Summit Therapeutics Share Discussion Threads

[chrisatrdg] 03/10/2018 15:14

Todays RNS

Summit Therapeutics plc - SUMM
Summit Highlights Phase 3-Ready Precision Antibiotic Ridinilazole at IDWeek 2018
Released 12:00 03-Oct-2018

Summit Therapeutics plc
(‘Summit’; or the ’Company’;)

Summit Highlights Phase 3-Ready Precision Antibiotic Ridinilazole at IDWeek 2018

Ridinilazole in Development to Treat C. difficile Infection and Reduce Recurrent Disease
Oxford, UK, and Cambridge, MA, US, 3 October 2018 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic innovation, is highlighting ridinilazole’s potential as a front-line treatment for C. difficile infection (‘CDI’) in a series of oral and poster presentations at the infectious disease conference IDWeek 2018 in San Francisco, CA. Ridinilazole is the Company’s most advanced new mechanism antibiotic, which is expected to enter Phase 3 clinical trials in the first quarter of 2019.

As are being outlined at IDWeek, the Phase 3 clinical trials of ridinilazole are designed not only to evaluate ridinilazole in the treatment of CDI but also to show its impact on reducing disease recurrence and in preserving the gut microbiome, important determinants of public health impact. The effectiveness of ridinilazole in the treatment of CDI and CDI recurrence will be evaluated by measuring sustained clinical response (‘SCR’), which is the primary endpoint for both of the two planned Phase 3 clinical trials.

“We believe that to have success in antibiotics, we need to be bold and think differently. This is highlighted by our Phase 3 clinical trial design for ridinilazole that aims to show superiority of ridinilazole over vancomycin, the current standard of care. The primary endpoint will measure how ridinilazole can treat CDI and reduce recurrent CDI, the major unmet need in this disease. Finally, we are incorporating health economic outcomes measures that we believe will help support premium pricing,” commented Dr David Roblin, President of R&D of Summit. “If the Phase 3 clinical trial results are positive, we believe these measures would differentiate ridinilazole in CDI and support its front-line use.”

A summary of the information being presented at IDWeek includes:

Ridinilazole achieving statistical superiority over vancomycin in the primary endpoint of SCR in a Phase 2 clinical trial called CoDIFy; this superiority was driven by a large reduction in CDI recurrence.
Ridinilazole significantly preserved the gut microbiome of patients with CDI in CoDIFy, which Summit believes led to the reduction in recurrent CDI.
The design of the ridinilazole Phase 3 clinical trials called Ri-CoDIFy which will use the same primary endpoint of SCR.
Ridinilazole’s activity is targeted to the site of infection. Preclinical studies and Phase 1 and 2 clinical trials of ridinilazole have shown negligible systemic exposure and levels of drug in the colon and/or faeces significantly above the minimum inhibitory concentration.
A good safety profile with ridinilazole, being generally well tolerated in prior clinical trials and non-clinical studies.
Ridinilazole was significantly more potent against over 500 recent clinical isolates of C. difficile than vancomycin and metronidazole, another commonly used CDI treatment, regardless of ribotype or antibiotic resistance profile.
Diagnostics are important for selective antibiotics, such as ridinilazole, to ensure patients are treated with the right drug for their infection. As was used in CoDIFy, a test for the toxins produced by C. difficile will also be used in the Phase 3 clinical trials to confirm that patients have CDI.
Copies of the presentations are available under the Publications section of Summit’s website, www.summitplc.com.

About C. difficile Infection
C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly in the wider community with over one million estimated cases of CDI annually in the United States and Europe. CDI is caused by an infection of the colon by the bacterium C. difficile, which produces toxins that cause inflammation and severe diarrhoea, and in the most serious cases can be fatal. Patients typically develop CDI following the use of broad-spectrum antibiotics that can cause widespread damage to the natural gastrointestinal (gut) flora and allow overgrowth of C. difficile bacteria. Existing CDI treatments are predominantly broad-spectrum antibiotics, which cause further damage to the gut flora and are associated with high rates of recurrent disease. Reducing disease recurrence is the key clinical issue in CDI as repeat episodes are typically more severe and associated with an increase in mortality rates and healthcare costs. The economic impact of CDI is significant with one study estimating annual acute care costs at $4.8 billion in the US.

