Phase 1b Single Dose Clinical Trial of a Novel Long-Acting Bispecific Antibody in People With HIV to Inform Development for HIV Pre- and Post-Exposure Prophylaxis

This is an open-label phase 1b clinical trial enrolling people living with HIV (PLWH) who are antiretroviral therapy (ART)-naïve or have not been on ART for > 24 weeks. This study will enroll PLWH to assess the safety, tolerability, and antiviral effect of bispecific and long-acting bNAbs, alone and in combination. The study will be conducted as a single center study at National Institute for Medical Research-Mbeya Medical Research Center (NIMR-MMRC) in Mbeya, Tanzania.
20 PLWH will be sequentially enrolled into one of 5 arms, each arm comprised of 4 participants. Sequential enrollment will occur in the following order:
* Arm 1 will receive standard daily oral ART.
* Arm 2 will receive a single dose of 10E8.4/iMab 600mg intravenous injection (IV).
* Arm 3 will receive a single dose of 10E8.4/iMab 600mg intramuscular injection (IM).
* Arm 4 will receive a single dose of 10E8.4/iMab 1800mg IV.
* Arm 5 will receive a single dose of combination therapy with both 10E8.4/iMab 1800mg IV and VRC07-523LS 1200mg IV.

Start Date28 Nov 2023

Sponsor / Collaborator

Columbia University

[+1]

NCT05495204

/ CompletedNot Applicable

External Comparison of Effectiveness of Ibalizumab in Clinical Trials vs. Other HTE Regimens in OPERA

Among heavily treatment experienced people living with HIV, the virologic effectiveness of ibalizumab + optimized background regimen from two clinical trials will be compared to non-ibalizumab-containing regimens in routine clinical care in the OPERA cohort.

Start Date05 Aug 2022

Sponsor / Collaborator

Epividian, Inc.

[+1]

NCT05388474

/ RecruitingNot Applicable

A Prospective and Retrospective Observational Study of Multidrug-Resistant Patient Outcomes With and Without Ibalizumab in a Real-World Setting: United States

The virological efficacy of ibalizumab has been clearly demonstrated in multiple clinical trials. This study will expand ibalizumab's clinical data set and allow a better understanding of the virologic response durability on ARV regimens with or without ibalizumab in a heterogeneous real-world patient population. Additional data on the efficacy and safety of ibalizumab and its impact on patient reported outcomes will be captured until study end.
Primary Objective:
To evaluate the long-term efficacy, safety, and durability of ibalizumab in combination with other ARVs by comparing the virologic, immunologic and clinical outcomes of patients receiving ibalizumab treatment versus patients not receiving ibalizumab.
Secondary Objective:
To assess the efficacy of ibalizumab in combination with other antiretrovirals by comparing the virologic, immunologic, clinical and patient reported outcomes of patients before and after they receive ibalizumab treatment.
To assess the long-term safety and tolerability of ibalizumab.
Other Objectives:
To assess risk factors/predictors of virologic and immunologic response. To assess efficacy and safety in special populations that enroll.

Start Date22 Mar 2022

Sponsor / Collaborator

Theratechnologies, Inc.

[+2]

100 Clinical Results associated with Ibalizumab-UIYK

100 Translational Medicine associated with Ibalizumab-UIYK

100 Patents (Medical) associated with Ibalizumab-UIYK

Literatures (Medical) associated with Ibalizumab-UIYK

01 Mar 2025·AIDS

Emerging integrase resistance in an international perinatal virtual clinic

Article

Author: Foster, Caroline ; Mackie, Nicola E. ; Lyall, Hermione ; Bailey, Angela ; Tickner, Neil ; Glenn, Jessica ; Welch, Steven ; Milheiro Silva, Tiago ; Bamford, Alasdair ; Simon, Katie ; Levin, Leon ; Kenny, Julia ; Turkova, Anna ; Eni-Olotu, Ayolola

Objective::

The aim of this study was to identify the prevalence of emergent integrase drug resistance mutations (INSTI-DRMs) in international referrals to a perinatal virtual clinic (PVC).

Design::

A retrospective cohort study.

Setting::

Monthly multidisciplinary PVC reviewing complex case management for children and adolescents with perinatally acquired HIV (CAWHIV).

Participants::

One hundred fourteen cases referred for virological failure between October 2018 and January 2024.

Main outcome measures::

Data collected included age, sex, weight, country of residence, antiretroviral therapy (ART) history, HIV viral load, CD4+ cell count, and comorbidities. Resistance mutations were interpreted using the Stanford HIV Drug Resistance database with emergent major INSTI-DRMs described.

Results::

Of 114 referrals, 103 (90%) had resistance sequences available. Prior INSTI exposure was documented in 61/103 (59%) with 19/61 (31%) having INSTI-DRMs. For these 19, median (IQR) age was 11 years (6–14), weight 25 kg (17–50), CD4+ cell count 485 cells/μl (153–805), and viral load 84 000 copies/ml (2380–137 000). Twelve of 19 (65%) were from low/middle-income countries (LMIC), 6/19 (32%) had current AIDS diagnoses with 14/19 (74%) referred from 2022 onwards. There were a median three prior regimens with 13/19 (68%) having at least 3 class resistance. Two developed INSTI-DRMs on first-line dolutegravir (DTG)-based ART, 17 on second+ line therapy. PVC recommendations were for tenofovir+ lamivudine/emtricitabine (six split adult tablets) with boosted darunavir [19; six twice daily (b.i.d.)], with b.i.d. DTG (6), plus fostemsavir (1) and ibalizumab (1).

