ASCENT-IBO Frequently Asked Questions (FAQs)

No, ARPA-H is unable to comment on any specific approach. The best way to receive feedback on an idea is to submit a solution summary.

For the purposes of this Special Notice, ibogaine does not need to be procured from a US source. However, all ibogaine supply should be appropriate for use in human clinical trials and aligned with the FDA’s requirements.

ARPA-H is unable to comment on any specific approach. The best way to receive feedback on an idea is to submit a solution summary.

As outlined in the Special Notice for ASCENT-IBO, proposed efforts should focus on clinical trial designs that include descriptions of (1) dosing strategy, (2) set and setting, and (3) safety/risk mitigation strategies that promote improved health outcomes and treatment responses. Descriptions of proposed trial designs should include technical justification for the approaches which could include care both during treatment and post-treatment. Please refer to the “Operational Plans for Trial Execution” which states plans for “integration” which is relevant to your question.

As described in ARPA-H-SN-26-156 and ARPA-H-SN-26-158, ARPA-H is only soliciting proposals for the development of ibogaine for treatment-resistant Opioid Use Disorder (OUD) or OUD with an elevated risk of mortality.  As outlined in SN-158, approaches should consider clinically relevant dosing strategies that are associated with therapeutic efficacy and should also consider approaches to mitigate risk and improve safety. That said, the best way to receive feedback from a PM is to submit a solution summary. Each submission will be evaluated on the unique characteristics of the proposed technology.

No, as ASCENT-IBO is focused on Phase I/II clinical development of ibogaine for OUD this would be out of scope. 

We cannot say for certain what FDA/DEA will do. ARPA-H aims to leverage our partnerships with federal organizations to improve the availability of ibogaine for ASCENT-IBO clinical testing, but cannot at this time make any certain commitments to potential wavers. 

Your budget should thus include all relevant costs.

The Special Notice for ASCENT-IBO states, there is a preference for combined Phase I/II studies and, “The ideal study design will simultaneously evaluate safety and efficacy of ibogaine in patient cohorts with OUD at increased risk of mortality.” Thus, while this does not rule out studies in healthy individuals there is a preference for phase 1 safety to be done in the patient population.

ARPA-H can directly fund a foreign entity; however, ARPA-H will prioritize awards to entities that conduct funded work in the U.S., as per 42 USC § 290c(n)(1). Awards will not be made to entities organized under the laws of a covered foreign country, defined in the National Security Act of 1947 (50 U.S.C. § 3059) as Russia, Iran, North Korea, and China. 

All necessary costs should be included in the Solution Summary budget and described in the Basis of Estimate (e.g., highlight the percent of patients to be recruited from geographically underserved areas).