Clinical Trials

PROMOTE

PROMOTE is inspired by PRM-151’s potential ability to PROMOTE:
  • Prevention of new fibrosis
  • Reduction of established fibrosis
  • Improved organ function
Promedior is currently conducting two Phase 2 clinical trials to demonstrate the ability of its product candidate, PRM-151, to address the unmet needs of patients in Myelofibrosis (MF) and Idiopathic Pulmonary Fibrosis (IPF). PRM-151 is formulated for intravenous injection.

Myelofibrosis (MF)
The Phase 2 clinical trial to evaluate PRM-151 in MF is a multi-center, randomized, double-blind, two stage, adaptive design study to determine efficacy and safety of PRM-151 in patients with Primary Myelofibrosis (PMF), Post-Polycythemia Vera MF (post-PV MF), or Post-Essential Thrombocythemia MF (post-ET MF). Patients will be randomized to one of three doses: 0.3 mg/kg, 3.0 mg/kg or 10 mg/kg of PRM-151. The primary objective is to determine the effect size of three different doses of PRM-151 on reduction in bone marrow fibrosis by ≥1 grade in intermediate-1, intermediate—2, and high risk patients with PMF, post PV-MF, or post ET-MF who are anemic or thrombocytopenic and who are ineligible for, intolerant of, or have had an inadequate response to ruxolitinib.

Idiopathic Pulmonary Fibrosis (IPF)
The Phase 2 clinical trial to evaluate PRM-151 in IPF is a randomized, double-blind, placebo-controlled, pilot study designed to determine efficacy and safety of PRM-151 in patients with Idiopathic Pulmonary Fibrosis (IPF). Patients meeting the eligibility criteria for the study will be randomized to PRM-151 10 mg/kg every 4 weeks or placebo. Efficacy will be evaluated through pulmonary function tests (PFTs), high resolution CT (HRCT), 6-minute walk test (6MWT), and Patient Reported Outcomes (PROs). The primary objective is to determine the effect size of PRM-151 relative to placebo in change from Baseline to Week 28 in mean FVC% predicted, pooling patients on a stable dose of pirfenidone or nintedanib and patients not on other treatment for IPF.

Promedior Expanded Access Policy
Promedior, Inc. (Promedior) is committed to developing our investigational therapies as safe and effective medicines for patients as quickly as possible. Expanded access (also called compassionate use) refers to the use of an investigational new drug to treat a patient outside of a clinical trial. A number of factors consistent with the U.S. Food and Drug Administration’s (FDA’s) and other regulatory bodies’ guidelines should be taken into account when considering expanded access, including whether:
  • The patient has a serious or life-threatening disease or condition and has exhausted all available therapies;
  • There are ongoing clinical trials of the investigational therapy or similar investigational therapies or planned clinical trials starting reasonably soon in which the patient is eligible, or the patient is otherwise unable to participate in one of these trials;
  • There is sufficient evidence of a potential benefit from the use of the investigational therapy and outweighs the potential risks, and those risk are not unreasonable in the context of the disease or condition being treated;
  • Providing expanded access will not interfere with clinical trials or other development efforts that could support the approval of the investigational therapy by a health authority, such as the FDA; and
  • A sufficient supply of the investigational therapy is anticipated and may reasonably accommodate the likely duration of treatment for the patient, taking into account the needs of clinical trials and other patients in treatment.
At this time, Promedior believes that participating in its planned clinical trials is the best way to access our medicines that are not yet approved by the FDA and is unable to provide our investigational medicines via expanded access. We have considered many factors, including our ability to maintain supply for our planned clinical trials, enroll and complete our upcoming clinical trials, and make reasonable assessments of potential risk versus benefit for patients outside the clinical trial setting. In the event that Promedior decides to consider expanded access use for its investigational therapies in the future, we will evaluate and respond to each expanded access request on a case-by-case basis using criteria that ensures such requests are considered in a fair and consistent manner.

If you or a family member are/is interested in gaining access to one of our investigational therapies, we encourage you to consult with your physician regarding the possibility of participating in our planned clinical trials.

If you have additional questions, please speak with your physician or contact us via email at info@promedior.com. We anticipate acknowledging receipt of such inquiries sent to this email within 5 business days.

The posting of this policy by Promedior shall not serve as a guarantee of access to any specific investigational therapy by any individual patient. In accordance with the 21st Century Cures Act, Promedior may revise this expanded access policy at any time. The policy will be updated with a hyperlink or other reference to the expanded access record on clinicaltrials.gov after such record becomes active. At this time, Promedior also is not making right to try access available for our investigational medicines, in order to focus our resources on executing our planned clinical trials.