable exposures.
- Related: FDA Asks For Additional Data To Resolve Clinical Hold On Larimar's Friedreich's Ataxia Program.
- Data from Phase 1 trials showed that 50 or 100 mg of CTI-1601, administered daily for at least seven days, resulted in frataxin levels in peripheral tissues (buccal cells).
- Cohort 1 of the MAD trial evaluated a 25 mg dose and explored a daily dosing regimen for only four days.
- Larimar ended the June quarter with a cash balance of $54.9 million, which provides a projected cash runway through Q3 of 2023.
- Price Action: LRMR shares are up 14.64% at $2.27 during the premarket session on the last check Friday.
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