Excited to hear about Phase1!!! I understand that they will release more information at the end of the month but does anyone have an idea how long until they get a Phase 2 going?

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Link to the RNS.

http://www.investegate.co.uk/summit-corporation-plc/one/summit-corp...

I have spoken to the company and am awaiting contact from Richard Pye. If I get a reply I will post it here.

Am waiting on an e-mail reply but spoke to Richard Pye on Thursday. Hopefully will be able to post again sometime this week. In the meantime this might be of interest.

http://www.treat-nmd.eu/resources/tact/introduction/

I spoke to Richard Pye last Thursday and hope to be able to post something this week.

In the meantime this might be of interest.

http://www.treat-nmd.eu/resources/tact/introduction/

I e-mailed Richard Pye regarding the TACT link in my previous post and he is apparently out of the office until the 10th of April. If I get a reply before then I will post.

Richard Pye has been very busy recently and is now attending the BIO conference so hopefully I will get a reply once he returns from this...next week sometime.

In the meantime this is the link to the summit homepage.

http://www.summitplc.com/

Go to latest presentations and click on MDA Scientific Conference for the latest presntation on DMD progress.

Hi,

So unfortunately I am still awaiting a reply...I have pestered, I have cajoled, I have enlisted other members of staff to nudge but to no avail so the following post is only my thoughts based on my conversation with Richard Pye over a month ago and the RNS`s released in the following period. Any ? marks in brackets were for Richard`s feedback which I am still waiting on. I hope it helps and makes some sense. If anyone has any questions please reply and I will do my best to answer.

 I have spoken to Richard Pye and have the following to share. The approach to the development of SMTC 1100 seems to me to be both considered and prudent.

While being confident in the compounds efficacy the company do not want to act in a way that might be seen as over-confident which could lead to advancing quicker but with higher risks attached. The recent DMD RNS and presentations highlight this approach.

http://online.morningstarir.com/ir/summ/ir.jsp?page=news-item&i...

http://www.summitplc.com/userfiles/file/201304_MDA%20poster%20April...

The development of biomarkers specific to DMD will enable the company to assess the success of the drug in more specific ways than relying solely on the 6 minute walk test and will be available for P2. (or would some testing of the biomarkers be done during P1b?)
P1b will be carried out in the latter half of the year. This will be to confirm the successful results of the P1a (?) tests carried out in healthy volunteers. It will take approximately the same time as P1a  (ten days) and will involve 15 boys. The testing will be based in the U.K.
Should this prove to be successful the first part (?) of P2 will commence most likely in the first half of 2014. This study will be for proof of concept. It will involve 30 boys. It will be based both in the U.S. and Europe. P2 will take approximately 2-3 months.  Results of data will be released shortly after this.  (is this correct Richard?)
Richard knows PPMD and the work it does and assures me he will answer e-mail enquiries as and when he can.
Though it would appear there may well be a time lag to those answers.
I will continue to badger Richard and the company to see if there is any further news I can pass on.
Best regards,
Paul

Thanks for your work and persistence on this Paul!  Please let me know if there is anything I can do to help.  Any sense of how to get our boys on a list for P1b or P2?  I'll pack my bags today... :)


paul roberts said:

Hi,

So unfortunately I am still awaiting a reply...I have pestered, I have cajoled, I have enlisted other members of staff to nudge but to no avail so the following post is only my thoughts based on my conversation with Richard Pye over a month ago and the RNS`s released in the following period. Any ? marks in brackets were for Richard`s feedback which I am still waiting on. I hope it helps and makes some sense. If anyone has any questions please reply and I will do my best to answer.

 I have spoken to Richard Pye and have the following to share. The approach to the development of SMTC 1100 seems to me to be both considered and prudent.

While being confident in the compounds efficacy the company do not want to act in a way that might be seen as over-confident which could lead to advancing quicker but with higher risks attached. The recent DMD RNS and presentations highlight this approach.

http://online.morningstarir.com/ir/summ/ir.jsp?page=news-item&i...

http://www.summitplc.com/userfiles/file/201304_MDA%20poster%20April...

