Unprecedented Clinical Data Could Capture $3B Uncontested Market
- US-FDA IND Filed Mar. 2nd, 2018 – first-in-class drug prevents post-surgical adhesions
- Groundbreaking Mechanistic Data Presented at Society of Reproductive Investigations (SRI), San Diego, Mar. 9th, 2018
- Series B Financing $25M (Led by Dominick & Dickerman LLC, NYC)
GELEEN, Netherlands, March 13, 2018 /PRNewswire/ - Not since 1867 when British surgeon Dr. Joseph Lister used carbolic acid to cut mortality rates due to infection from 80% to 5% has there been a product that promises to make a similar impact. Evitar™ means "to prevent or eradicate" in Spanish; unprecedented clinical data (over 80% efficacy for the complete prevention of post operative fibrosis or adhesions), sets a new benchmark to fully capture a $3 BN uncontested market. With almost 51 abdominal surgeries done every minute in the US, the impact and opportunity is clear. Novel approach renders less effective solutions obsolete and irrelevant.
"Evitar™ offers a potential therapeutic option for preventing adhesion formation based on sound scientific principles with the exciting triad of Efficacy, Safety and Ease of Use."
James Greenberg, MD. FACOG
Post operative fibrosis occurs in almost 93% of surgeries and remains the single largest complication of surgery. Evitar™ is quickly and easily administered into the peritoneal cavity via laparoscope or in open surgeries just after irrigation and prior to closure. A double-blind placebo controlled randomized study showed statistically significant complete prevention of post surgical fibrosis in over 83-89% of patients. The study, conducted by Temple deployed independent and blinded medical reviewers from prestigious universities in Montreal and Boston. "We wanted to remove as many of the biases as possible," says Temple's Chief Science Officer, Dr. Lynne Robertson. Safety data from the trial was equally impressive. Results are part of an abstract submission for the upcoming AAGL (www.aagl.org) meeting in Las Vegas.
"There is a large unmet need for prevention of adhesions. The risks of adhesions include a lifelong risk (re-admissions, re-operations, & significant reduced quality of life) for various clinical entities. The mechanism behind previous agents for prevention of adhesions was based solely on separation of injured peritoneal surfaces. Evitar™ provides a totally new pre-emptive concept, that actively intervenes in the molecular pathway of adhesion formation."
Richard ten Broek, MD, PhD.
Nijmegen, The Netherlands
Ground breaking data to support Evitar's mechanism of action was developed by Dr. Robertson, in collaboration with the leading adhesion research laboratory of Dr. Ghassan Saed of Wayne State University. Dr. Saed presented the study results at the March 9th SRI conference in San Diego. Robertson's hypothesis that Evitar's MoA involves regulation of key mediators of the inflammatory response to injury was supported by the study's findings. "Evitar™ is a sentinel moment in surgery and the impact is immense."
Temple is a privately held clinical stage development company focused on improving clinical outcomes by developing patented drugs for proven and reimbursable high unmet medical needs in hospitals.
SOURCE Temple Therapeutics BV