About Ridinilazole
Ridinilazole is a small molecule antibiotic that Summit is developing for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a targeted spectrum of activity that combined a potent bactericidal effect against all clinical isolates of C. difficile tested with minimal impact on other bacteria that are typically found in the gut microbiome. In a Phase 2 proof of concept trial in CDI patients, ridinilazole showed statistical superiority in sustained clinical response ('SCR') rates compared to the standard of care, vancomycin. In that trial, SCR was defined as clinical cure at end of treatment and no recurrence of CDI within 30 days of the end of therapy. Ridinilazole was also shown to be highly preserving of the gut microbiome in the Phase 2 proof of concept trial, which was believed to be the reason for the improved clinical outcome for the ridinilazole-treated patients. In addition, ridinilazole preserved the gut microbiome to a greater extent than the marketed narrow-spectrum antibiotic fidaxomicin in an exploratory Phase 2 clinical trial. Ridinilazole, an orally administered small molecule, has received Qualified Infectious Disease Product ('QIDP') designation and has been granted Fast Track designation by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include a potential extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics
Summit Therapeutics is a leader in antibiotic innovation. Our new mechanism antibiotics are designed to become the new standards of care for the benefit of patients, and create value for payors and healthcare providers. We are currently developing new mechanism antibiotics for C. difficile infection and gonorrhoea and are using our proprietary Discuva Platform to expand our pipeline. For more information, visit www.summitplc.com and follow us on Twitter @summitplc.

[freedosh] 03/10/2018 11:47

Summit would make a brilliant fit for Roche. They already have a rapid test for tracking C Diff strains but their therapeutic efforts have been focused on gram negative drug resistant bacteria. With acquisition of Summit they would gain rapid access to our C Diff and gonorrhea programmes. Substantial potential markets.
Roche also have BARDA support.

[chrisatrdg] 03/10/2018 08:25

Detailed below is more information on the Roche/Discuva deal detailing values of the initial contract:

Roche teams up with UK's Discuva for new antibiotic
2nd March 2014



Edit: Second article



Edit: Third article

[chrisatrdg] 26/9/2018 12:02

RNS Out today

Summit Therapeutics plc - SUMM
Summit to Highlight Potential of Precision Antibiotic Ridinilazole to Treat C. difficile Infection and Reduce Recurrent Disease at ID Week 2018
Released 12:00 26-Sep-2018


Summit Therapeutics plc
(‘Summit’ or the ’Company’)

Summit to Highlight Potential of Precision Antibiotic Ridinilazole to Treat C. difficile Infection and Reduce Recurrent Disease at ID Week 2018

Oxford, UK, and Cambridge, MA, US, 26 September 2018 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), a leader in new mechanism antibiotic innovation, announces that it will present data on its Phase 3-ready precision antibiotic ridinilazole for the treatment of C. difficile infection at ID Week, 3-7 October 2018 in San Francisco, CA.

Details of the presentations are below.

Oral Presentation

Title: Ridinilazole (RDZ) for Clostridium difficile infection (CDI): Correlation of In Vitro Spectrum of Activity with Human Gut Microbiome Profiles from a Phase 2 Clinical Trial
Session: Oral Abstract Session: Translating Microbiome Science into Practice
Date: 6 October 2018, 11:15AM PDT
Location: W 2002
Authors: Richard Vickers, Ellie J C Goldstein, Diane Citron, David Snydman, Cheleste M. Thorpe and Anne V. Kane

Poster Presentations

Title: Combined Analysis of the In Vitro Activity of Ridinilazole (RDZ) Against More Than 500 Clostridium difficile (CD) Clinical Isolates and Impact of RDZ on Cell Morphology
Session: Poster Abstract Session: Novel Agents
Date: 5 October 2018
Location: S Poster Hall
Authors: Esther Duperchy, Eugénie Bassères, Kevin Garey, and Richard Vickers

Title: Pharmacokinetics and Safety of Ridinilazole (RDZ), a Potential New Therapy for Clostridium difficile Infection (CDI): from Animal Models to Patients
Session: Poster Abstract Session: Novel Agents
Date: 5 October 2018
Location: S Poster Hall
Authors: Esther Duperchy, Sumita Chowdhury, Richard Vickers, and Neil Robinson

Title: Ridinilazole (RDZ) for Clostridium difficile Infection (CDI): Impact of Diagnostic Method on Outcomes from a Phase 2 Clinical Trial
Session: Poster Abstract Session: Novel Agents
Date: 5 October 2018
Location: S Poster Hall
Authors: Richard Vickers, Sumita Chowdhury, and Mark Wilcox

Title: Selecting Clostridium difficile Infection (CDI) Outcome Measures Relevant to Public Health Concerns: Experience From a Ridinilazole (RDZ) Phase 2 Trial
Session: Poster Abstract Session: Treatment of AMR Infections
Date: 6 October 2018
Location: S Poster Hall
Authors: Richard Vickers and Sumita Chowdhury

Copies of the presentations will be made available on the Company’s website, www.summitplc.com, at the start of each session.

