Larimar Therapeutics Reports the Results for Nomlabofusp in P-II Trial for the Treatment of Friedreich’s Ataxia
Shots:
- The P-II clinical trial evaluated the safety & efficacy of Nomlabofusp (CTI-1601) vs PBO in patients with Friedreich’s Ataxia (FA). The study consists of two cohorts evaluating CTI-1601 in doses of 25mg (Cohort 1, n=13) & 50mg (Cohort 2, n=15) at day 14 (QD) or day 28 (QOD)
- The results depicted a median change in FXN levels in skin cells &buccal cells from baseline of (2.81 & 5.57 vs -0.53) & (0.56 & 0.72 vs -0.35) at day 14 & (2.28 & 3.14 vs -0.34) & (0.03 & 0.48 vs -0.52) at day 28
- CTI-1601, a recombinant fusion protein delivering human frataxin to the mitochondria, received the RPDD, FTD & ODD from the US FDA & the PRIME designation by the EMA whereas the company expects to receive US FDA’s approval by H2’25
Ref: Larimar Therapeutics | Image: Larimar Therapeutics
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Shivani was a content writer at PharmaShots. She has a keen interest in recent innovations in the life sciences industry. She was covering news related to Product approvals, clinical trial results, and updates. We can be contacted at connect@pharmashots.com.
