Intrepid Therapeutics tests drug to cure baldness, acne

[Pate]

So this treatment is like 10 years away....

Probably not that long. Cosmo has been looking at 2015 for the acne treatment and 2016 for the hair loss treatment. With the inevitable timeline creep it's probably 2017 at the earliest, but that's five years away rather than ten.

After Histogen and Replicel, this is the treatment I'm most looking forward to. If it's as effective as the initial trials indicate it should become the new first-line treatment for MPB and consign Propecia to the scrap heap. No systemic effects and only needs to be applied once or twice a week.

The only thing I'm worried about is that they might struggle to attract investors/partners to develop it if the investors are worried Replicel etc will make them obsolete. Which won't happen - even if Replicel is fully effective (and that's a huge IF) there will still be a market for CB-03-01 in prevention of hair loss and maintenance of stuff like Histogen. I'd rather not lose my hair in the first place than need to have Replicel or Histogen at all!

[VictimOfDHT]

Oh thank God, another FUTURE treatment. Man, we have dozens upon dozens of potential FUTURE treatments that the present never seems to catch up with. Fast forward another 10 years and we'd probably still be reading headlines with similar shit.
Ehhhhh, only if I could say wake me up when the future (and the treatment) is here.

[Pate]

Oh thank God, another FUTURE treatment. Man, we have dozens upon dozens of potential FUTURE treatments that the present never seems to catch up with.

I understand your frustration but I don't think you can lump CB in with all those other stagnant treatments. There are very few hair loss drugs actually actively being developed, which is something Cosmo have pointed out in some of their presentations.

If you take out the snake oil and just look at drugs actually in clinical trials there is pretty much just Latisse and Avodart I think. And after what's happening with Fin I have my doubts Avodart will ever be seriously marketed for hair loss, since it's even more potent than Fin. Astressin-B is supposed to be starting clinical trials soon, and then there is ASC-J9 and CB-03-01. ASC doesn't seem to be going anywhere fast which is a pity because it could be a very powerful drug against MPB.

And that's pretty much it as far as I'm aware. The others, RU, NEOSH etc, I don't think will ever be developed. We should be grateful that in Cosmo we have a company that is apparently interested in pushing ahead with a drug for MPB, because that seems to be what's really been lacking. Of course it may still fall by the wayside like so many others have, but at least it's not being sat on by an uninterested company while the patent expires.

But I know what you mean. I won't really believe in CB-03-01 until I have the first bottle in my hand.

[Pate]

Another CB-03-01 update:

Cosmo Licenses Its Anti-Androgen for Certain Topical Applications

Lainate, Italy – 2 April 2012 – Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today announced that it has signed a license agreement with a leading U.S. public pharmaceutical company granting it exclusive world-wide rights for the development and commercialization of Cosmo’s new chemical entity CB-03-01, an investigational anti-androgen drug targeted at certain topical skin applications.

The license agreement provides for the payment of $25 million up-front, regulatory and commercial milestones and royalties on sales averaging those of other commercial transactions.

Mauro Ajani, CEO of Cosmo Pharmaceuticals, commented: “I am very proud of this agreement because we have partnered with one of the world’s leading specialty pharmaceutical companies. This is a very important next step in pursuing approval for this product.”


This is potentially BIG for CB-03-01 and Cosmo. No indication of who the company is, I guess it's still confidential, but this is a different announcement from the agreement with Intrepid.

$25M is a big payment up-front for a small company like Cosmo, plus royalties. Somebody is obviously serious about this drug, and since there are literally dozens of acne drugs on the market, I'm guessing it's the hair loss side they are most interested in.

Of course, this won't stop the whiners whining about it still being five years away, but oh well. This has the potential to send finasteride to the scrapheap, and become the new first-line drug therapy and to work in combination with stuff like HSC, and unlike most of these half-hearted attempts to develop new treatments, Cosmo actually seem really serious about this.

I'm also expecting the conspiracy brigade to bring up that Merck might be the buyer and might have done it to kill CB-03-01 so that it doesn't affect their Propecia sales... so to head that one off at the pass, I'll point out the Propecia patents expire soon. The only way Merck is going to stop losing their sales to generics is if they can develop a drug under patent that is a significant improvement over Propecia.

[2020]

Another CB-03-01 update:

Cosmo Licenses Its Anti-Androgen for Certain Topical Applications

Lainate, Italy – 2 April 2012 – Cosmo Pharmaceuticals S.p.A. (SIX: COPN) today announced that it has signed a license agreement with a leading U.S. public pharmaceutical company granting it exclusive world-wide rights for the development and commercialization of Cosmo’s new chemical entity CB-03-01, an investigational anti-androgen drug targeted at certain topical skin applications.

