TTX 333   Prevention of Post Surgical Tissue Fibrosis and Adhesions

Novel Surgiceutical approach prevents post-operative tissue fibrosis following abdominal and pelvic surgeries
 

Market

Evitar™ A New Paradigm-90% of Market is Untapped and Uncontested 

  • Surgiceutical approach is easy to use, novel mechanism proves effective, requires no training or capital investment, is not site specific, quick to administer under 1 minute
  • Significant market development completed and medical need established by Sanofi-Genzyme,  Baxter, Johnson and Johnson over last 15-30 years with global sales of $600M (est)
  • Baxter acquires Seprafilm from Sanofi for $350M in November of 2019 (closed Feb 2020). Seprafilm represents 3% of the market potential with significant room for growth

Milestones

  • Q3'16 - FDA pre-IND meeting completed
  • Q4'17 - ICH-GCP Compliant double blind placebo controlled randomized study completed
  • Q1'18 - Temple announces on March 13, 2018 Unrivaled Clinical Efficacy
  • Q1'18 - Temple presents groundbreaking mechanistic data March 9, 2018 at SRI in San Diego
  • Q2'18 - Mechanistic data accepted for publicaiton in top ranked & highly cited Ob/Gyn Journal
  • Q4'18 - Clinical Data and Mechanistic Data accepted for presentation at AAGL in November of 2018 in Las Vegas
  • Q3'19 - Temple is awarded a patent from USPTO which extends Evitar's use to all surgeries and extends patent life out to 2038
  • Q3'19 - Temple works with regulatory authorities and crafts development plan to market registration for first drug candidate for adhesion prevention
  • Q4'19 - Temple embarks on capital raise to bring lead programs to market registration
  • Q4'19 - Temple and its researchers prove Evitar's efficacy in another indication; new patents and publication soon to follow
  • Q1'20-Q4'20 - Temple is completing financing and filing for regulatory approval to begin next phase of clinical studies

Technology

Current literature suggests that addressing hypoxia and shifting anaerobic metabolism to aerobic metabolism could be a viable strategy to preventing post surgery tissue fibrosis (adhesions). (ASRM) (Awonuga AO) (Diamond MP) (Duron) (Valerie I. Shavell) Evitar™ is a proprietary aqueous formulation of naturally occurring amino acids-a SURGICEUTICAL.  In a randomized double blind randomized controlled study (NCT04250467) in laparoscopic myomectomies which included 'all-comer' patients, 93.3% of Evitar™ treated patients did not have any evidence of tissue fibrosis at any of the 23 anatomical sites within the abdominal cavity (p=.0411) at second look laparoscopy (SLL), as compared to 58.8% in the control. This despite 80% of patients in the Evitar™ arm had complex presentations known to be associated with high risk of fibrosis formation as compared to 40% of patients in the control arm. The study was powered to 90%, alpha .05 to detect a 70% difference. The clinical results were presented at the 2018 AAGL World Congress. Further, the mechanistic abstract  (Robertson et. al 2019) was also selected for presentation at the same conference.  The clinical manuscript has been submitted for publication.

Market: limited options - first Surgiceutical to successfully translate in-vitro work to a treatment for patients, expands usage

Post operative tissue fibrosis/scar tissue or adhesions are a major medical problem with no current viable solution for laparoscopic surgeries.  For surgeons, bands of scar tissue complicate entry in robotic or laparoscopic surgeries, complicate surgical planes and take significant time (up to 4 hours) to cut and take down (adhesiolysis) before completing the scheduled surgical procedure. It has been shown that 1 in 5 patients (20%) undergoing adhesiolysis suffer an accidental bowel injury.  For hospitals, extended OR time also reduces efficiency, decreases revenues and explains why in part, surgically induced tissue fibrosis or adhesions are the single largest cause of surgical compliations, and reduced operating margins (JAMA 2016). Tissue fibrosis complications also leads to reduced clinical outcomes, high hospital readmission rates, reduced quality of life for patients and medical lawsuits. It can lead to serious and societal expensive complications such infertility, intestinal obstruction and pelvic pain.

Reversing Hypoxia and Restoring Homeostasis May Prevent Adhesions

(Valerie I. Shavell)

Evitar™ addresses this unmet medical need by preventing tissue fibrosis as a result of abdominal and pelvic surgeries. It is easy to use in laparoscopic procedures. It is the First in Class surgiceutical approach that has shown in a double blinded randomized controlled study to safely and effectively prevent the absence of any scar tissue in over 90% of patients. This type of scarring occurs in after most surgical procedures and is a worldwide major concern for surgeons, patients and the health care system. (Menzies) (Koji Okabayashi) (Trew)

EASY TO USE, QUICK TO APPLY & NO ADVERSE EVENTS REPORTED  IN CURRENT TRIAL

Medical devices based on untargeted mechanisms of action (e.g. “barrier”-type, colloid osmotic agent) currently serve the market for open surgery. However, market leaders Seprafilm® (Baxter) and Interceed® (Ethicon) are not adapted for or approved by the FDA for laparoscopic surgery, are known to extend mean operation time and difficult to handle. (Trew)

Burden Still an Unmet Medical Need

Works Cited

ASRM. "Pathogenesis, Consequences, and Control of Peritoneal Adhesions in Gynecologic Surgery." Fertility and Sterilty 99.6 (2013).

Awonuga AO, Fletcher NM, Saed GM, Diamond MP. "Postoperative adhesion development following cesarean and open intra-abdominal gynecological operations: a review." Reproductive Sciences 18.12 (2011): 1166-1185.

Diamond MP, Freeman ML. "Clinical implications of postsurgical adhesions 2001." Hum Reprod Update 7 (2001): 567-576.

Duron, Jean-Jacques. "Postoperative intraperitoneal adhesion pathophysiology." The Association of Coloproctology of Great Britain and Ireland 9 (2007): 14-24.

John R Lue, Louise S Boyd and Michael P Diamond. "Pelvic Adhesive Disease: Current Approaches to Management." Journal of Women's Health,Issues and Care 3.3 (2014).

Koji Okabayashi, Hutan Ashrafian, Emmanouil Zacharakis, Hirotoshi Hasegawa, Yuko Kitagawa, Thanos Athanasiou, Ara Darzi. "Adhesions after abdominal surgery: a systematic review of the incidence, distribution and severity." Surgery Today (2013).

Menzies, D. "Peritoneal adhesions. Incidence, cause, and prevention." Surgery Annals 24(Pt1) (1992): 27-45.

Trew, Geoffrey. "Consensus in adhesion reduction management-Supplement." The Obstetrician and Gynecologist 6.2 (2004).

Valerie I. Shavell, Ghassan M. Saed, and Michael Diamond. "Cellular Metabolism:Contribution to Postoperative Adhesion Development." Reproductive Sciences 16 (2009): 627-634.

Vero´nica Go´mez-Gil, Gemma Pascual, Ba´rbara Pe´rez-Ko¨hler, Alberto Cifuentes, Julia Buja´n and Juan M. Bello´n. "Involvement of transforming growth factor-b3 and betaglycan in the cytoarchitecture of postoperative omental adhesions." Journal of Surgical Research 187 (2014): 699-711.

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