A Solicitation of the National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) for Small Business Innovation Research (SBIR) Contract Proposals

Active
No
Status
Closed
Release Date
August 25th, 2023
Open Date
August 25th, 2023
Due Date(s)
November 14th, 2023
Close Date
November 14th, 2023
Topic No.
NIH/NIAID 134

Topic

Alternatives to Benzathine Penicillin for Treatment of Syphilis

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2023

Summary

The National Institutes of Health (NIH) and The Centers for Disease Control and Prevention (CDC) are seeking proposals for Small Business Innovation Research (SBIR) contracts related to the development of alternatives to Benzathine Penicillin for the treatment of syphilis. The current CDC-recommended therapy for syphilis is injectable Benzathine Penicillin, but there are limitations to its use, such as the lack of an oral form, limited manufacturing facilities, and concerns about anaphylactic reactions. The agencies are looking for innovative solutions that address these barriers and provide alternative therapies to Benzathine Penicillin. The anticipated awards for this solicitation are 2-3, with a budget of $300,000 for Phase I (up to one year) and $1,500,000 for Phase II (up to three years). The deadline for proposal submission is November 14, 2023. For more information, please refer to the solicitation link: link.

Description

Fast-Track proposals will be accepted Direct-to-Phase II proposals will be accepted Number of anticipated awards: 2-3 Budget (total costs): Phase I: $300,000 for up to one year; Phase II: $1,500,000 for up to 3 years Background Injectable benzathine penicillin (BPG) is currently the only CDC-recommended first line therapy for treatment of infection with Treponema pallidum (syphilis) in all populations, including pregnant persons and infants. There are several barriers that limit use of BPG: • BPG is not available orally. • Only a limited number of facilities in a single country currently manufacture the raw active pharmaceutical ingredient which means the supply chain can easily be disrupted and shortages of BPG are common in the US and globally. Page 119 • BPG may sometimes not be administered at lower-level facilities or by non-physician medical staff out of fear of anaphylactic reactions that might require referral to a tertiary care center. Alternative therapies to BPG that address some of these barriers are urgently needed, as acquired and congenital syphilis rates are increasing rapidly. WHO estimates over six million persons per year are infected with syphilis, and many more are treated presumptively for syphilis. Clinicians and health systems are eager for BPG alternatives. Recent advances in the ability to culture T. pallidum mean that identification of alternatives to BPG is now more feasible than has been possible in the past.