Cassiopea's Website Updated With New Info

[fuDHTck]

They redesigned and updated the website ( https://www.cassiopea.com/ ). Nothing really new but few information:

• PH3 in man still starting in Q1 2020
• PH2 in women starting before end of the year
• 7.5% concentration chose for PH3

Yeah it might not be perfect but honestly I still hope it gets released. The more the better. And it's still not easy to judge it until we have longer data, but remember that people were still above baseline at one year. Not by a lot but still above.

 

[ZP31]

What’s their chemical again? CB?

 

[-G-]

What’s their chemical again? CB?

Yes.

 

[itsjustsimon]

So as I said, market release @ 2022-2023.

The only treatment that will actually be on the market in 2-3 years. And maybe Follica. Maybe.

 

[SamFT]

So as I said, market release @ 2022-2023.

The only treatment that will actually be on the market in 2-3 years. And maybe Follica. Maybe.

Samumed started their phase 3 last year already too. Follica will be 2021 with Samumed and CB to follow in 2022.

 

[Jimmerson]

P3074 is starting phase 3 as well.

 

[Btg]

P3074 is starting phase 3 as well.

p3074 p2 was quite disappointing tbh

 

[Mightyduck]

Samumed started their phase 3 last year already too. Follica will be 2021 with Samumed and CB to follow in 2022.

If everything goes to plan then Samumed are aiming to release in turkey late 2021. Though it wont have FDA approval for the USA, they will apply for that after if Phase 2/3 goes well otherwise they may very well do one last phase before.

 

[fuDHTck]

P3074 is starting phase 3 as well.

Phase III already finished. They are applying for approval with the FDA & EMA (or only EMA initially) very soon (Q4/19 or Q1/20).

So we should have in the next 2-3 years:

• Cassiopea with Breezula
• Samumed with SM04554
  
• Follica with their device
• Polichem with P3074

Honestly it would be already a huge milestone if all get approved. Going from 2 FDA approved products to 5 or 6 (depending how you count P3074) would be huge and would allow to create new combinations to fight hair loss.
Note that I didn't include Follicum (which I would classsify as slightly more behind and with more unknowns) or any other sketchy situation or product (looking at you Replicel)

 

[barfacan]

Isnt the acne version of CB going to be released next year? Can't we compound it to hairloss spec?

 

[Jimmerson]

p3074 p2 was quite disappointing tbh

Phase 2 results matched oral, and all they are aiming for is side free finasteride, so I wouldn't say it's disappointing.

If everything goes to plan then Samumed are aiming to release in turkey late 2021. Though it wont have FDA approval for the USA, they will apply for that after if Phase 2/3 goes well otherwise they may very well do one last phase before.

Where are you basing this off of? Not sure why they wouldn't file for FDA approval after phase III.

 

[Jimmerson]

Hard to say if sides were similar, because in trials oral has very low incidence of sides to begin with. But they did a study and after a week of p3074 it lowered serum dht a small amount compared to oral. In any case you would expect with correct dosage side effects to be lesser on topical application, especially since sexual sides are likely due to AR activity in your junk, and any mental sides due to ar activity in your brain, not actual dht levels.

 

[FilthyFrancis]

Weren't the sides similar though? So what's the point?

In 2016, they performed a 32-men study to test scalp & serum DHT (systemic DHT). With low dose topical, they were able to eliminate 50% of scalp DHT while eliminating only 25% of serum DHT (vs 70% for both scalp and serum DHT eliminated with 1 mg daily oral finasteride). However, when they pushed the concentration of the tested topical solution, they found out the impact on serum DHT was comparable to oral finasteride. From what I understand, it could be used as a safer but less effective treatment than oral fina (as a low concentration topical solution). Otherwise, there is just no point in going topical instead of oral.
I am not too hyped about this topical alternative tbh.

