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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