SMMT Summit Therapeutics Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

OF THE SECURITIES EXCHANGE ACT OF 1934

For the month of January 2016

Commission File Number 001-36866

 

 

SUMMIT THERAPEUTICS PLC

(Translation of registrant’s name into English)

 

 

85b Park Drive

Milton Park, Abingdon

Oxfordshire OX14 4RY

United Kingdom

(Address of principal executive office)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:

FORM 20-F  x            FORM 40-F  ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ¨

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ¨

Indicate by check mark whether the registrant by furnishing the information contained in this form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934:

YES  ¨            NO   x

If “Yes” is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b):

 

 

 

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On January 19, 2016, Summit Therapeutics plc (the “Company”) issued a press release announcing that the European Patent Office has granted the Company a key patent covering the novel antibiotic, ridinilazole, for the treatment of the infectious disease Clostridium difficile infection. The related press release is attached hereto as Exhibit 99.1.

On January 21, 2016, the Company issued a press release announcing that it has received approval from the UK Medicines and Healthcare products Regulatory Agency and the Research Ethics Committee to initiate PhaseOut DMD, a Phase 2 proof of concept clinical trial of SMT C1100 in patients with Duchenne muscular dystrophy. The related press release is attached hereto as Exhibit 99.2.

The information contained in Exhibits 99.1 and 99.2 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Date: January 22, 2016

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EXHIBIT INDEX

 

Exhibit Number		Description
99.1		Press Release dated January 19, 2016
99.2		Press Release dated January 21, 2016

Exhibit 99.1

 

Summit Therapeutics plc

(“Summit” or “the Company”)

SUMMIT THERAPEUTICS GRANTED KEY EUROPEAN PATENT FOR NOVEL ANTIBIOTIC RIDINILAZOLE FOR TREATMENT OF C. DIFFICILE INFECTION

Oxford, UK, 19 January 2016 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy and Clostridium difficile infection (‘CDI’), announces that the European Patent Office (‘EPO’) has granted a key patent covering the novel antibiotic, ridinilazole, and that the opposition period has expired with the patent having faced no challenge. The patent covers the use of ridinilazole for the treatment of infections caused by the bacterium Clostridium difficile.

“This is a key patent protecting the use of ridinilazole for the treatment of CDI and its grant and emergence from the period of opposition means this patent is now effective in Europe, in addition to the other major commercial markets including the United States and Japan,” commented Glyn Edwards, Chief Executive Officer of Summit. “The robust patent portfolio for ridinilazole, together with the strong Phase 2 clinical data showing statistical superiority over vancomycin, the current standard of care, further strengthens the potential commercial value of this novel product candidate in the treatment of CDI.”

The patent (European patent number EP2373631) is entitled “Antibacterial Compounds” and will provide a period of exclusivity for the use of ridinilazole in the treatment of CDI through until 1^st December 2029, with the possibility of patent term extension through to 1^st June 2035 subject to the obtaining of Supplementary Protection Certificates and a paediatric investigation plan on marketing approval. The patent has also been validated in all available contracting countries to the European Patent Convention, and so is now in force in over 30 European states including the United Kingdom, Germany, France, Spain, Italy, Switzerland and Norway. Patent protection has previously been granted for ridinilazole for the treatment of CDI in other countries including the United States, Australia, New Zealand, Japan, Russia and China, in addition to other territories.

Ridinilazole is a novel class small molecule antibiotic that Summit is developing for the treatment of CDI. Top-line results from a Phase 2 proof of concept trial reported in late 2015 showed that ridinilazole was statistically superior to vancomycin, the current standard of care, in the endpoint of sustained clinical response (‘SCR’). SCR was measured as cure at the end of treatment and no recurrence of CDI within 30 days of the end of treatment.

About C. difficile Infection

C. difficile infection is a serious healthcare threat in hospitals, long-term care homes and increasingly the wider community with between 450,000 and 700,000 cases of CDI in the US annually. It is caused by an infection of the colon by the bacterium C. difficile, which produces toxins that cause inflammation, 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, and these cause further damage to the gut flora and are associated with high rates of recurrent disease. Recurrent disease is the key clinical issue 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.

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About Ridinilazole

Ridinilazole (SMT19969) is an orally administered small molecule antibiotic that Summit is developing specifically for the treatment of CDI. In preclinical efficacy studies, ridinilazole exhibited a narrow spectrum of activity and had a potent bactericidal effect against all clinical isolates of C. difficile tested. 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 this 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 has received Qualified Infectious Disease Product (‘QIDP’) designation and has been granted Fast Track status by the US Food and Drug Administration. The QIDP incentives are provided through the US GAIN Act and include an extension of marketing exclusivity for an additional five years upon FDA approval.

About Summit Therapeutics

Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

For more information, please contact:

 

Summit Glyn Edwards / Richard Pye (UK office) Erik Ostrowski / Michelle Avery (US office)		Tel: +44 (0)1235 443 951 +1 617 225 4455
Cairn Financial Advisers LLP (Nominated Adviser) Liam Murray / Tony Rawlinson		Tel: +44 (0)20 77148 7900
N+1 Singer (Broker) Aubrey Powell / Jen Boorer		Tel: +44 (0)20 7496 3000
Peckwater PR (Financial public relations, UK) Tarquin Edwards		Tel: +44 (0)7879 458 364 tarquin.edwards@peckwaterpr.co.uk
MacDougall Biomedical Communications (US media contact) Chris Erdman		Tel: +1 781 235 3060 cerdman@macbiocom.com

Forward-looking Statements

Any statements in this press release about Summit’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of Summit’s product candidates, the therapeutic potential of Summit’s product candidates, and the timing of initiation, completion and availability of data from clinical trials, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important

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factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from on-going and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Summit’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that Summit makes with the Securities and Exchange Commission including Summit’s Annual Report on Form 20-F for the fiscal year ended January 31, 2015. Accordingly readers should not place undue reliance on forward looking statements or information. In addition, any forward looking statements included in this press release represent Summit’s views only as of the date of this release and should not be relied upon as representing Summit’s views as of any subsequent date. Summit specifically disclaims any obligation to update any forward-looking statements included in this press release.

