Hair removal is not an underserved market, but it is also not an underserved market. According to Christina Wen, a practicing dermatologist and chief medical officer of Pelage Pharmaceuticals, the available drugs are older products originally developed for other indications and do not address the underlying cause of hair loss. It is said that it has not been addressed.
Based in Los Angeles, Pelage uses a regenerative medicine approach to address hair pathways that are blocked for a variety of reasons and restore hair growth. In its first human trials, the startup found results showing that hair follicle stem cells were activated after seven days of topical application of the experimental drug.
Data from the phase 1 trial has been accepted for presentation at the American Academy of Dermatology meeting in March in San Diego. The company will also begin preparations for a larger Phase 2 clinical trial later this year to evaluate treatments for other types of hair loss, including androgenetic alopecia (pattern baldness) and chemotherapy-induced hair loss. It is planned.
“What we can do is directly approach the stem cells that are the cause (of hair loss),” Wen said. “This is a very clear pathway and is well understood from years of research in the lab.”
Pelage’s technology is based on stem cell research at UCLA. The startup’s scientific co-founders were researching signal transduction that could activate stem cells. That research began to focus on dormant hair follicles. Follicles can become dormant due to age, environment, hormonal changes, stress, medication, and other factors. In these cases, the hair follicles are still present, Wen said, but they just aren’t circulating as well as they used to.
Hair growth occurs in a continuous natural cycle. In addition to the growth phase, there are catagen, resting, and molting phases. Signals from stem cells allow follicles to move from one stage to the next, Wen said. At the end of the resting phase, called the telogen phase, the hair falls out. Professor Wen said hair loss occurs when hair follicles become stuck in the telogen phase and are unable to progress to the anagen phase. Pelage’s drug candidate, codenamed PP405, is a small molecule designed to inhibit the mitochondrial pyruvate carrier (MPC), a protein that plays a role in a variety of physiological processes.
Pelage CEO Daniel Gil said that for hair, blocking MPC is like turning on the metabolism, which has the effect of turning the growth cycle back on. A mouse study conducted by UCLA found that inhibiting MPC accelerates the hair cycle, resulting in normal hair follicle formation within 30 to 40 days after treatment. The results were published in Nature Cell Biology in 2017.
The Phase 1 trial, conducted last fall, enrolled 20 participants, all of whom were men. The primary objective was to evaluate the safety of PP405. Both once and twice daily applications were tested. Minoxidil, a vasodilator that won additional approval for androgenetic alopecia in 1988 and was introduced to the market as “Rogaine,” is applied twice daily.
Pelage’s drug was well tolerated, with no side effects reported in the Phase 1 trial. Gill said Michael Jung, a professor of chemistry and biochemistry at UCLA and one of Pelage’s scientific co-founders, designed PP405 to have the property of keeping the molecule in the scalp and not entering the bloodstream. It is said that he did. Trial results showed that the drug was successful on both counts. The results also show that the molecule engaged the target and provide mechanistic evidence, Wen said.
The Phase 2 clinical trial is expected to enroll approximately 60 participants, both male and female. Wen said it is important to develop drugs that work for all skin types, hair types and genders. Finasteride, first approved in 1992 to treat symptoms of enlarged prostates and later approved for alopecia (sold under names such as Propecia, among others), is known for its ability to increase testosterone levels. Yes, Wen said, but it cannot be used by women. Phase 1 trials showed that once-daily use of PP405 was as effective as twice-daily application, Gill said. Gill also previously oversaw research and early clinical development at beauty giant Allergan. Phase 2 trials will evaluate once-daily dosing of the drug.
In addition to older treatments like minoxidil and finasteride that have received additional approval for hair loss, other treatments are entering the hair loss market, including some that have not been reviewed by the FDA. I am. Injection of stem cells into the scalp is one such unapproved treatment. Gill said the great thing about PP405 is that it works on a patient’s own stem cells.
“You don’t need to inject stem cells into the hair follicle; the stem cells are there,” he says. “This is a great regenerative medicine story.”
Besides Jung, Pelage’s other scientific co-founders are UCLA professors William Rowley and Heather Kristofuk. Pelage was spun out from the university in 2018. The following year, an agreement was reached that gave Allergan an option to acquire the startup. Gill said the deal provided Perage with non-dilutive financial support. Allergan itself was acquired by AbbVie in 2020. After that deal closed, Perage and AbbVie agreed to terminate the option.
Perage plans to use the remainder of its $16.75 million Series A funding, which closed in mid-2023 but was not announced until this week, to fund the Phase 2 trial. Unlike cancer and gene therapy clinical trials, which are expensive and lengthy, hair loss clinical trials are much cheaper because they are quick to enroll and run. Gill said the funding is sufficient to cover both Phase 1 and Phase 2 testing. GV led the Series A round, which included participation from Main Street Advisors, Visionary Ventures, and YK BioVentures.
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