Female Hair Loss Product Gets FDA Approval for Investigation

The US Food and Drug Administration (FDA) has approved the Investigational New Drug (IND) application for research into a regenerative female hair product.

The Hair Stimulating Complex (HSC660), an injectable soluble formulation of naturally-secreted growth factors developed by Histogen, will begin its first company-sponsored clinical trial to test its efficacy in women who suffer from hair loss.

Histogen focuses on regenerative medicines that stimulate patients’ stem cells to regenerate tissues, and HSC660 is vying to be its lead US product in female diffuse hair loss. The formulation is manufactured from the purification of cell condition media to enrich for key growth factors, such as keratinocyte growth factor (KGF), vascular endothelial growth factor (VEGF), and follistatin. These factors have proven important in hair formation and in the stimulation of resting hair follicles, with follistatin most notably being linked to the proliferation of hair follicle stem cell.

Martin Latterich, PhD, Histogen vice president of technical operations, said the formulation is the first complex biologic consisting of naturally-secreted growth factors to be approved as an investigational treatment for alopecia — a condition which researchers believe has autoimmune machinations and a genetic history.

“After seeing promising results in early trials of our cell conditioned media, we are excited to launch our first company-sponsored clinical trial of HSC660 in women,” Latterich said in a statement.

The trials Latterich is referring to were pilot and phase 1/ 2 clinical studies of a predecessor to HSC660. The therapy was tested for efficacy in treating male pattern baldness outside the US, reporting statistically significant results and a strong safety profile.

Another more recent study — a 10-patient trial sponsored by a physician in the US — showed significant results for the therapy in both men and women. Women reported a 100% response rate in the study, and the therapy also showed efficacy difficult-to-treat populations such as men 40-plus years old with temporal recession hair loss.