Krystal Biotech to initiate manufacturing of Phase 3 clinical material in Nov.
The company said, "CMC alignment with the U.S. Food and Drug Administration includes a) support for the proposed commercial manufacturing process, b) the proposed analytical methods and corresponding qualification and validation plans - inclusive of key release assays such as potency, purity and identity and c) the comparability protocol, which helps assess how similar the product derived from our GMP process runs in our Ancoris facility is to the original product used in the Phase 1/2 trial of KB103. Analytical methods are used to assess how reliably and consistently the key product characteristics can be determined in order to ensure patients receive safe and effective product.Following alignment with the FDA on our commercial process and engineering run, we plan to initiate manufacturing of our Phase 3 clinical material at Krystal's Ancoris GMP facility in early November. We anticipate releasing this Phase 3 clinical material in 1Q 2020 and will initiate the B-VEC Phase 3 pivotal trial following release of Phase 3 material. We expect to meet with the FDA before the end of 2019 to finalize trial design and endpoints for the upcoming pivotal trial of B-VEC. Earlier this year B-VEC received RMAT designation from the FDA and PRIME eligibility from the EMA."