Here's the link to the study: https://www.ncbi.nlm.nih.gov/pubmed/26636418

 

[fuDHTck]

Polichem seems pointless unless you're scared of a pill. Cassiopea is weak, but at least it has no sides. It will be nice to have, but I doubt it will provide any real benefit on top of finasteride. That leaves Follica, Sammumed, and Shiseido as the only ones that could provide something new in the next couple years. Shiseido will require a trip to Japan, so it will be out of reach for many. I'm also looking forward to the results from Giuliani on their WAY-316606 analogue.

I wouldn't say Cassiopea (CB) is weak per se. After one year results said you would still be above baseline and 6 months results were very good. The big question is what caused the drop and does it continue or kind of stabilize?
If it stabilize then it would still be a huge win to have something which stops or significantly slow hair loss with no sides.

Regardless it can't hurt and will be super useful for people who can't take finasteride.

 

[SamFT]

If everything goes to plan then Samumed are aiming to release in turkey late 2021. Though it wont have FDA approval for the USA, they will apply for that after if Phase 2/3 goes well otherwise they may very well do one last phase before.

Thought the trial was being conducted under the standards of the FDA as well. It was going to be approved for both turkey and US. Plus samumed is based in San Diego. Why would they focus on just turkey?

 

[FilthyFrancis]

Thought the trial was being conducted under the standards of the FDA as well. It was going to be approved for both turkey and US. Plus samumed is based in San Diego. Why would they focus on just turkey?

From my understanding and based on Follicle Thought's interview of a Patient Advocacy Associate of Samumed, it was not clear whether the phase 3 trial being conducted in Turkey would support an NDA (Investigational New Drug) status with the FDA. What it means is that further data/trials could be necessary but since Samumed has not updated us since, nobody knows. In any case, the NDA status would only allow "investigational" prescription on American soil, meaning a large scale FDA approval would take more time.

EDIT: The trial, however, could support market launch in Turkey by 2022 *fingers crossed*

 

[Mr White]

CB seems to be getting mixed reviews but I'm more than willing to give it a try. Will the brand name be 'Breezula'?

 

[pegasus2]

From my understanding and based on Follicle Thought's interview of a Patient Advocacy Associate of Samumed, it was not clear whether the phase 3 trial being conducted in Turkey would support an NDA (Investigational New Drug) status with the FDA. What it means is that further data/trials could be necessary but since Samumed has not updated us since, nobody knows. In any case, the NDA status would only allow "investigational" prescription on American soil, meaning a large scale FDA approval would take more time.

EDIT: The trial, however, could support market launch in Turkey by 2022 *fingers crossed*

It's cool that something new could be available then, but honestly its efficacy is pretty underwhelming. People cling to the hope of synergistic effects with all these underwhelming treatments, but I just don't buy it. Minoxidil and Finasteride work synergistically to give great results, but they also give very good results as stand-alone treatments. I just hope people aren't waiting for Sammumed to save them.

 

[WeStayCooling]

It's cool that something new could be available then, but honestly its efficacy is pretty underwhelming. People cling to the hope of synergistic effects with all these underwhelming treatments, but I just don't buy it. Minoxidil and Finasteride work synergistically to give great results, but they also give very good results as stand-alone treatments. I just hope people aren't waiting for Sammumed to save them.

People in this section are clearly interested in future treatments BECAUSE current treatments either A) Do not work for them B) Cause side effects or C) They are not comfortable with them

I am not so sure why this is so hard for people to understand

 

[pegasus2]

People in this section are clearly interested in future treatments BECAUSE current treatments either A) Do not work for them B) Cause side effects or C) They are not comfortable with them

I am not so sure why this is so hard for people to understand

I don't know why it's hard to understand that someone can understand that but still feel bad for someone who thinks that SM is going to work for them when it's not going to give them a cosmetic improvement. I am sure there is someone out there who is afraid to take finasteride because they've heard the horror stories, so they are waiting on SM to save them thinking it's going to be as effective. Then when SM doesn't work form they will jump on finasteride after having wasted three years. It's a shame.