MSI-78 Magainin Pharmaceuticals

Area of Science:

• Pharmacology
• Dermatology
• Infectious Diseases

Background:

• Magainin is developing MSI-78, a 22-amino acid peptide derived from frog skin compounds, as a topical anti-infective agent.
• MSI-78 exhibits broad-spectrum activity against Gram-positive bacteria, Gram-negative bacteria, anaerobic bacteria, and Candida albicans.

Purpose of the Study:

• To evaluate the efficacy and safety of MSI-78 for the treatment of infections in diabetic foot ulcers.
• To compare MSI-78 with orally-administered ofloxacin in a pivotal Phase III trial.

Main Methods:

• A pivotal Phase III trial involving 584 patients with diabetic foot ulcers was conducted.
• Statistical equivalence was assessed between MSI-78 and ofloxacin based on clinical response at day 10 and day 28, and follow-up.
• A second Phase III trial confirmed these findings, with additional data on organism eradication and wound healing presented.

Main Results:

• MSI-78 demonstrated statistical equivalence to ofloxacin in treating diabetic foot ulcer infections.
• Both treatments were comparable in terms of organism eradication and wound healing rates.
• MSI-78 showed a favorable side-effect profile, with less insomnia compared to ofloxacin.

Conclusions:

• MSI-78 is a promising topical anti-infective agent for diabetic foot ulcers, with efficacy comparable to oral ofloxacin.
• Further research is warranted to explore MSI-78's wound-healing capabilities in various types of wounds.
• MSI-78 has potential for treating other infections, including those associated with surgical wounds, decubitus ulcers, and burns.