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Dive into the Biopharma Space

Stay up-to-date on major biopharma news, deeper dives into specific companies and biopharma themes, and how it all relates to biopharma partners.

Upcoming Phase 3 Trial Initiations To Watch For

Here's some upcoming phase 3 clinical trials! *not on clintrials gov* 😉

89bio plans to initiate a phase 3 for Pegozafermin to treat NASH. Company noted that phase 2b ENLIVEN data supports the advancement to phase 3. Company working with FDA on phase 3 trial guidance.

Harmony Biosciences plans to initiate a phase 3 study of WAKIX (pitolisant) to treat Prader-Willi Syndrome (PWS). Positive topline results from phase 2 trial reported on 11/1/22. End-of-Phase 2 meeting with FDA scheduled for Q2 2023 to discuss phase 2 study results and to propose Phase 3 trial.

PDS Biotechnology plans to initiate a phase 3 study for PDS0101 + Keytruda to treat head and neck cancer. They presented at ASCO 2023 highlighting data generated from VERSATILE-002 Phase 2 study. Plans to initiate Phase 3 VERSATILE-003 study in the fourth quarter of 2023.

Incyte plan to initiate a phase 3 study of Povorcitinib to treat Vitiligo. They presented phase 2b data at the AAD meeting. Incyte plans to move into phase 3 study, pending FDA discussions.

Deciphera Pharmaceuticals plans to initiate a phase 3 study for Qinlock (Ripretinib) to treat GIST 2nd line (Gastrointestinal stromal tumors). Based on the results of the ctDNA analysis and discussions with the FDA, the Company plans to initiate the INSIGHT pivotal phase 3 study of QINLOCK versus sunitinib in second-line GIST patients with mutations in KIT exon 11 and 17/18 in the second half of 2023.

*ok this ones on clintrials (but we had it first 😅)

Evelo Biosciences plans to initiate a phase 3 study for EDP1815 to treat Psoriasis. They received feedback from the FDA, EMA, and MHRA regarding the proposed registrational trial design of EDP1815 in psoriasis, including the primary and secondary endpoints. Evelo is incorporating the comments received into its Phase 3 study designs.


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