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Exhibit 99.2

 

Summit Therapeutics plc

(“Summit” or “the Company”)

SUMMIT THERAPEUTICS RECEIVES REGULATORY APPROVAL TO INITIATE PhaseOut DMD, A PHASE 2 CLINICAL TRIAL OF SMT C1100 IN PATIENTS WITH DMD

Oxford, UK, 21 January 2016 – Summit Therapeutics plc (NASDAQ: SMMT, AIM: SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection, announces that it has received approval from the UK Medicines and Healthcare products Regulatory Agency and the Research Ethics Committee to initiate PhaseOut DMD, a Phase 2 proof of concept clinical trial of SMT C1100 in patients with DMD. SMT C1100 is an orally administered, small molecule utrophin modulator that the Company believes has the potential to treat all boys and young men with DMD, regardless of their underlying dystrophin gene mutation. Utrophin is functionally and structurally similar to dystrophin, a protein which is essential for the healthy function of muscles.

“Our lead utrophin modulator, SMT C1100, has demonstrated disease-modifying potential in preclinical studies to date, and with the initiation of PhaseOut DMD, we are at a stage in SMT C1100’s clinical development where we are evaluating the possibility of this benefit in patients,” said Ralf Rosskamp, MD, Chief Medical Officer of Summit. “We look forward to opening clinical trial sites in the UK and enrolling the first patients soon.”

PhaseOut DMD aims to provide proof of concept for SMT C1100 and utrophin modulation through measurements of muscle fat infiltration, as well as measuring utrophin protein and muscle fibre regeneration in muscle biopsies. The 48-week open-label trial is expected to enrol up to 40 boys ranging in age from their fifth to their tenth birthdays at sites in Europe and the US (subject to the US Food and Drug Administration, or FDA, regulatory approval). The primary endpoint of the trial is the change from baseline in magnetic resonance imaging parameters related to fat infiltration and inflammation of the leg muscles. Functional endpoints, including the six-minute walk test, North Star Ambulatory Assessment and patient reported outcomes, are also being explored. Summit expects to report data from the first group of patients enrolled in the trial periodically from the second half of 2016 onwards with the first set of 24-week muscle biopsy data expected to be available before the end of 2016.

The Company expects to submit an investigational new drug application to the FDA to allow PhaseOut DMD to also enrol patients in the US. In addition, the Company is exploring means by which to enrol patients who have participated in previous clinical trials of SMT C1100, but who may not meet the inclusion and exclusion criteria for PhaseOut DMD. Summit expects that further information about PhaseOut DMD will shortly be available on www.clinicaltrials.gov.

About Utrophin Modulation in DMD

DMD is a progressive muscle wasting disease that affects around 50,000 boys and young men in the developed world. The disease is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles. There is currently no cure for DMD and life expectancy is into the late twenties. Utrophin protein is functionally and structurally similar to dystrophin. In preclinical studies, the continued expression of utrophin has a meaningful, positive effect on muscle performance. Summit believes that utrophin modulation has the potential to slow down or even stop the progression of DMD, regardless of the underlying dystrophin gene mutation. Summit also believes that

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utrophin modulation could potentially be complementary to other therapeutic approaches for DMD. The Company’s lead utrophin modulator is an orally administered, small molecule called SMT C1100. DMD is an orphan disease, and the US Food and Drug Administration and the European Medicines Agency have granted orphan drug status to SMT C1100. Orphan drugs receive a number of benefits including additional regulatory support and a period of market exclusivity following approval.

About Summit Therapeutics

Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

For more information, please contact:

 

Summit Glyn Edwards / Richard Pye (UK office) Erik Ostrowski / Michelle Avery (US office)		Tel: +44 (0)1235 443 951 +1 617 225 4455
Cairn Financial Advisers LLP (Nominated Adviser) Liam Murray / Tony Rawlinson		Tel: +44 (0)20 77148 7900
N+1 Singer (Broker) Aubrey Powell / Jen Boorer		Tel: +44 (0)20 7496 3000
Peckwater PR (Financial public relations, UK) Tarquin Edwards		Tel: +44 (0)7879 458 364 tarquin.edwards@peckwaterpr.co.uk
MacDougall Biomedical Communications (US media contact) Chris Erdman		Tel: +1 781 235 3060 cerdman@macbiocom.com

Forward-looking Statements

Any statements in this press release about Summit’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of Summit’s product candidates, the therapeutic potential of Summit’s product candidates, and the timing of initiation, completion and availability of data from clinical trials, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from on-going and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Summit’s foreseeable and unforeseeable operating

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expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that Summit makes with the Securities and Exchange Commission including Summit’s Annual Report on Form 20-F for the fiscal year ended January 31, 2015. Accordingly readers should not place undue reliance on forward looking statements or information. In addition, any forward looking statements included in this press release represent Summit’s views only as of the date of this release and should not be relied upon as representing Summit’s views as of any subsequent date. Summit specifically disclaims any obligation to update any forward-looking statements included in this press release.

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