4D pharma plc (NASDAQ:LBPS) has announced additional clinical data from Part A of its Phase 1/2 trial of MRx-4DP0004, an orally-delivered single strain Live Biotherapeutic for asthma.
- As previously announced, Part A met the primary endpoint, and the safety profile of MRx-4DP0004 was comparable to placebo.
- In addition, MRx-4DP0004 showed activity across multiple secondary endpoints compared to placebo.
- Part B of the trial is expected to enroll up to 90 patients and will assess clinical efficacy in addition to exploratory immune and microbiome biomarkers.
- Related: 4D pharma To Stop Testing Asthma Med in COVID-19 Patients.
- 61.1% of patients receiving MRx-4DP0004 experienced any adverse event (AE) compared to 75.0% of patients receiving placebo, of which only two were possibly related to MRx-4DP0004.
- All AEs were mild or moderate in severity. No serious adverse events (SAEs) related to treatment were reported.
- At the end of treatment, 83.3% of patients receiving MRx-4DP0004 experienced reductions in asthma control score, compared to 56.3% in the placebo arm.
- 50% of patients receiving MRx-4DP0004 reduced their use of SABA, compared to 18.8% of patients receiving placebo.
- 50.0% of patients receiving MRx-4DP0004 experienced a clinically meaningful increase in quality of life, compared to 31.3% receiving placebo.
- Price Action: LBPS shares are down 6.04% at $4.03 during the market session on the last check Thursday.
