Aligos is dedicated to developing potential new treatments for serious and life-threatening diseases. To accomplish this goal, we must utilize our resources efficiently to focus on advancing our investigational products through the clinical development process. In this way, we are currently prioritizing enrolling and conducting the clinical trials necessary to generate data sufficient to apply for, and potentially gain, regulatory approvals to make our medicines available to all patients with the conditions for which we may obtain approval. We are privileged to collaborate with clinical investigators and patients who participate in our studies to further these aims.

We recognize that there are seriously ill patients who are not and will not be eligible for Aligos-sponsored clinical trials and do not and may not have options for alternative therapies, including investigational therapies in trials being conducted by other sponsors. However, at this time, to further our goal of bringing these potential therapies to patients as quickly and efficiently as possible, Aligos does not provide any of its product candidates to patients via expanded access (also referred to as compassionate use).

We have considered many factors in arriving at this determination, including making reasonable assessments of potential risk versus benefit for patients outside the clinical trial setting, and our ability to maintain supply for clinical trials, from enrollment to completion. As the clinical development programs progress, it is possible that our assessment of these factors may result in a decision to change this policy and to consider expanded access requests, in which case Aligos would update this policy.

In the event that Aligos decides to consider offering expanded access use for any of its investigational product candidates in the future, the request for expanded access would need to be initiated by a licensed physician or healthcare provider (HCP) and include sufficient supporting detail to enable Aligos to evaluate the request against all relevant criteria under the law and as set forth in any updated policy. For example, if, in the future, Aligos were to offer expanded access to its investigational products, the criteria it may consider could include the following:

• The severity of the patient’s condition;
• Any available alternative treatments or clinical trials that may be available to the patient, and how satisfactory those alternatives may be;
• The then-current stage of clinical development of the investigational drug and whether the data generated at the time of the request are sufficient to support expanded access at the dose requested and for the particular patient’s condition (i.e., a benefit/risk assessment in light of available data);
• The impact of making the investigational drug available on the continued conduct of clinical trials (e.g., the potential for a negative impact on supply or delay in clinical development), FDA regulatory review, or potential approval of the investigational drug;
• The experience and qualifications of the requesting physician or HCP, as well as the requesting physician or HCP’s acceptance of regulatory responsibility and compliance with Aligos-specific requirements;
• The location of the patient and the associated regulatory regime pursuant to which such access could be granted; and
• Additional criteria regarding the investigational product, its development program, the patient or other circumstances that may, in Aligos’s sole discretion, may impact eligibility.

Even if Aligos updates its policy to consider providing expanded access to its investigational drugs, such policy change would in no way guarantee access to any investigational product by any individual patient, physician, or HCP, as any such request would be evaluated in accordance with criteria established by Aligos and granted or denied in Aligos’s discretion (and in each case subject to compliance with all regulatory requirements).  Moreover, even where Aligos were to amend its policy to consider providing expanded access, and if it were to grant expanded access to any particular patient, it would reserve the right to discontinue the provision of investigational product to a patient at any time, in each case, subject to all regulatory requirements.

If Aligos, in the future, modifies its policy to consider granting expanded access requests on a case by case basis, it would update this policy to provide more detail on the process and timing for acknowledging and responding to such requests. In the meantime, Aligos expects to deny any such requests, and will inform any requesters of its receipt of such requests and this decision to deny such requests promptly upon receipt, and in any event, within 90 days of receipt. More information about Aligos’s clinical trials is available at www.clinicaltrials.gov under NCT numbers NCT06342947, NCT04536337, and NCT05840952.  If you have any questions about our expanded access policy, please contact info@aligos.com.