The development of biomarkers specific to DMD will enable the company to assess the success of the drug in more specific ways than relying solely on the 6 minute walk test and will be available for P2. (or would some testing of the biomarkers be done during P1b?)
P1b will be carried out in the latter half of the year. This will be to confirm the successful results of the P1a (?) tests carried out in healthy volunteers. It will take approximately the same time as P1a  (ten days) and will involve 15 boys. The testing will be based in the U.K.
Should this prove to be successful the first part (?) of P2 will commence most likely in the first half of 2014. This study will be for proof of concept. It will involve 30 boys. It will be based both in the U.S. and Europe. P2 will take approximately 2-3 months.  Results of data will be released shortly after this.  (is this correct Richard?)
Richard knows PPMD and the work it does and assures me he will answer e-mail enquiries as and when he can.
Though it would appear there may well be a time lag to those answers.
I will continue to badger Richard and the company to see if there is any further news I can pass on.
Best regards,
Paul

Hi Keith and Jill,

Good to hear from you and so quickly too. May I ask where you are based?

Best regards,

Paul

I too am hoping to learn the location of US sites as soon as it is known...thank you again for posting to this board I will do same if other information sources hear something

Hello again,

I have just found out that Summit will be attending the PPMD Connect Conference this month on the Saturday presenting in the afternoon at 2.00 Presentation by Jon Tinsley. There is a Q & A but am not sure who will be taking questions...all the speakers prior to the Q & A seems most likely but...

Summit also had their AGM today.

This is the SMT C1100 relevant part from the Chairmans statement.

"In our utrophin modulator programme for the treatment of DMD, the most common and severest form of muscular dystrophy, our lead drug candidate SMT C1100 successfully completed a Phase 1 clinical trial in healthy volunteers. Data from the trial showed that SMT C1100, a potential treatment for all genetic forms of DMD, was safe and well tolerated. In addition, all the volunteers who received repeat doses of SMT C1100 achieved blood plasma concentrations of the drug that are expected to confer therapeutic benefit based on the data generated in non-clinical activity studies. This key data represents validation of the new formulation and is an important step-forward for the programme.

"We are now preparing to take the major step of advancing SMT C1100 into the first ever patient clinical trials of an utrophin modulator drug. Summit is now engaging with the EU and US regulatory authorities as we finalise our clinical plans. We are working with a new contract manufacturer to make drug product for use in future clinical trials and long-term toxicology studies. We are working with leading scientists to develop new biomarkers that will be used to evaluate the benefits of SMT C1100 in patient trials. This work is being supported by our growing clinical development team and programme advisory board that comprises world-leading scientists and clinicians in the field of DMD. We expect that the first patient clinical trial will start in H2 2013 with a Phase 2 activity trial to follow in 2014."

Hope some of you can make it.

Best regards,

Paul

Good aternoon all,

The link below is to a recent review on SMT C1100 from TACT. Definition below for those who haven`t heard of TACT.

TACT, the TREAT-NMD Advisory Committee for Therapeutics, is an expert multidisciplinary body that provides the neuromuscular community (clinicians, researchers, patient advocacy groups and industry) with independent and objective guidance on advancing new therapies (whether novel or repurposed) for neuromuscular diseases.

The link covers an overview of SMT C1100 and what advice TACT has made to ensure the programme moves forward hopefully to a successful conclusion. Jon Tinsely`s name appears so if any of you are attending the PPMD conference you could ask him a few questions to follow up.

http://www.treat-nmd.eu/resources/tact/reviews/past/smt-c1100/

Best regards,

Paul

Good morning all,

I thought this might be of interest last updated about three weeks ago so may not be "new" news to some.

hxxps://www.duchenneconnect.org/index.php?option=com_content&view=article&id=380%3Asmt-c1100-a-small-molecule-utrophin-upregulator-for-dmd&catid=80%3Astudy-notices&Itemid=472&lang=en
the last paragraph follows.
Where will the trial take place? Will there be study sites in the US?

The Phase 1b dose finding and safety trial is expected to be located in the UK. The Phase 2 trial is expected to be an international study and is likely to include sites within Europe and also the US, although these plans are still to be finalized and remain subject to review by the various regulatory authorities and other experts.

Where can I learn more about SMT C1100?

You can learn more at www.summitplc.com. www.ClinicalTrials.gov will post the next phase of patient trials as soon as they are recruiting. Please check www.DuchenneConnect.org for updates to this FAQ sheet.

(Updated 6/6/2013)
Best regards,

Paul

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