Hair Loss Cure 2020 | Hair loss blog with the latest news updates.

Update: July 20, 2024

We now have more details on the Phase 2 trials for PP405. Including a short survey to determine eligibility. All 6 US states that I mentioned in the last update are now recruiting volunteers (with Texas having two locations). You have to be between the ages of 18-55, and once-a-week visits will be required for 16 weeks. The product comes in the form of a topical gel. Pelage Pharmaceuticals also has an update with the above link on its home page.

Update: June 12, 2024

Pelage Pharmaceuticals’ Phase 2 clinical trials of PP405 officially started on June 5, 2024. They are currently recruiting volunteers in Indiana, Minnesota, Texas and Utah. Still to come are California and Virginia. The primary completion date is December 2024, and the study completion date is February 2025. PP405 is an inhibitor of mitochondrial pyruvate carrier (MPC).

Pelage Pharmaceuticals Logo.

Pelage Pharmaceuticals

I previously wrote about Pelage Pharmaceuticals in my 2019 post related to the research of its President and co-founder Dr. William Lowry. The other co-founders are Dr. Heather Christofk and Michael Jung. I also covered the findings of Dr. Lowry and Dr. Christofk’s UCLA team in a 2017 post.

These UCLA researchers discovered two topical compounds (RCGD423) and (UK5099) that regrew hair in mice via different mechanisms. Both drugs involve an increase in lactate production. This in turn activates hair follicle stem cells and leads to increased and quicker hair growth.

Dr. Lowry’s patent can be found here. Patent and technology rights to both topical drugs have been exclusively licensed to Pelage Pharmaceuticals by UCLA.

RCGD423

RCGD423 activates the JAK-STAT signaling pathway, which in turn leads to an increase in lactate production. This extra lactate activates hair follicle stem cells and results in quicker hair growth. The main 2017 study on RCGD423, lactate dehydrogenase activity and hair follicle stem cell activation can be read here. I also covered it in my earlier linked posts related to the work of Pelage co-founders Dr. William Lowry and Dr. Heather Christofk.

UK5099

UK5099, blocks pyruvate (a glucose metabolite) from entering cell mitochondria. This also results in an increase in lactate production in the hair follicle stem cells, and therefore accelerates hair growth. There is a 2015 study from China related to the application of mitochondrial pyruvate carrier blocker UK5099 and its effects on prostate cancer cells.

Update: May 6, 2024

Pelage Pharmaceuticals Phase 2 Clinical Trials Start in June 2024

Yesterday, a reader e-mailed a new link on Pelage Pharmaceuticals’ Phase 2 clinical trials for its PP405 inhibitor of mitochondrial pyruvate carrier (MPC). The Phase 2 trials are set to begin in June 2024 and will involve 60 participants. Half of these will take a PP405 0.05% topical gel once per day, and the other half will get a placebo vehicle daily gel. The study primary completion date is December 2024, and actual completion date is February 2025.

Recruitment will likely start soon, and I assume it will be in the US based on the listed contact person and phone number. The contact e-mail is listed as clinicaltrials@pelagepharma.com. Please DO NOT call them now as the recruitment has not yet commenced and they might get annoyed.

If you are between the ages of 18-55 and have androgenetic alopecia, you can participate. However, the inclusion criteria for men and women is specific:

Males must have an AGA modified Norwood-Hamilton Classification score of Type III vertex, Type IV or Type V.
Females must have a Savin classification score of I-2, I-3 or I-4.

Update: March 9, 2024

Positive Phase 1 Clinical Trial Results

Earlier today, Pelage Pharmaceuticals gave a positive update on its novel small molecule PP405. Full summary can be read here. In Phase 1 clinical trials, PP405 reactivated dormant hair follicle stem cells and triggered hair growth. The company’s presentation was made by Dr. Christina Weng and titled: “Inhibition of pyruvate oxidation activates human hair follicle stem cells ex vivo”. Pelage will begin its multi-center Phase 2a trial of PP405 in mid-2024. It will recruit both men and women with androgenetic alopecia.

Their description of this unique hair growth molecule is as follows:

“PP405 is a potent topical mitochondrial pyruvate carrier (MPC) inhibitor that acts on the cellular metabolic pathway to upregulate lactate dehydrogenase (LDH).”

Stem cells are particularly sensitive to LDH, so this results in their activation and subsequent hair growth. PP405 demonstrates a statistically significant increase in Ki67 signaling in the hair follicle bulge. Ki67 is a well-established marker of stem cell proliferation.

