Temple Therapeutics .
Expanded Access / Compassionate Use / Right to Try Policy
Investigational Product: TTX-333 (Adhesion Prevention Drug Candidate)
1. Purpose and Guiding Principles
Temple Therapeutics is committed to developing safe and effective therapies that address significant unmet medical needs in women’s health and beyond. TTX-333, our investigational adhesion prevention drug candidate, is currently being evaluated in clinical trials and has not yet been approved by any regulatory authority.
We recognize that patients with serious conditions may seek access to investigational medicines outside of clinical trials. This policy outlines the framework under which Temple Therapeutics may consider providing Expanded Access (Compassionate Use, Early Access, or Right to Try) to TTX-333, in line with the 21st Century Cures Act and applicable global regulations.
2. Eligibility Criteria
Expanded Access to TTX-333 may be considered if the following conditions are met:
- No Approved Alternatives: The patient’s home country has no approved treatment for the condition, or available therapies have been exhausted.
- Trial Unavailability: The patient is not eligible for enrollment in an active clinical trial of TTX-333, or no trial is accessible within reasonable geographic or timing constraints.
- Completed or Closed Trials: Clinical trials have ended and patients are awaiting commercial supply, but still face significant unmet need.
- Risk-Benefit Assessment: The potential benefit to the patient, as assessed by the treating physician and Temple Therapeutics’ medical team, justifies the potential risks.
- Regulatory Compliance: Access can be provided in accordance with applicable laws, including FDA, EMA, and local health authorities.
90%
of pelvic and abdominal surgeries result in fibrosis.
No drug treatments currently exist for fibrosis, and surgeries attempting to reverse its effects worsen the condition about 70 percent of the time.
Currently, the most commonly used method for preventing postoperative adhesion is the use of barrier materials, which are thin films placed strategically around the surgical site to physically block fibrotic tissue from joining tissues or organs. These products are, at best, only about 50 percent effective at preventing the development of adhesion and do not actively promote healthy healing of tissues.
TTX-333 is the first investigational drug to demonstrate, in a Level 1a double blind randomized controlled trial, clinically meaningful prevention of post-operative adhesions with a 93.3% efficacy rate. (6)
- Many first Is it there or not? – The study rigorously assessed adhesion presence or absence across 23 anatomical sites in the abdomen, evaluating both adhesion from first time surgery and from those who had previous surgery and adhesions were cut during the procedure.
- With reformation rates >90%, absence was still achieved, a first
- Adhesions are end result of a biological process: Mechanistically, TTX-333 distinguishes itself from physical anti-adhesion barriers by systemically modulating fibrotic pathways, thereby preventing adhesions throughout the entire peritoneal cavity rather than at a localized surgical site.
- It can be easily used in laparoscopic procedures, which expands the market, given trends towards minimally invasive and robotic procedures
- Ease of use, with no training or capital equipment investment required by the hospital.
3. Application Process
Patients and Physicians
- Requests must be initiated by the patient’s treating physician, not by the patient directly.
- The physician should provide:
- Patient’s diagnosis and treatment history.
- Rationale for Expanded Access request.
- Confirmation of exhaustion of all approved options.
- Informed consent documentation signed by the patient.
Submission
Requests should be submitted to Temple Therapeutics Medical Affairs at:
info@templerx.com
Temple Therapeutics will acknowledge receipt of the request within 5 business days.
4. Company Review and Decision
- Requests will be evaluated by the Temple Therapeutics Expanded Access Committee, which includes representatives from Clinical, Medical, and Regulatory Affairs.
- Factors considered include:
- Clinical evidence supporting the request.
- Drug supply availability.
- Impact on ongoing or planned clinical trials.
- Regulatory requirements in the patient’s country.
- Decisions will be communicated in writing to the requesting physician.
Temple Therapeutics reserves the right to decline requests when:
- Criteria are not met,
- Supply is limited and prioritized for clinical trials, or
- Risks outweigh potential benefits.
5. Responsibilities
Temple Therapeutics
- Provide investigational product supply where feasible.
- Ensure compliance with local regulatory frameworks.
- Maintain oversight of safety reporting.
Treating Physician
- Submit and maintain regulatory approvals (e.g., FDA Expanded Access IND, EMA compassionate use application, or local equivalent).
- Obtain and document informed consent from the patient.
- Monitor and report adverse events promptly.
Regulatory Authorities
- Review and approve Expanded Access applications as required under local laws.
- Provide oversight consistent with applicable national frameworks (e.g., FDA, EMA, MHRA, Health Canada).
