Kythera and Replicel Updates

Replicel’s latest presentation from BioAsia 2015 in Japan is out.  I was not planning on writing much about Replicel for a few months, but it seems like they keep making interesting presentations almost every month with some new information each time. Moreover, people in the hair loss chat on this site keep asking about Replicel.

At the start of the presentation, I liked reading the quote from Japanese prime minister Shinzo Abe that was made in early 2014:

Japan is on the leading edge in regenerative medicine. We will make it possible to generate cells at private-sector factories.

Page 16-19 has most of the RCH-01 and 6-month hair growth related information.  12-month results with higher doses and frequency will likely lead to better outcomes as has been conjectured in the past.  The last part of the presentation has more details on Japan’s regenerative medicine reforms (via Abenomics related policy changes) and early-to-market reforms.

More interesting to me was this week’s news regarding Kythera Biopharmaceuticals’ ATX-101 injectable drug that reduces double chins receiving unanimous backing from an independent panel of experts.  It is thus likely that the FDA will approve this product in the next several months, and if effective, it could in some cases become a better alternative to liposuction.  In fact ATX-101 (brand name Kybella) would be the first ever drug to be approved by the FDA to reduce localized fat deposits.  This company’s stock price movement is definitely worth following.

The main reason I found this news interesting is because just over a month ago, Kythera Biopharmaceuticals acquired global rights to Setipiprant, a PGD2 antagonist.  According the company’s highly informative 2013 annual report and per various parts of the company’s website, it seems like hair and fat are two of the main areas in which Kythera will be focusing on in the coming years, with an overall focus on the human face.  The company has a long-term goal of becoming a major player in the aesthetics industry.

For those interested, Kythera has an investor conference call and webcast later today at 4:30 pm ET.

14 thoughts on “Kythera and Replicel Updates”

  1. Seriously? Did u just say that? Kythera aquired the right to a compound which has been pn the market for years.. And no mention of hair growth or halting hairlossbwas ever mentioned.. There are so many reasons to buy the rights without having major plans at all. Please hold on untill u they actually move from hypothetic scenarios into real world clinical trials.

    1. Do a little googling first…

      This was backed by UPenn and Dr Cotsarelis, one of the leading hair loss experts. It’s supposed to target one of the key pathways in AGA. It failed asthma trials and they are going to try to get it approved for hair loss instead.

  2. Replicel talks a good game but with them it is basically delay of game. If they are for real this cure for baldness will probably be in Japan first under Shiseido. Shiseido has been around for a very long time & have a good track record. Replicel is fairly new. So with all these people buying stock BEWARE!!!

  3. Setipiprant is being examined for hairloss. Okay, but if it worked wouldn’t we have heard something about hair growth from the asthma trials? When fin was first introduced word spread that it helped with hairloss which is why Spencer from tbt jumped on it. If Sep has a hair promoting effect wouldn’t word have spread quickly, especially now with the internet? …also doesnt cotsarelis have a hairloss company thst supposedly made major break throughs several years ago that has yet to amount to anything?…grab ten balding guys, throw some septiprat on their heads for a few months and take it orally and see if anything happens??! All this”we believe it will help with hair growth” qoutes is bunk. Actions speak louder then words and I for one am tired of the games.

  4. RepliCel never stated they would use a higher dosage. David Hall stated the opposite in an interview with Spencer. He stated they would dose down.

    It was put forward on HairSite back in 2012, that RepliCel may have a biphasic response curve. The more DSC cells replicated, the less inductive, and the less response. That would explain why they are dosing down. This is also were the frequency comes into play. They are probably taking a fresh biopsy, thus a new set of fully inductive DSC cells to culture.

  5. Replicel clearly states “to clarify pricing & dosage” in their phase II hair restoration which is taking forever to get started by the way. Hopefully, when phase II is completed; phase III will be skipped and this finally be on the market!!!!!!!!!

  6. The thing why I believe in Kythera is that it can be a permanent cure and Replicel isn’t !!! Kythera has been working for 2years now and as I saw on the web, they are planning phase 2 later this year, let’s see what happen, we never know, we can be surprised!

  7. Is follicept out of the picture already? I thought their testing was going to be complete in this fall but their website, hairgrowthsoon.com, doesn’t exist anymore.

  8. De Replicel vayan olvidandose! Shiseido inicia fase 2 recién fines de este verano con mucha suerte. Estará en el mercado 2018 o 2019, solo en japón. En el resto del mundo para dentro de 10 años!!! me lo respondieron ellos mismos. Saludos.

  9. y por que hay que olvidarse gabriel? replicel supuestamente solo necesita una injeccion para efectos permanentes donde se convertiran todos los pelos de la cabeza en los mismos que los de atras y los laterales..(osea,, inmunes al dht)… solo require que se viaje a japon… para hacer el tratamiento y listo..

  10. Primero que todavía eso que vos estás comentando es algo que todavía no está probado. Puede llegar a fallar. Y todavía no han iniciado fase 2. Shiseido recién podría iniciar fase 2 agosto de este año. Hasta que recluten a la gente y luego hagan todas las pruebas, los resultados estarían recién finales del 2017. Hasta que salga un producto al mercado en japón no creo que sea antes del 2018 o 2019. Siempre se demoran.

  11. por eso puse “supuestamente”.. pero que nadie niega que minimo tardaran otros 5 añitos en sacarlo… pero eso de que no nos esperemos que salga para nosotros en 10 años.. lo dudo.. si funciona de maravilla.. saldran miles de empresas que se dediquen a comercializar el producto y la cirugia en otros continentes .

  12. En japón puede salir en el 2019. Pero eso va a estar disponible unicamente ahí, ya que va a estar a prueba con las nuevas legislaciones. Replicel por su parte va a demorar 10 años en sacar un producto al mercado, falta la fase 2 y fase 3.

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