Tolka AI Therapeutics Expanded Access Waitlist Declaration of Interest

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Tolka AI Therapeutics (http://tolka.ai) is developing a platform for personalized phage therapy against Nontuberculous mycobacterial (NTM) lung disease. Our first target pathogen is M. abscessus. Our candidate drug shows promising effect against M. abscessus in vitro.

Phages are naturally occurring viruses that infect and kill specific bacteria. Phages do not infect human cells, which makes them good candidates to augment or replace antibiotics.

As we prepare our platform for clinical trials, we can support a small number of expanded access requests. Sometimes called “compassionate use”, expanded access is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.

If you have NTM lung disease and want to be added to our expanded access waitlist, please fill in the below declaration of interest and we will get back to you.

All questions are optional except name and email.

For questions, contact questions@tolka.ai

Name *

Email *

Country

Zip Code

Age

How many years have you had NTM Lung Disease?

<1 years

1-2 years

3-5 years

5-10 years

>10 years

Other:

Clear selection

What species of NTM do you have?

(Multiple options possible)

M. abscessus

M. avium complex (MAC)

M. kansasii

M. fortuitum

Don't know

Other:

Are you currently under treatment for NTM lung disease?

yes

Clear selection

Which antibiotics did you take during your latest course of treatment?

(If you are under treatment, list your current treatment regimen)

The FDA allows sponsors to charge patients for materials and labor used to directly prepare their investigational drug (21 CFR 312).

This is to ensure access to investigational drugs when a sponsor can't provide them for free or to broaden access beyond what would be feasible without charging.

If necessary, would you be open to paying for the materials and labor to manufacture your investigational drug?

yes

Other:

Clear selection

Submit

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