6. Transparency
Temple Therapeutics is committed to transparency and will:
- Post this policy publicly on the company’s website.
- Provide updates if policy changes occur.
- Report Expanded Access use outcomes to regulators as required.
7. Policy Limitations
- Expanded Access does not guarantee efficacy or safety.
- Access is not a substitute for participation in clinical trials.
- Provision of TTX-333 through this pathway is subject to supply, regulatory requirements, and Temple Therapeutics’ discretion.
8. Contact Information
For all Expanded Access requests and inquiries:
Temple Therapeutics – Medical Affairs
info@templerx.com
Effective Date: September 18, 2025
Review Date: Annually
Temple Therapeutics remains focused on advancing TTX-333 through rigorous clinical development while working with patients, physicians, and regulators to enable responsible access where appropriate.
Safer treatments now.
Temple believes postoperative tissue fibrosis is a serious quality-of-life issue, and we seek to address this condition using top-notch science.
Tissue fibrosis is a persistent complication for many patients. At Temple, we are investing millions of dollars into developing solutions for fibrosis, bringing us closer than ever to delivering a new breakthrough to patients.
“Tissue fibrosis causes adhesions which are a big problem, and we would use this drug in every procedure.”
Dr. Rudy Leon De Wilde
TTX333 for safer surgeries.
Temple is developing an impactful product that dramatically reduces tissue fibrosis in patients undergoing abdominal and pelvic surgery.
The drug, TTX333, is easily administered during surgery, both open and laparoscopic, allowing it to act immediately to prevent the formation of adhesions and promote healthy tissue regeneration at the surgical site.
The formation of fibrotic tissue following surgery is a result of the physical trauma and low oxygen levels experienced by cells during the procedure. This disrupts the Krebs cycle, a key process in cellular respiration, which can lead to the development of fibrosis.
Working on the cellular level, our investigative therapy will be the first therapeutic targeting tissue fibrosis and will act throughout the abdominal area with twice the efficacy of existing approaches.
- Ahmad G, Kim K, Thompson M, Agarwal P, O’Flynn H, Hindocha A, et al. Barrier agents for adhesion prevention after gynaecological surgery. Cochrane Database Syst Rev. 2020;3:CD000475. Epub 2020/03/22. doi: 10.1002/14651858.CD000475.pub4. PubMed PMID: 32199406; PubMed Central PMCID: PMC7085418.
- De Wilde RL, Devassy R, Broek RPGT, Miller CE, Adlan A, Aquino P, et al. The Future of Adhesion Prophylaxis Trials in Abdominal Surgery: An Expert Global Consensus. J Clin Med. 2022;11(6). Epub 20220308. doi: 10.3390/jcm11061476. PubMed PMID: 35329802; PubMed Central PMCID: PMC8950418.
- Krielen P, Stommel MWJ, Pargmae P, Bouvy ND, Bakkum EA, Ellis H, et al. Adhesion-related readmissions after open and laparoscopic surgery: a retrospective cohort study (SCAR update). Lancet. 2020;395(10217):33-41. doi: 10.1016/S0140-6736(19)32636-4. PubMed PMID: 31908284.
- Ten Broek RP, Issa Y, van Santbrink EJ, Bouvy ND, Kruitwagen RF, Jeekel J, et al. Burden of adhesions in abdominal and pelvic surgery: systematic review and met-analysis. BMJ. 2013;347:f5588. Epub 2013/10/03. PubMed PMID: 24092941; PubMed Central PMCID: PMC3789584.
- Van den Beukel BAW, Stommel MWJ, van Leuven S, Strik C, IJsseldijk MA, Joosten F, et al. A Shared Decision Approach to Chronic Abdominal Pain Based on Cine-MRI: A Prospective Cohort Study. Am J Gastroenterol. 2018;113(8):1229-37. Epub 2018/06/27. doi: 10.1038/s41395-018-0158-9. PubMed PMID: 29946174.
- Chizen DR, Rislund DC, Robertson LM, Lim HJ, Tulandi T, Gargiulo AR, et al. A randomized double-blind controlled proof-of-concept study of alanyl-glutamine for reduction of post-myomectomy adhesions. Eur J Obstet Gynecol Reprod Biol. 2023;284:180-8. Epub 20230329. doi: 10.1016/j.ejogrb.2023.03.032. PubMed PMID: 37023559.
30%
of patients undergoing abdominal surgery will be readmitted due to an adhesion complication within 10 years.