Compassionate Use / Expanded Access

Our Compassionate Use / Expanded Access Policy

Understanding Compassionate Use During Clinical Development
We understand that patients with serious or life-threatening conditions are often searching for new treatment options. The best way to access investigational therapies is through participation in a clinical trial. Many patients and their families inquire about “compassionate use” (also called expanded access) of our investigational therapy when they do not qualify for an ongoing trial. We deeply appreciate your interest with PHST001 and would like to explain our current position.

What Is a Phase 1 Trial?
A Phase 1 trial is the first step in testing a new drug in humans. During this critical stage:
– We are determining if the drug is safe
– We are identifying the appropriate dosage range
– We are studying how the drug moves through the body
– We are gathering preliminary data on biological activity
– We are working with a very small number of carefully selected participants

At this early stage of development of PHST001, we cannot yet offer our investigational therapy through expanded access or compassionate use programs for several important reasons:

Safety First: We do not yet have sufficient data to understand the full safety profile of our therapy. Our first obligation is to avoid causing harm.

Unknown Effective Dose: We are still determining what dose provides the optimal balance of potential benefit and manageable side effects.

Limited Supply: During early development, we produce only enough of our investigational therapy to support planned clinical trials.

Our Commitment to Patients
We are working diligently to advance our clinical development program as quickly and responsibly as possible. We plan to consider compassionate use programs when we have sufficient safety and preliminary efficacy data

How to Stay Informed?
We will update this page as our clinical program progresses. You can also:
– Check ClinicalTrials.gov for information about our ongoing and upcoming trials
– Discuss clinical trial options with your healthcare provider

We sincerely appreciate your understanding during this critical early development phase. Our goal is to bring safe and effective new therapies to patients as quickly as responsible science allows.

Your healthcare provider can contact us at [email protected].