Monday, September 26, 2016 9:14:41 AM
Source: GlobeNewswire Inc.
Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection, today announces it has received Fast Track designation from the US Food and Drug Administration (‘FDA’) for ezutromid in the treatment of DMD. Ezutromid is a utrophin modulator and represents a potential disease modifying treatment for all patients with the fatal muscle wasting disease DMD.
“Fast Track designation underscores the importance that the FDA places on developing new treatments for life-threatening disorders, such as DMD, and aligns well with our recently outlined strategy to accelerate the development of ezutromid to market,” said Glyn Edwards, Chief Executive Officer of Summit. “As a utrophin modulator, ezutromid has the potential to significantly advance the state of care for all patients with DMD, regardless of their underlying genetic fault. We look forward to ezutromid’s continued progress in our ongoing Phase 2 clinical trial, PhaseOut DMD.”
Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions that address an unmet medical need. Advantages of Fast Track designation include opportunities for more frequent interactions with the FDA during all aspects of development, submission of a New Drug Application (‘NDA’) on a rolling basis, and eligibility for accelerated approval and priority review. This designation is in addition to ezutromid being granted Orphan Drug designation by the FDA and the European Medicines Agency.
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 utrophin modulation could potentially be complementary to other therapeutic approaches for DMD. The Company’s lead utrophin modulator, ezutromid, is an orally administered, small molecule. DMD is an orphan disease, and the US Food and Drug Administration and the European Medicines Agency have granted Orphan Drug designation to ezutromid. Orphan drugs receive a number of benefits including additional regulatory support and a period of market exclusivity following approval. In addition, ezutromid has been granted Fast Track designation by the FDA.
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).
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 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, 2016. 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.
Recent SMMT News
- Form S-3ASR - Automatic shelf registration statement of securities of well-known seasoned issuers • Edgar (US Regulatory) • 09/19/2024 09:28:00 PM
- Promising Anti-Tumor Activity and Safety of Ivonescimab in Combination Therapies in CRC, TNBC, and HNSCC Featured at ESMO 2024 • Business Wire • 09/16/2024 10:30:00 AM
- Form 4 - Statement of changes in beneficial ownership of securities • Edgar (US Regulatory) • 09/13/2024 09:26:07 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/12/2024 10:49:52 AM
- Summit Therapeutics Raises $235 Million • Business Wire • 09/12/2024 10:30:00 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 09/09/2024 11:23:04 AM
- Ivonescimab Monotherapy Reduced the Risk of Disease Progression or Death by 49% Compared to Pembrolizumab Monotherapy in First-Line Treatment of Patients with PD-L1 Positive Advanced NSCLC in China • Business Wire • 09/08/2024 03:45:00 PM
- Summit Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 09/06/2024 08:15:00 PM
- HARMONi-2, Featuring Ivonescimab Monotherapy vs. Pembrolizumab Monotherapy, to be Showcased in Presidential Symposium at WCLC 2024 • Business Wire • 08/12/2024 11:00:00 AM
- Two Ivonescimab (PD-1/VEGF) Results including Phase 3 Monotherapy versus Pembrolizumab Monotherapy in First-Line Treatment for PD-L1 Positive NSCLC to Be Presented at WCLC 2024 • PR Newswire (US) • 08/11/2024 11:30:00 PM
- Summit Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 08/09/2024 08:15:00 PM
- Form S-3ASR - Automatic shelf registration statement of securities of well-known seasoned issuers • Edgar (US Regulatory) • 08/06/2024 01:03:29 PM
- Form 10-Q - Quarterly report [Sections 13 or 15(d)] • Edgar (US Regulatory) • 08/06/2024 11:37:21 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 08/06/2024 11:14:08 AM
- Summit Therapeutics Reports Financial Results and Operational Progress for the Second Quarter and Six Months Ended June 30, 2024 • Business Wire • 08/06/2024 11:00:00 AM
- Summit Therapeutics to Host Second Quarter 2024 Financial Results & Operational Progress Call on August 6, 2024 • Business Wire • 07/29/2024 08:15:00 PM
- Summit Therapeutics and MD Anderson Announce Strategic Collaboration to Accelerate Development of Ivonescimab • Business Wire • 07/25/2024 12:00:00 PM
- Summit Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) • Business Wire • 07/03/2024 08:15:00 PM
- Summit Therapeutics Appoints Jeff Huber, Transformational Google and GRAIL Executive, to its Board of Directors • Business Wire • 06/27/2024 08:15:00 PM
- Form D - Notice of Exempt Offering of Securities • Edgar (US Regulatory) • 06/18/2024 09:14:58 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/17/2024 09:25:01 PM
- Form DEFA14A - Additional definitive proxy soliciting materials and Rule 14(a)(12) material • Edgar (US Regulatory) • 06/13/2024 06:03:15 PM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 10:18:31 AM
- Form 8-K - Current report • Edgar (US Regulatory) • 06/03/2024 10:05:37 AM
North Bay Resources Commences Operations at Bishop Gold Mill, Inyo County, California; Engages Sabean Group Management Consulting • NBRI • Sep 25, 2024 9:15 AM
CEO David B. Dorwart Anticipates a Bright Future at Good Gaming Inc. Through His Most Recent Shareholder Update • GMER • Sep 25, 2024 8:30 AM
Cannabix Technologies and Omega Laboratories Inc. Advance Marijuana Breathalyzer Technology - Dr. Bruce Goldberger to Present at Society of Forensic Toxicologists Conference • BLOZF • Sep 24, 2024 8:50 AM
Integrated Ventures, Inc Announces Strategic Partnership For GLP-1 (Semaglutide) Procurement Through MedWell USA, LLC. • INTV • Sep 24, 2024 8:45 AM
Avant Technologies Accelerates Creation of AI-Powered Platform to Revolutionize Patient Care • AVAI • Sep 24, 2024 8:00 AM
VHAI - Vocodia Partners with Leading Political Super PACs to Revolutionize Fundraising Efforts • VHAI • Sep 19, 2024 11:48 AM