Category Archives: Polichem

Polichem Topical Finasteride Phase 3 Results Out

Update: June 6, 2019

It seems like P-3074 will be called ALM12845 when finally released. Per Almirall’s first quarter 2019 filings:

“The top-line Phase III results for ALM12845 (androgenic alopecia) in the EU show statistical significance for the primary end-point (Change of Target Area Hair Count) at week 24. We expect the submission in Europe of ALM12845 in Q4 2019.”

My guess is that a “submission” in Europe means the same as in the US: i.e., the company is filing for approval to sell the new drug after successful Phase 3 trial completion.

Polichem Almirall

April 19, 2019

I have covered topical finasteride (see archives) on this blog numerous different times. This despite the fact that I am far more interested in topical dutasteride.

Polichem — Topical Finasteride Phase 3 Trial Results

Earlier today, Switzerland-based Polichem (now owned by Spain’s Almirall) finally released the results of its Phase 3 trials for its eagerly awaited P-3074 topical finasteride product. This came after many months of anticipation (h/t to the guy who e-mailed me this news).

Edit: It seems like they released results in the EU last month, in a slightly different format to the US ones from today. I never wrote about this important development last month.

From what I can tell, both oral finasteride (105 test patients) and topical finasteride (48 test patients) seem to have given almost the same  results in increase in hair growth after 24 weeks.

Side effects between oral and topical finasteride also seem similar, although they are based on surveys of the patients rather than any scientific methodology.

I suppose many volunteers would drop out if they were asked to come in every couple of months for testing of erectile strength, hormonal blood tests, sperm count and so on. As it is, even in these trials, around 30 percent of subjects dropped out before the 24 weeks were over.

Most studies from the past several decades suggest very limited potential for long-term side effects from oral finasteride. If you do not believe those studies, you could still try out topical finasteride (available at most local compounding pharmacies).

No idea if Polichem will commercialize P-3074.

Encouraging Update on Polichem’s P-3074 Topical Finasteride

In my very important and popular post from last year regarding topical finasteride, I discussed Polichem’s P-3074 product. P-3074 is “vehicled” in Hydroxypropyl-Chitosan (HPCH) per the latest terminology. Past references state that it uses hydroxypropyl-chitosan (HPCH) as “film-forming agent”.  I assume both those phrases/references essentially mean the same thing.

At this year’s just completed World Congress for Hair Research in Miami, one of the presentations pertained to this very product. You can read the whole summary of the presentation within this list of abstracts from the 2015 WCHR on page 43. The key quote:

“A pharmacokinetic phase I study, tested P-3074 b.i.d. [=twice per day] vs oral finasteride 1 mg o.d. [=once per day], revealing a finasteride systemic exposure 15 times lower in the topical formulation. A pharmacodynamic study compared P-3074 b.i.d. and o.d. vs oral finasteride 1 mg o.d. in DHT inhibition in scalp (vertex) and in serum. The results showed comparable serum/scalp DHT inhibitions across formulations, suggesting that the achievement of comparable levels of DHT inhibition vs the oral form could be attained by a lower dose of P-3074.”

My note: Their older report from the 7th World Congress for Hair Research (see section titled P040) from two years ago stated that the P-3074 product is composed of 0.25% Finasteride, so the twice per day dose = 0.50% per day, which is apparently lower than 1 mg/day oral Finasteride per the implication of the last sentence in the above paragraph.

My note: They also state in the most recent abstract that at lower doses of 200 mcL, scalp DHT reduction remain unchanged, but serum DHT reduction was much lower, potentially even further limiting systemic absorption.  So 200mcL<0.50%<1mg.

Currently, P-3074 is in Phase III clinical trials in Europe.

When I called my local compounding pharmacy a few months ago to inquire about them making topical finasteride for me, they told me that while they do make topical finasteride in gel form, they only get 1 such request each year. Moreover, at around $100 per month, it is much more expensive than the cost of generic oral Finasteride.

Finally, as I mentioned in my topical finasteride post from last year, what I am really looking forward to is a topical dutasteride product with very low systemic absorption. The results from oral dutasteride are clearly superior to those from oral finasteride (make sure to read the comments to my dutasteride testimonials post). but also entail far more chances of side effects. We really need a topical version of dutasteride asap, but unfortunately this will only happen after dutasteride is officially approved to treat hair loss.

Addendum

I noticed that Dr. Antonella Tosti is listed as a consultant to Polichem as well as to Kythera in the intro to the abstract that I listed at the start of this post. Moreover, several days ago, DS Labs announced that Dr. Tosti was joining their company too as an adviser. There are perhaps 5 doctors/researchers in the world who are involved with three or more different groundbreaking companies in the hair loss research arena, and Dr. Tosti is now the newest member of this club.