Upcoming Clinical Trials
Information about our upcoming clinical trial, The ALERT Study, is found on clinicaltrials.gov at this link Safety of Lixivaptan in Subjects PreviouslyTreated with Tolvaptan for Autosomal Dominant Polycystic Kidney Disease.
Completed Clinical Trials
We have completed the ELiSA Study (Evaluation of Lixivaptan In Subjects with ADPKD), a Phase 2 clinical trial that evaluated the safety, pharmacokinetics and pharmacodynamics of multiple doses of lixivaptan in patients with ADPKD with relatively preserved kidney function (chronic kidney disease stages CKD1 and CKD2) and moderately impaired renal function (CKD3).
Preliminary results of the study confirmed that lixivaptan is a potent vasopressin V2 receptor antagonist in patients with CKD. Vasopressin V2 receptor antagonism is the only mechanism of action found to be clinically effective for the treatment of ADPKD.
The study also defined the dose range for the upcoming Phase 3 study in ADPKD.
Lixivaptan demonstrated a good safety and tolerability profile with adverse events consistent with previous studies and with other vaptans.
Clinicaltrials.gov has more information about the ELiSA Study.
Clinical Trials/Compassionate Use
Palladio Biosciences is committed to improving the lives of patients by bringing forward new therapies for orphan and rare diseases of the kidney. The conduct of clinical studies is the primary route to scientifically understanding the value of new drugs in the treatment of kidney disease. Palladio Biosciences will pursue such clinical trials to provide the safety and efficacy data necessary to obtain approval from regulatory authorities to market such drugs.
The most productive route for patients to gain access to new medications before they are approved is by participating in clinical trials. It is recognized, however, that under certain rare and particular situations there will be individuals with a bona fide need to gain access to a new therapy who do not meet the traditional entry criteria for an available clinical trial. Physicians caring for such patients with serious or life-threatening conditions can seek special access to investigational medicines through expanded access pathways (also, referred to as compassionate use) outside of the clinical trial process. Palladio will consider such requests from a physician when the following circumstances are satisfied:
- The patient(s) for whom expanded access or compassionate use is sought must meet all of the following conditions:
- The patient is suffering from a serious, disabling, painful, or life-threatening disease or condition;
- The patient has undergone appropriate standard treatments without success or tolerability; no comparable or satisfactory alternative treatment is available or no standard treatment exists for the disease or condition;
- The patient is ineligible for participation in any ongoing clinical study of the unapproved product; and
- The patient meets any other relevant medical criteria for expanded access or compassionate use of the investigational product, as established by Palladio Biosciences.
- There are meaningful human clinical data to support an assessment that the potential benefits to the patient outweigh the risks to the patient.
- Providing the unapproved product for expanded access or compassionate use will not interfere with development of the product.
- Expanded access or compassionate use is allowed under all applicable legal and regulatory requirements.
The requesting licensed physician will submit the following information to Palladio Biosciences:
- Demographic information on the proposed patient seeking expanded access;
- Medical history, including all treatments administered for the relevant use and the clinical course with those treatments;
- Description of the patient’s prognosis;
- Reason for requesting expanded access;
- Plan of treatment if expanded access is granted, including safety monitoring and periodic assessment of benefit/risk ratio
A team of Palladio Biosciences scientists and physicians will review the information with the following points in mind:
- Is the scientific/clinical rationale for the proposed use valid?
- Is there the potential of including the patient in an ongoing Palladio clinical trial?
- Is the proposed use through expanded access compatible with Palladio’s research objectives?
- Can clinical drug supplies be made available for this expanded access request?
- What experience does the physician/investigator have with the requested drug and clinical investigation?
If the Palladio Biosciences team makes a recommendation for expanded access, the Board of Directors of Palladio Biosciences will review the request and determine whether to approve it or not. The results of that review will be communicated to the physician submitting the expanded access request. If the request has been denied, no further appeal will be allowed.
If the Palladio Biosciences team denies the request for expanded access, it will communicate that result to the requesting physician. Again, denial of the request by the Palladio Biosciences team cannot be appealed.
Requests for expanded access or to discuss eligibility or answer other questions may be submitted by a treating physician to the attention of Dr. Neil Shusterman at firstname.lastname@example.org. Acknowledgement of the request will be within 5 business days after receipt.