Etonogestrel+ Ethinyl Estradiol + QGriffithsin Intravaginal Ring (EEQ IVR)

Sponsor(s)

No sponsor indicated

Partnerships

No partner indicated

Type of technology

Intra-vaginal ring

Administration route

Topical (Vaginal)

Development state and regulatory approval

Estrogens

Phase I

Under clinical investigation

Description

The EEG intravaginal ring (IVR) is a multipurpose prevention technology providing 90-day contraception and HIV PrEP. It contains etonogestrel (ETG), ethinyl estradiol (EE), and the anti-HIV lectin griffithsin (QGRFT) within a silicone matrix. QGRFT is a potent natural antiviral agent. Further, Sustained release is enabled by silk fibroin, supporting controlled delivery. This system offers effective contraception and may reduce HIV transmission and resistance development.

Technology highlight

1) 90 day sustained release silicone based intravaginal ring 2) Anti-HIV and Contraceptive MPT 3) Self adminstered

Technology main components

1) Etonogestrel 2) Ethinyl Estradiol 3) QGriffithsin (QGRFT) 4) Silk fibroin

Information on the raw materials sourcing, availability and anticipated price

Not provided

Delivery device(s)

Intravaginal pod shaped silicone based ring

API desired features

Water-insoluble molecules

Small molecules

Cervical anesthetics such as lidocaine, contraceptives such as 17O-ethinyl-levonogestrel 17b-hydroxy-estra-4,9,11-trien-3-one, estradiol. Etonogestrel, levonogestrel, medroxyprogesterone acetate, NESTORONE, norethindrone, progesterone, estrogen receptor modulators such as RU-486, anti-endometriosis drugs such as Terbutaline, antivirals such as acyclovir and gancy clovir; blood flow increasing drugs like Sildenafil: labor inducing drugs like misoprostol; preterm labor drugs like indomethacin; overactive bladder drugs like oxybutynin, morning sickness drugs such as Bromocriptine.

Proteins

Prefered molecular weight - 2,000 to 5,000.000 Da. High molecular weight water soluble polymers such as Sulfated polysaccharides such as carrageenan, particularly lambda carrageenan. Naturally occuring potent HIV agent - Griffithsin (GRFT), is a 12.8 kDa lectin protein derived from red algae is the choice of protein. Glycoproteins, peptides/polypeptides, peptide hormones, such as insulin, nucleic acid derivatives, including oligonucleotides and aptamers, glucoaminoglycans (GAGs),

Additional solubility data

Not provided

Additional stability data

Not provided

API loading: Maximum drug quantity to be loaded

50-75 wt%

API co-administration

3 different APIs : Not provided

LogP

Not provided

Scale-up prospects

Not provided

Tentative equipment list for manufacturing

Precision weighing balances, sieves / powder feeders, stainless steel storage bins, jacketed mixing vessel, injection molding machine, pellet press / compactor, ultrasonic or mechanical compression tools, drilling / micro-machining system, Thermal sealing unit, drying oven / vacuum dryer, peristaltic filling systems

Manufacturing

Cleanroom (ISO 7/8 depending on product class) Manufacturing includes: 1. Carrageenan formulation (gel / core preparation) + zinc complex formation 2. Formulating IVR using embedded groove technique or aperture-filled ring or central core ring method.

Specific analytical instrument required for characterization of formulation

1. GPC/SEC (molecular weight distribution of carrageenan) 2. FTIR spectroscopy (functional group identification) 3. DSC/TGA (thermal properties) 4. XRD (crystallinity for drug/polymer systems) 5. HPLC / UPLC for NNRTIs (e.g., MIV-150), hormones, etc. 6. ICP-MS / AAS for zinc quantification

957

Identifier

NCT05128136

Link

https://clinicaltrials.gov/study/NCT05128136

Phase

Not provided

Status

Completed

Sponsor

Population Council

More details

The overall aim of this study is to assess different external diameters of intravaginal rings (IVRs) for adherence, preference, and acceptability. To assess these domains, women in male-partnered relationships will use three different size IVRs.

Purpose

A Crossover Study Evaluating 3 Non-medicated Silicone IVRs

Interventions

Intervention 1

Countries

Sites / Institutions

Not provided

Trials dates

Anticipated Start Date
Not provided

Actual Start Date
2022-01-20

Anticipated Date of Last Follow-up
2023-02-08

Estimated Primary Completion Date
Not provided

Estimated Completion Date
Not provided

Actual Primary Completion Date
2022-12-31

Actual Completion Date
2023-01-31

Studied populations

Age Cohort

• Adults

Genders

• Female
• Cisgender female

Accepts pregnant individuals
Unspecified

Accepts lactating individuals
Unspecified

Accepts healthy individuals
Yes

Comments about the studied populations

Inclusion Criteria: Females: * Aged 18-40 years old, inclusive, at Screening based on self-report * Sexually active, defined as having had penile-vaginal sex with a male partner at least four times per month (e.g. once a week), on average, in the three months before Screening * In a mutually monogamous relationship with the same male partner for at least 6 months prior to Screening, based on self-report * Male partner is eligible and consents to participation * Healthy based on medical history and physical exam at Screening * Currently using effective non-vaginal contraception for at least 3 months prior to screening, including injectable, oral contraception, contraceptive patch or sterilization (male or female) based on self-report * HIV-negative per test at Screening * Not pregnant per

Health status

Not provided

Study type

Interventional (clinical trial)

Enrollment

48

Allocation

Randomized

Intervention model

Cross-over assignment

Intervention model description

Not provided

Masking

Open label

Masking description

Not provided

Frequency of administration

Not provided

Studied LA-formulation(s)

Studied route(s) of administration

Use case

PrEP

Key resources

Proprietary excipients used

Not provided

Novel excipients or existing excipients at a concentration above Inactive Ingredients Database (IID) for the specified route of administration

Silk fibroin

Residual solvents used

Not provided

Other features of the technology

• Removable
• Single-use
• Molded

Release properties

Release kinetics are not published yet.

Injectability

Not applicable

Safety

Reported Adverse events (AEs) where 9 Grade 1 AEs (mild). In which, 7 were unrelated to ring use; 2 possibly/unlikely related; Bacterial vaginosis (during 56 mm and 66 mm ring use). Further there were no serious adverse events (SAEs) reported and discontinuations due to adverse events).

Stability

No formal stability studies (ICH, shelf-life, degradation, etc.) reported

Storage conditions and cold-chain related features

No storage conditions (temperature, humidity, shelf-life, packaging) are specified

Therapeutic area(s)

Use case(s)

Use of technology

There are either no relevant patents or these were not yet submitted to LAPaL

Publications

There are no publication

Additional documents

No documents were uploaded

Useful links

• Intravaginal Ring Containing Etonogestrel, Ethinyl Estradiol, and QGriffithsin (EEQ IVR) to Prevent Pregnancy and HIV

	Collaborate for development Consider on a case by case basis, collaborating on developing long acting products with potential significant public health impact, especially for low- and middle-income countries (LMICs), utilising the referred to long-acting technology Not provided
	Share technical information for match-making assessment Provide necessary technical information to a potential partner, under confidentiality agreement, to enable preliminary assessment of whether specific medicines of public health importance in LMICs might be compatible with the referred to long-acting technology to achieve a public health benefit Not provided
	Work with MPP to expand access in LMICs In the event that a product using the referred to long-acting technology is successfully developed, the technology IP holder(s) will work with the Medicines Patent Pool towards putting in place the most appropriate strategy for timely and affordable access in low and middle-income countries, including through licensing Not provided