Successful Phase 2b Clinical Trial Results
The Phase 2b clinical trial for Inovasarm showed a 42% greater relative loss of fat mass compared to the placebo group, with a statistically significant preservation of total lean mass. The trial demonstrated a reduction in the proportion of patients experiencing a decline in physical function.
Positive Safety Profile
Inovasarm displayed a positive safety profile in the Phase 2b trial, with no significant adverse events such as gastrointestinal side effects or liver injury. The safety profile was maintained even after discontinuation of semaglutide.
Novel Modified Release Formulation
A new modified release oral formulation of Inovasarm was developed, demonstrating a distinct target product release profile and extended patent protection through 2037.
Optimistic Regulatory Pathway
Veru has scheduled a meeting with the FDA for regulatory clarity on the Phase 3 program, with previous FDA feedback supporting the clinical path forward.
Reduction in Operating Expenses
Research and development costs decreased from $4.8 million to $3 million, and selling, general, and administrative expenses decreased from $5.8 million to $5 million.