In premarket trading on Tuesday, MediWound Ltd. (MDWD) shares gained 16.04% to $5.21. MediWound stock decreased -3.02% to close at $4.49 last trading session. MDWD stock traded 0.14 million shares, which is less than the average daily volume of 0.4 million shares for the last 50 days. Following news of positive overall results from a phase 3 pediatric study, MDWD stock is surging in pre-hour trades.
What was the purpose of that MDWD study?
In addition to developing, manufacturing, and distributing biopharmaceutical products for tissue repair and regeneration, MediWound manufactures novel, cost-effective, biotechnological products. MDWD develops bioactive therapies focused on next-generation wound care, burn treatment, and tissue repair using its enzymatic technology platform.
Medical Devices and Diagnostics Division of MDWD has developed NexoBrid, a commercial orphan biological product designed to treat thermal burns without the need for surgery or anesthesia. NexoBrid by MDWD is a bromelain-based biological product that is sterile, nontoxic, and induces the removal of burn eschar in four hours without affecting surrounding healthy tissue.
Positive topline results were announced today by MediWound for its pivotal phase 3 pediatric clinical studies (CIDS – Children Innovation Debridement Study).
- Compared with a standard of care (SOC), MDWD evaluated the effectiveness and safety of NexoBrid in treating children suffering severe thermal burns.
- In the MDWD study, the three primary endpoints were statistically significant.
- With NexoBrid, the time required for the complete removal of eschar as well as the required amount of surgical excision (surgical need) was significantly shortened, while the scar quality was comparable to SOC.
- A secondary endpoint of the MDWD study showed a reduction in surgical excision and reduction in the need for autograft in deep partial burns alongside the primary endpoint.
- In the MDWD study, a favorable trend in eschar removal process blood loss was seen.
- NexoBrid was also found to be safe and well-tolerated in the MDWD study.
- In MDWD, mo detriment to wound healing has been observed.
- The time it took for patients treated with NexoBrid to complete wound closure was comparable to that of patients treated with SOC.
- With NexoBrid, the estimated median time for wound closure was 32 days, while with SOC, it was 34 days.
- NexoBrid was found in all subjects to be safe and well tolerated by the study DSMB (Data Safety Monitoring Board).
- There were no safety concerns identified in the study population.
A brief analysis of the MDWD study:
The results of the study, that were robust across all primary endpoints, corroborated MDWD’s pivotal phase 3 clinical studies in adult patients, and strongly demonstrated NexoBrid’s positive effects on pediatric burn patients. It is encouraging for MediWound (MDWD) to see that its NexoBrid could be a treatment option for pediatric burn patients with high-level results.