Where are the phase IIb results for Bimatoprost?

[PinotQ]

Sorry....not sure how I missed all of that!

Page 58 bud.

[JayM]

I don't recall anyone posting on the latest trial results but I saw this yesterday: http://www.hairlosscure2020.com/category/allergan/
The first R&D presentation PDF, on page 17, describes the results as "still early but positive results". I assume this is the latest trial as it posts results for Bimatoprost 1% & 3%. The results are a bit inconclusive as the Subject Self Assessment for minox is higher than for either 1% or 3% bim but the Expert Panel and Global Assessment is higher for Bim....by an estimated 10% to 20% (the graph is not detailed) over minox.
Not earth shattering but it looks like they plan to move forward as further studies are planned.

Page 58 bud.

[PinotQ]

I don't recall anyone posting on the latest trial results but I saw this yesterday: http://www.hairlosscure2020.com/category/allergan/
The first R&D presentation PDF, on page 17, describes the results as "still early but positive results". I assume this is the latest trial as it posts results for Bimatoprost 1% & 3%. The results are a bit inconclusive as the Subject Self Assessment for minox is higher than for either 1% or 3% bim but the Expert Panel and Global Assessment is higher for Bim....by an estimated 10% to 20% (the graph is not detailed) over minox.
Not earth shattering but it looks like they plan to move forward as further studies are planned.

[Keki]

Thanks for the info.

BTW, i just checked here the dosage. Itīs 0.005% and not 0.03%.

Latanoprost can improve minox, they are not the same, we actually don't know well how minox works at all, i've seen some pics of a doc which prescribed latanoprost to a minox user and it actually improved a little, but you have to be extremely lucky with that dosage, i think the minimum amount to hope for some hairs back are 0.1% or more, extremely expensive, we need to wait bim for something more stable in the results and mass produced

[Paul73]

They work by the same or similar mechanism, so I doubt using both would be of any benefit.

Thanks for the info.

BTW, i just checked here the dosage. Itīs 0.005% and not 0.03%.

[unbalding]

They work by the same or similar mechanism, so I doubt using both would be of any benefit.

[Paul73]

It is equivalent, but don't waste your money. It's .03%, which is useless. It looks like 1% is the sweet spot, but that would be a huge waste of money for something that is no better than minoxidil.

Thanks for the answer, unbalding. Well, i thought that maybe latanoprost could be used together with min. So they would have a synergy effect. By the way, many places sell a foam compounding of Latanoprost and MIn.

I didnīt know the results were weaker than minoxidil. I already use minoxidil for 20 years, i was hoping that latanoprost could help to improve minoxidil results.

[unbalding]

Hello guys,

Please, whatīs your opinion on latanoprost? Do you think it could give similar results to Bim? I know we donīt have enough info about Bim., but many local pharmacies here in Brazil are already selling latanoprost. So at least the safety of the formula seems to be proven.

Should i give it a try? Let me know your thoughts. Thanks!

It is equivalent, but don't waste your money. It's .03%, which is useless. It looks like 1% is the sweet spot, but that would be a huge waste of money for something that is no better than minoxidil.

[Paul73]

Hello guys,

Please, whatīs your opinion on latanoprost? Do you think it could give similar results to Bim? I know we donīt have enough info about Bim., but many local pharmacies here in Brazil are already selling latanoprost. So at least the safety of the formula seems to be proven.

Should i give it a try? Let me know your thoughts. Thanks!

[lacazette]

Regarding Bim, there's also the japanese equivalent developed by R-Tech Ueno

RK-023 (Nobiprostlan), an eyeleash drug tested for alopecia

In their pipeline from June 2015, RK-023 was about to enter phase2b and was 'open to license' ("RTU is aiming to make profit early by license or joint development")

http://rtechueno.com/en/company/busi...ness.html#rd09 (scroll to the middle for the pipeline)

so maybe it's another company now that continue the trials, or maybe they are in a joint development

[Hemo]

Can someone illuminate me on phase 2b trial vs going into phase 3 and what could be the possible timelines to release in downside base and positive scenarios?

I think it's a combination of dosage and delivery. It sounds like the "enhanced" version is more than just a higher dosage, so they likely have to test it before moving onto phase 3. I guess it's a good sign they're confident enough that the new formula will work/be better to put it through a trial.

[rdawg]

Can someone illuminate me on phase 2b trial vs going into phase 3 and what could be the possible timelines to release in downside base and positive scenarios?

basically bumps it back a year, my guess is there are regulations where they cant just test a higher dose at phase III, they have to do a phase IIb all over again.

They've shown it works to an extent at 1% but 3% has shown to be even better.

timeline wise, if it went straight to phase III, we're talking Q1 2017 release, but since it's going back to phase IIb(and i find it near impossible they dont find what they are looking for this time) most likely a Q1-2 2018 release at best, Q4 2018-Q1 2019 at worst.

The positive news is they believe it works, I doubt a company would truly invest this much money and time into something they dont plan on pushing forward, they really want to maximize it's efficacy and possibly pair it with SETI. It's effective, it just needs to be perfected. Be happy we're talking 2-3 years at most!

[cocacola]

Can someone illuminate me on phase 2b trial vs going into phase 3 and what could be the possible timelines to release in downside base and positive scenarios?

[Hemo]

Eh, sounds to me like they're just putting it off until it can be tested/released alongside seti.

[It's2014ComeOnAlready]

I would think that would be extremely expensive, I recall people saying 0.1% was very costly, you'd have to be rich to afford 3%.(similar problem with CB being tested at a high dose but would be more than a HT to test on the grey market).

in regard to your first point, it seems clear they know the dose they need to aim for now and just need to perfect it(although it's annoying that this cant be tested out in a phase III, just adds an extra year) so there's nothing negative to be taken from here. Seti is promising as it's already been tested in a Phase I by over 1000 respondents, and can likely be fast tracked within 3-4 years.

I think the key to take from this is, BIM is coming out(and likely SETI as well), it's just finding the perfect dose. We're not in a 5 year range here anymore, more of a 2-3 year timeframe until we get at the very least an alternative to minox(and for many, this may work for people where minox didnt!).

These are all positive takeaways, and they are logical. Not over-speculation, not overly negative or positive. The truth is that we have a few treatments that are close, and hopefully the 21st Century Cures Act will help speed things up with all three. It's very likely it will, and Samumed at least has biomarker and surrogate endpoint data to support an alternative phase 3. Not to forget that Seti has conducted 8 clinical trials, with excellent safety data. Bim has also showed effectiveness AND safety in their trials.

imo it's a game of t-ball, fellas. It's sitting right there to be knocked out of the park. Great things for all of us will be here very soon. Hold on.

As far as the bill goes, the senator authoring the bill (Lamar Alexander) based on the one passed in congress, has previously published a few papers advocating for the FDA to speed up their trials and use biomarker and surrogate endpoint data. AND the new FDA chief, Dr. Robert Califf, installed by Obama has also written papers calling for the same.