February 27, 2024

Pelage Pharmaceuticals Raises $16.75 Million and Phase 2 Trials to Begin in 2024

Pelage Pharmaceuticals has raised $16.75 million in Series A Financing. More importantly, they will begin Phase 2 Clinical Trials for PP405 in mid-2024.

Phase I clinical data met primary safety endpoints. And they confirm that their was statistically significant stem cell activation in hair follicles after just one week of treatment with PP405.

Per CEO Daniel Gil, Ph.D.:

“Our scientific co-founders have uncovered a unique biological mechanism with the potential to reactivate hair growth in people with alopecia.”

The company will present translational data at the American Academy of Dermatology meeting in March 2024.

Recently, reader “Ben” made an very interesting discovery on Pelage Pharmaceuticals’ website. The following sentence at the bottom:

“Early Phase I clinical data shows statistically significant stem cell activation in the hair follicles after one week of treatment with PP405.”

This is super news. So their trials have started. I wonder if PP405 is RCGD423 or UK5099? I think it sounds like that latter. The company’s website homepage describes PP405 as:

“A novel, non-invasive, topical small molecule drug platform that activates stem cells in the hair follicles directly to stimulate robust hair growth. By targeting an intrinsic metabolic switch in hair follicles, Pelage’s platform is suitable for all genders, skin types, and hair types.”

In other recent news, Pelage appointed Dr. Qing Yu Christina Weng as Chief Medical Officer.

Bioresearch Pharma BRP-011 Latanoprost Acid — Bioresearch Pharma BRP-011: Latanoprost Acid for Hair Growth.

Latanoprost Eyelash Hair Growth. Source: Nature, July 1998.

In just the past month, I covered two different companies working on a latanoprost based hair loss treatment (Canada-based Triple Hair and US-based Dermaliq). Both companies are almost certain to continue to Phase 3 clinical trials in the near future.

I also covered US-based Aneira Pharma and its latanoprost containing combination hair loss product in 2021. While the company has not updated its website for a few years, its patent application status page has been updated a few times in 2024.

Latanoprost is a prostaglandin F2α analogue eye medication that is meant to be used to treat glaucoma and ocular hypertension. It was approved for medical use in the US in 1996. An unusual side effect of latanoprost is increased and thicker eyelash hair growth. A rarer side effects is eyelash hair darkening (see image above from here).

BioResearch Pharma BRP-011: Latanoprost Acid for Hair Growth

Now comes news of BioResearch Pharma (Poland) working on a latanoprost acid based hair loss product called BRP-011. Thanks to “Ben” for posting a link to a very encouraging recent Polish magazine interview with CEO Lukasz Zybaczyński. This company was originally mentioned by “John Doe” in a comment earlier this year, and he also e-mailed me the above interview link.

According to the BRP-011 product page:

Latanoprost’s high skin penetration rate has raised concerns about potential systemic adverse side effects.
Consequently, latanoprost acid (an active metabolite of latanoprost) has emerged as an alternative option.
Latanoprost acid was initially dismissed as a potential topical treatment due to its low bioavailability.
However, BioResearch Pharma (BRP)’s chief scientific officer and co-founder Dr. Katarzyna Koziak has shown latanoprost acid to promote hair growth in a clinical setting involving indiviuals with androgenetic alopecia.

Note that BRP is only focusing on treating two conditions: androgenetic alopecia and psoriasis (via drug candidate BRP-007).

Commercialization in 2027

In the new CEO interview, the most interesting points relate to a very optimistic timeline forecast due to the nature of BRP’s products. Key quotes in bullet points (wording slightly modified by me):

BioResearch Pharma does not want to discover a new medicine and prove its safety, which usually takes years. The company intend to use an existing active substance in a new mechanism of action in a new route of administration. Regulatory agencies allow the registration of a medicine in a new therapeutic indication, using publications and data that are not the property of the applicant.
In the case of a new chemical molecule, the initial stages of the drug development process related to production and pre-clinical evaluation take around 5 to 7 years. In BRP’s repositioning process, they shorten this period to a year, relying on the past experiences of other pharmaceutical companies and patients. This method confirms safety standards.
In total, an up to 9 year process will be shortened to 2-3 years by BRP. i.e., much faster clinical trials.
In 2025, the company will begin the registration process.
The CEO anticipates commercialization after completing Phase I of clinical trials. This should happen by the end of 2026 for both projects (androgenetic alopecia and psoriasis). So commercialization in 2027.

The latter part of the interview relates to fundraising and a pending IPO.