Update: Official announcement published on July 16. Better results than Minoxidil, and very optimistic statements regarding pursuing final clinical trials:
- DLQ01 treatment increased total area hair count (TAHC) by 12.3% from baseline.
- 83% of subjects responded with a positive increase in hair growth.
- The comparator drug minoxidil increased TAHC by 9.8% from baseline.
Still no mention of Latanoprost. They just say that DLQ01 is a prostaglandin F2α analog, based on Dermaliq’s novel hyliQ® technology. The latter enables targeted rapid delivery of active ingredients into hair follicles.
July 15, 2024
Dermaliq Therapeutics DLQ01: Phase 2 Clinical Trials Successful
I first mentioned Dermaliq Therapeutics in a 2022 update to my 2020 post on increasing prostaglandin E2 (PGE2) and prostaglandin F2α (also called PGF2α or PGF2 alpha) for hair growth. The US-based privately-held company is working on a topical Prostaglandin F2α analogue hair growth product called DLQ01 (thought to contain latanoprost). It is based on Dermaliq’s novel and proprietary platform technology called hyliQ®.
The company claims that hyliQ “offers cutaneous drug delivery with unmatched bioavailability for a wide range of pharmaceutical actives”. In 2022, Dermaliq started Phase 1b/2a clinical trials for DLQ01 at Sinclair Dermatology in Melbourne, Australia. This clinic is run by the renowned dermatologist Dr. Rodney Sinclair, who I have written about numerous times in the past.
Earlier today, reader “John Doe” found an update on Dermaliq’s pipeline page which suggests that Phase 2 trials are finished and the results were very good. See the above screenshot. It says the following:
“DLQ01 Phase 2 data has impressively demonstrated its superior efficacy. The number of hairs in the target area increased effectively with high statistical significance compared to the vehicle. More than 80% of subjects responded with a positive change in hair growth. We are continuing clinical development based on a clear regulatory pathway to approval.”
To me, this signals that Phase 3 clinical trials are now a certainty. The company’s news page has not been updated since December 2022, but I suspect that this will change soon.
Note that DLQ01 is said to grow hair in both men and women suffering from androgenetic alopecia (aka male and female pattern baldness). According to Dr. Betsy Hughes-Formella (Chief Scientific Officer at Dermaliq):
“Dermaliq’s hyliQ® technology has the potential to transform follicular and dermal delivery of a broad range of active ingredients. DLQ01 is just the start of a promising pipeline targeting follicular delivery.”
Prostaglandin F2α Analogue Latanoprost
Prostaglandin F2α analogue Latanoprost has already proven to grow eyelash hair longer and thicker. Latanoprost (brand name Xalatan) is a medication that is meant to be used to treat glaucoma and hypertension in the eyes. It was approved for medical use in the US in 1996. The eyelash hair growth (and darkening) was a notable side effect.
Several companies are developing combination hair growth products based on Latanoprost. The most promising of these is Triple Hair (Canada), which is on the verge of commencing Phase 3 clinical trials. Another company called Aneira Pharma (US) does not seem to have updated it website for several years. However, the company’s hair growth related patent applications are still being updated as of 2024 (h/t “John Doe”).
It is strange that on its website, Dermaliq does not mention that DLQ01 contains latanoprost.
https://innovation.uci.edu/news/amplifica/
News Amplifica
I like the 80% response rate but it will be interesting to see what “incresed effectively” turns out to actually mean. I also like that it is an arguably new method of action. I also find it interesting that the first subject was dosed in December of 2022 and here we are in H2 of 2024. Meanwhile Pelgae announced the read out of their Phase 1 in March of 2024, and have already started their Phase 2 trial. I don’t know if that has to do with the relative efficiency of the companies, the capital resources they have at their disposal, or what. Perhaps it means don’t conduct a clinical trial with Rodney Sinclair………the Phase 1 for HMI-115 started in May of 2022 and was completed in September of 2023.
Well as far as I see it, Dermaliq finished phase 1, 2a and 2b in under 20 months, which is lightning-fast.
Pelage phase 1 was done during 2022 by the way, and 2 was started approximately two years after phase 1. They are definitely not fast and they also lost a good two years because of lack if funding.
Thanks, was waiting for someone to do this analysis
Ben, The Dermalique trial was actually just 1 clincial trial that was a combined phase 1 and phase 2, not 3 trials as far as I can tell: (https://clinicaltrials.gov/study/NCT05636904?viewType=Table&cond=Androgenetic%20Alopecia&term=dermaliq&rank=1). I have not seen a combined study like that before but also don’t know much about how that works. The Dermaliq trial started on 12/5/2022 and completed on 3/28/24. It lists as a 24-28 week assessment time frame so not sure why it took so long. I had all but given up on Pelage until the release of their phase 1 results this spring. But I believe they are moving very fast now and have stated that clincial trials for hair are quick to enroll and complete. I assumed their slow start had to do with funding and the issue related to the option given to Allergan that was eventually terminated. Oddly, I don’t see the phase 1 trial on clincial trials.gov but from what I can tell, the phase 1 trial was condcuted in the fall of 2023: https://medcitynews.com/2024/02/hair-loss-drug-regenerative-medicine-ucla-startup-pelage-gv/#:~:text=The%20Phase%201%20study%20conducted,twice%2Ddaily%20application%20were%20tested.
Now they published the News ….
https://dermaliq.com/2024/07/dermaliq-therapeutics-announces-positive-topline-results-from-phase-1b-2a-trial-evaluating-the-safety-and-efficacy-of-dlq01-for-the-treatment-of-androgenetic-alopecia-aga-in-men/
Great find again…no news regarding a phase 3 though.
Admin, your interpretation of the data?
Better than Minoxidil results is very impressive if it is just Latanoprost.
The statements in the article are all very optimistic.
Would be helpful if they gave results in terms of TAHC/mm2, as it’s hard to really get an objective measure for comparing treatments with % figures. That said these results seem quite lacklustre. Stem cell manipulation definitely seems the way to go until hair cloning is solved.
Yes I kinda agree, it’s confusing. The TAHC should always be what it says: hair count. No percentage. That said, als a hair count is relative to the hair being present prior to treatment.
The sole numbers seem underwhelming to me too, but as Admin says the statements of the company are almost enthusiastic – could be just marketing talk. I‘d like to see pictures.
Although if it really is better than topical Minox then it is indeed a pretty good treatment – Minox can have convincing results.
Eager to see detailed results from the trial – I am fairly optimistic for this one, but I doubt it’s a cure (as they claim).
I don’t see much to get excited about. If you had 10 hairs in the target area before treatment, you’ll have 12 hairs after treatment. Many of us need dramatically better results.
Are any of these company’s taking participants for their next trial?
Both the added statistical details and especially the statement about accelerating their efforts are encouraging. I don’t disagree that the results seem “lacklustre”, especially if you don’t have much hair to save. However, given that this is a treatment they describe as having a “new mode of action”, I think it has the potential to provide beneficial results (for those of us who have tried just about everything) while newer forms of DHT or androgen receptor suppression may not. I am “out of ammo” so I would certainly welcome a replacement of minox with this in my stack.
Any word on whether the side effects profile will be similar to bimatoprost etc? The thing about changing eye colour strikes me as so utterly invasive.
Agree, though discoloration is a major concern, it may actually indirectly address the grey hair issue (provided no skin staining…). more clinical data to be seen.
Any info on the strengths of latanoprost in these formulations? Aneira or Dermaliq.