About Summit Therapeutics
Summit Therapeutics is a leader in antibiotic innovation. Our new mechanism antibiotics are designed to become the new standards of care for the benefit of patients, and create value for payors and healthcare providers. We are currently developing new mechanism antibiotics for C. difficile infection and gonorrhoea and are using our proprietary Discuva Platform to expand our pipeline. For more information, visit www.summitplc.com and follow us on Twitter @summitplc.





Link:

[chrisatrdg] 20/9/2018 19:33

Summit Therapeutics (SMMT) CEO Glyn Edwards on Q2 2018 Results - Earnings Call Transcript

[chrisatrdg] 20/9/2018 19:14

Makes for a good summary of todays event & shows how others see us:

Ridinilazole leading the way as Summit Therapeutics pivots to antibiotics




YY proactive yyy investors

[nobbygnome] 20/9/2018 15:28

LOL I am praying that you will get one right eventually! Of course you did hold SUMM through the recent precipitate decline but at least the company is doing all the right things now unlike IMM!

I have high hopes here now....

[waterloo01] 20/9/2018 14:53

Probably right but at least they have a 50% upside stake. More to the point they had £17m in bank end July with a further £10m-£13m due via R&D tax refund and already committed R&D funding.

Get a sense they will also sell off right ex USA which could potentially fund the gap in the RDZ trials.

Nobbygnome, I've told you before, please do avoid anything I'm in. Do us all a favour!

[chrisatrdg] 20/9/2018 14:48

Hi waterloo01 - I agree with you made public at the time of the take over.I however do not expect any more funds from Roche in the near future.

[chrisatrdg] 20/9/2018 14:41

Nobbygnome - waterloo01 is just stating it as it is i.e. not to expect great sums coming from the Roche deal in the future the primary benefits have already been received based on my earlier views of Discuva but I could be wrong.

[nobbygnome] 20/9/2018 14:34

It is a real shame waterloo is involved here because he is the kiss of death😜. Every share he has undergoes a precipitate fall, RENE being the latest one.....

[waterloo01] 20/9/2018 14:29

No timetable re Roche (they have zero input/control). Will get 50% of any milestones etc (other 50% goes to Discuva ex owners). Edit: Chris above was mentioned publicly at the time.

[chrisatrdg] 20/9/2018 14:28

The details of the Roche deal was on the previous Discuva website which was taken down on take over by Summit however from memory when looking at the details before Discuva was taken over monies were received (substantial sum) as for future milestones details do not exist in the public domain as far as I can see other than the details given when the Discuva take over was announced.

Edit: Discuva's previous Annual Report & Accounts will show incomes received.

[multiplural] 20/9/2018 14:13

Does anyone here have any idea how much, and when, can be expected from the Roche collaboration?

[chrisatrdg] 20/9/2018 14:05

I believe once Summit can demonstrate at their 3rd Qtr's results (31.10.18) that they have a cash runway beyond 30.09.19 we will be able to judge when the next fund raise will be or not.

[nobbygnome] 20/9/2018 14:00

Presentations were a bit stilted but interesting nevertheless. The most relevant part for me was the Eskape program because it greatly reduces the risk. However, I don’t agree that they shouldn’t try to license the ones they don’t select. It would be good to get some upfront funding from 3rd parties for some of those and could build shareholder value in the short term albeit to a reduced degree than the selected ones.

Overall as with so any Aim companies SUMM is clearly undervalued!

[chrisatrdg] 20/9/2018 13:59

NASDAQ Pre-market looking good now at $2.45 = £0.37p hopefully AIM to follow after conclusion of phone conference.

[waterloo01] 20/9/2018 13:50

Ongoing discussions re non US territory for RDZ (aka S America deal). New drugs largely funded via grants etc rather than the company.

[waterloo01] 20/9/2018 13:04

Further $10m-$13m revenue expected in 3rd Q. So even better!

Actually £10m - £13m.

[waterloo01] 20/9/2018 12:38

Kirk, not a cash item though, just accounting. Football yes basically. Will still need funds for phase 3 but the gap could be filled by "Management expects to finance its cash needs through a combination of some, or all, of the following: equity offerings, collaborations, strategic alliances, grants and clinical trial support from government entities, philanthropic, non-government and not for profit organisations and patient advocacy groups, debt financings, and marketing, distribution or licensing arrangements."

[football] 20/9/2018 12:35

So basically the share price covers money in the bank and the funding we have already lined up and all the drugs we have in the pipeline for free going by market?

[kirk 6] 20/9/2018 12:31

Nice -- Profit for the three months ended 31 July 2018 of GBP26.6 million compared to a loss of GBP3.3 million for the three months ended 31 July 2017. Profit in the current quarter was driven by the recognition of all deferred revenue related to the Sarepta licence and collaboration agreement following the discontinuation of ezutromid development

[waterloo01] 20/9/2018 12:03

Reads well. £17m cash still left and fully funded through end 2019. Finally rid of Barry and Stephen.