Processa Pharma's Investigational Candidate Improves Gastroparesis-Associated Clinical Symptoms

  • Processa Pharmaceuticals Inc PCSA announced topline results on the clinical symptoms associated with gastroparesis (partial paralysis of the stomach) from the Phase 2A study of PCS12852. 
  • The trial was designed to evaluate two dosage regimens of PCS12852 vs. placebo. 
  • 100% of the patients receiving the 0.5 mg daily dose of PCS12852 and no rescue medication from Day 22-28 had a clinically meaningful reduction in the total ANMS GCSI-DD score (i.e., a reduction of greater than 0.5 from baseline), while only 57% of the placebo group had a clinically meaningful reduction. 
  • In addition, the magnitude of the improvement for the total ANNMS GCSI-DD score and the subscores was greater for the 0.5 mg PCS12852 group than the placebo group. 
  • The 0.1 mg PCS12852 daily dose group showed little to no improvement in gastroparesis symptoms.
  • PCS12852 was shown to be generally well-tolerated, with most AEs occurring in the 0.5 mg dose group and consisting of either a mild or moderate grade. 
  • The results, in addition to the previously announced improvements in gastric emptying in patients that received the daily dose of 0.5 mg of PCS12852, further support initiating a PCS12852 Phase 2B trial in 2023 for gastroparesis.
  • Price Action: PCSA shares are up 9.47% at $2.08 on the last check Wednesday.
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