The license agreement provides for the payment of $25 million up-front, regulatory and commercial milestones and royalties on sales averaging those of other commercial transactions.

Mauro Ajani, CEO of Cosmo Pharmaceuticals, commented: “I am very proud of this agreement because we have partnered with one of the world’s leading specialty pharmaceutical companies. This is a very important next step in pursuing approval for this product.”


This is potentially BIG for CB-03-01 and Cosmo. No indication of who the company is, I guess it's still confidential, but this is a different announcement from the agreement with Intrepid.

$25M is a big payment up-front for a small company like Cosmo, plus royalties. Somebody is obviously serious about this drug, and since there are literally dozens of acne drugs on the market, I'm guessing it's the hair loss side they are most interested in.

Of course, this won't stop the whiners whining about it still being five years away, but oh well. This has the potential to send finasteride to the scrapheap, and become the new first-line drug therapy and to work in combination with stuff like HSC, and unlike most of these half-hearted attempts to develop new treatments, Cosmo actually seem really serious about this.

I'm also expecting the conspiracy brigade to bring up that Merck might be the buyer and might have done it to kill CB-03-01 so that it doesn't affect their Propecia sales... so to head that one off at the pass, I'll point out the Propecia patents expire soon. The only way Merck is going to stop losing their sales to generics is if they can develop a drug under patent that is a significant improvement over Propecia.

yeah this won't take 5 years... At most maybe 2 years.

Anyways, they're targeting acne market at the moment, so whatever product they'll come up with will probably be too weak to use against MPB...

[clandestine]

obviously it regrows hair or they wouldnt take time and money to develop it

No. This is not obvious. Preventative measures are indeed necessary when considering hairloss treatments.

[Pate]

yeah this won't take 5 years... At most maybe 2 years.

Anyways, they're targeting acne market at the moment, so whatever product they'll come up with will probably be too weak to use against MPB...

3 years for the acne treatment was the original prognosis, 4 years (ie 2016) for MPB... but it'll be interesting to see how that might change with the Phase II now locked in and the power of this mystery 'major pharmaceutical' company behind it. It could be fast-tracked. Cosmo didn't have the resources to develop it themselves.

Here's hoping, anyway!

The POC study did regrow some hair but it's not a growth stimulant so I think the main value will be in maintaining what you already have. Modest regrowth at best. Combine it with Histogen and we will (hopefully) all be hirsuite ladykillers again...

[Gjm127]

If it's not a stimulant, then what is it?

[gmonasco]

CB-03-01, a molecule patented by Cosmo, is a steroidal ester, androgen antagonist derived from 11-deoxycortisone, which tightly mimics the profile of an ideal anti-androgen for topical use.

The objective is to create a product for topical application to treat acne, male pattern baldness, and seborrhoea that does not have the side effects of products currently being taken in tablet form.

An IND was filed in the US for CB-03-01 for acne. Clinical trials are planned to start in the USA in Q2 2012.

http://www.cosmopharmaceuticals.com/activities/pipeline/cb.aspx

http://www.bloomberg.com/apps/news?pid=conewsstory&tkr=CQ1:GR&sid=apTE0BEalKQs

[Gjm127]

http://www.cosmopharmaceuticals.com/...peline/cb.aspx

http://www.bloomberg.com/apps/news?p...d=apTE0BEalKQs

So this means they're entering phase 1 this May. So we're 8-10 years away?

[Pate]

No, they're entering Phase II for acne. The alopecia product is about 12 months behind the acne product from the look of their presentations.

As I already said in the post you must have read because you replied to it, "3 years for the acne treatment was the original prognosis, 4 years (ie 2016) for MPB."

The licensing news is a big positive because whoever this big pharma company is, they will have deep pockets so development shouldn't stall through lack of funds.

And it's not a growth stimulant, it's an anti-androgen. But in the POC study it showed regrowth that I'd say is better than Propecia. Which is not surprising, Propecia only lowers scalp DHT by something like 30% if I recall correctly. This stuff should comfortably beat that figure, while still leaving our serum DHT where it should be!

[Sogeking]

No, they're entering Phase II for acne. The alopecia product is about 12 months behind the acne product from the look of their presentations.

As I already said in the post you must have read because you replied to it, "3 years for the acne treatment was the original prognosis, 4 years (ie 2016) for MPB."

The licensing news is a big positive because whoever this big pharma company is, they will have deep pockets so development shouldn't stall through lack of funds.

And it's not a growth stimulant, it's an anti-androgen. But in the POC study it showed regrowth that I'd say is better than Propecia. Which is not surprising, Propecia only lowers scalp DHT by something like 30% if I recall correctly. This stuff should comfortably beat that figure, while still leaving our serum DHT where it should be!

Here's hoping. And not just for MPB, but for acne too, in my case atleast .