# Development of a Novel Oral Antibiotic for the Treatment of Drug Resistant Gonorrhea

> **NIH NIH R44** · AIMMAX THERAPEUTICS, INC. · 2024 · $999,991

## Abstract

PROJECT SUMMARY / ABSTRACT
The CDC has identified Neisseria gonorrhoeae as a pathogen of the highest threat level (“Urgent Threat”) to
the US public health. Currently there is only a single recommended agent remaining on the CDC treatment
guidelines, an intramuscular injection of the extended spectrum cephalosporin, ceftriaxone. However, in the
past decade, reports of resistance to ceftriaxone have appeared across the globe. If one of these strains were
to disseminate widely, we would be facing an era of untreatable gonorrhea. Untreated infections can cause
serious and life-threatening sequelae. Thus, developing new antibiotics without cross-resistance to the current
therapeutics is of critical importance to public health. Between 20 and 40% of individuals infected with N.
gonorrhoeae are co-infected with Chlamydia trachomatis, a predominantly asymptomatic infection that can
have devastating long-term effects on reproductive health and fertility if not treated. Ceftriaxone is not active
against C. trachomatis and the clinical signs and symptoms of gonorrhea and chlamydia are indistinguishable
from one another. Therefore, unless chlamydia can be excluded by a laboratory diagnosis, empiric treatment
for gonorrhea typically involves administration of two different classes of antibiotics in order to cover both
pathogens. A single oral antibiotic effective against both infections would change the current treatment
paradigm, improving adherence to treatment as well as reducing the impact that dual antibiotic therapy can
have on promoting resistance in co-infecting pathogens and commensal organisms. Furthermore, as an oral
antibiotic, it would provide a much-needed treatment option to patients and physicians and allow for expedited
partner therapy. AimMax Therapeutics has discovered a novel antibiotic with activity against N. gonorrhoeae
that is comparable to ceftriaxone. It has demonstrated potent activity against multidrug- and pan-resistant N.
gonorrhoeae isolates, including isolates resistant to ceftriaxone, with no evidence of cross-resistance to
existing classes. The overall goal of this proposed FastTrack SBIR application is to develop a novel oral
antibiotic for the treatment of gonorrhea as the top priority, and if suitable, for the treatment of chlamydia also,
the two most common bacterial sexually transmitted infections in the US. The studies proposed herein will
confirm the suitability of this new class of antibiotic for the treatment of gonorrhea and chlamydia, identify a
formulation that delivers optimal oral bioavailability and plasma exposure to provide effective treatment, and
advance development towards filing of an IND. Rising antibiotic resistance combined with ease of
transmission, risks for outbreaks, and lack of second-line treatment options, all point to the critical need to
identify new antibiotics for the treatment of gonorrhea and expeditiously advance their development to the
clinic.

## Key facts

- **NIH application ID:** 10873308
- **Project number:** 5R44AI170150-03
- **Recipient organization:** AIMMAX THERAPEUTICS, INC.
- **Principal Investigator:** Laurene Wang
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $999,991
- **Award type:** 5
- **Project period:** 2022-08-08 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10873308

## Citation

> US National Institutes of Health, RePORTER application 10873308, Development of a Novel Oral Antibiotic for the Treatment of Drug Resistant Gonorrhea (5R44AI170150-03). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10873308. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*