New Topical Agent for Alopecia to Enter Phase 2 Trials

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Pelage Pharmaceuticals today announced it has secured financing to begin phase 2 trials of PP405, its novel topical agent for androgenetic alopecia and other forms of hair loss.

PP405 is a non-invasive, topical small molecule designed to inhibit the mitochondrial pyruvate carrier (MPC) to reactivate dormant hair follicle stem cells and restart hair growth, according to the company.

"We are pleased to announce that we have completed a first-in-human phase 1 clinical trial that demonstrated 7 days of topical dosing with PP405 was safe and well-tolerated, and showed statistically significant activation of hair follicle stem cells,” said Daniel Gil, PhD, Pelage Pharmaceuticals’ chief executive officer, in a news release.¹

Translational data from the phase 1 trial will be presented in the late breaking abstract sessions of the 2024 AAD Annual Meeting on Saturday, March 9, at 11:40 am PT.

Qing Yu Christina Weng, MD, the company's chief medical officer, told Dermatology Times, “the phase 1 trial was a randomized control study with topical dosing of either PP405, our small molecule treatment, or placebo for 7 days, focusing on safety and pharmacokinetics. The cohort included 20 male subjects with androgenetic alopecia, and we look forward to enrolling both women and men in our phase 2a trial.

“The phase 1 study was also designed to determine a dosing regimen for PP405. We compared 1x/day topical dosing with 2x/day topical dosing and discovered the same biological and safety response to both. Moving forward into phase 2a, we will proceed with 1x/day dosing.

“Our phase 1 study shows no detectable levels of drug in the blood, while simultaneously achieving the levels of PP405 in the scalp skin associated with hair growth from translational studies.”

With $16.75 million in Series A financing, the company expects to advance PP405 to phase 2a in the second half of this year.

"What we've observed is that in people who experience hair loss, the actual hair follicle stem cells are still present but have reverted to a dormant state. We have uncovered a small molecule able to stimulate cellular metabolism to re-awaken hair follicle stem cells and spur new hair growth," said William Lowry, PhD, Pelage’s scientific co-founder, in the news release.

“By targeting the intrinsic metabolic properties of hair follicle stem cells, Pelage's treatment has potential to induce robust hair growth for all genders, skin types, and hair types,” the company states on its website.²

The company also claims that PP405 may also have applications for other types of hair loss, such as telogen effluvium and chemotherapy-induced hair loss.

References

1. Pelage Pharmaceuticals announces $16.75M series A financing led by GV to revolutionize regenerative medicine for hair loss. News release. February 27, 2024. Accessed February 27, 2024. https://www.prnewswire.com/news-releases/pelage-pharmaceuticals-announces-16-75m-series-a-financing-led-by-gv-to-revolutionize-regenerative-medicine-for-hair-loss-302071733.html
2. A new approach to hair loss grounded in stem cell biology. Pelage Pharmaceuticals. Accessed February 27, 2024. https://pelagepharma.com/