Conclusion::

Although uncommon, INSTI resistance is emerging, mainly in highly treatment experienced CAWHIV from LMIC, highlighting the global need for access to boosted protease inhibitors and novel classes, including formulations for children less than 35 kg.

01 Feb 2025·VIROLOGY

Investigating the combination of Temsavir and entry inhibitors on HIV replication: Synergistic and antagonistic effects observed against various R5-tropic envelopes

Article

Author: Wang, Lingyun ; Su, PeiYi ; Yukselten, Yunus ; Akang, Edidiong ; Sutton, Richard E

HIV is still a pandemic; antiretroviral therapeutics for preventing and treating HIV infection continue to present significant challenges. The demand for new drugs and effective treatments remains ongoing. Here, we investigated the effects of combining Temsavir with other HIV entry inhibitors, including CD4 mimetic BNM-III-170, T20 or enfuvirtide, Ibalizumab, and Maraviroc. Our results show that TMR demonstrates both synergistic and antagonistic activity when combined those other entry inhibitors, depending on the concentration and the specific envelope used. Results suggest that while low-dose combinations, especially using Temsavir and CD4 mimetic, exhibited antagonistic effects, Temsavir showed synergy at low and medium concentrations in combination with enfuvirtide, Ibalizumab, and Maraviroc. These results are promising for the potential of co-administrating antiretrovirals for HIV treatment and highlights the importance of developing advanced antiviral strategies. On the other hand, the variable responses against different R5-tropic envelopes underscore the complexity of designing universally effective combination antiviral therapies.

15 Dec 2024·JAIDS-JOURNAL OF ACQUIRED IMMUNE DEFICIENCY SYNDROMES

Efficacy and Safety of 2 Fixed Doses of Ibalizumab Plus Optimized Background Regimen in Treatment-Experienced HIV-Positive Individuals

Article

Author: DeJesus, Edwin ; Anstett, Kaitlin ; Gathe, Joseph C ; Towner, William J. ; Cash, R. Brandon

Background::

Sustained viral suppression in patients with multidrug-resistant (MDR) HIV infection remains difficult; accordingly, agents targeting different steps in the HIV life cycle are needed. Ibalizumab, a humanized immunoglobulin G4 monoclonal antibody, is a cluster of differentiation (CD4)-directed postattachment inhibitor.

Methods::

In this phase 2b study, 113 patients with MDR HIV-1 and limited treatment options were assigned an optimized background regimen (OBR) and randomized to either 800 mg ibalizumab every 2 weeks (q2wk; n = 59) or 2000 mg ibalizumab every 4 weeks (q4wk; n = 54) up to week 24.

Results::

Viral loads (VL) below the detection limit were achieved in 44% and 28% of patients in the 800 mg q2wk and 2000 mg q4wk groups, respectively, at week 24. Mean (SD) VL (log10 copies/mL) decreased from Baseline [4.6 (0.8), 800 mg q2wk; 4.7 (0.7), 2000 mg q4wk] to week 2, with the reduction maintained through week 24 [2.9 (1.5), 800 mg q2wk; 3.2 (1.4), 2000 mg q4wk]. Baseline CD4+ counts were 80.5 and 54.0 cells/μL in the 800 mg q2wk and 2000 mg q4wk groups, respectively. Mean CD4+ T-cell count was increased at week 24 in both groups. No serious adverse events were related to ibalizumab.

Conclusions::

In heavily treatment-experienced patients with HIV (PWH) at a more advanced baseline disease severity, clinically significant response rates at week 24 were achieved with ibalizumab plus OBR. Ibalizumab's unique mechanism of action and lack of cross-resistance to other antiretroviral agents make it an important component of combination treatment regimens for PWH with limited treatment options.

News (Medical) associated with Ibalizumab-UIYK

17 Mar 2025

·www.prnewswire.com

TaiMed Biologics Announces Results from Late-Breaking Phase 2a Data on Long-Acting HIV Maintenance Therapy at CROI 2025

TMB-365/TMB-380 Combination Demonstrates Viral Suspension Without the Need for Susceptibility Screening TaiMed Biologics will reshape HIV treatment management and seeks strategic collaborations with global pharmaceutical partners for the commercialization of its long-acting HIV maintenance therapy TAIPEI, March 17, 2025 /PRNewswire/ -- TaiMed Biologics (4147 TWO), an innovation-driven biotech company, has Phase 2a clinical study evaluating TMB-365/TMB-380 long-acting dual bNAb regimen for HIV maintenance therapy. This regimen, which is the first of its kind, offers a viable alternative to daily oral cART for individuals living with HIV. Continue Reading Key findings from the trial include durable viral suppression, with 94% of participants maintaining RNA levels below 50 copies/mL throughout the treatment period, while only the remaining 6% of participants recorded viral load of 59 copies/mL at end of 24-week treatment. No pre-defined virologic failure, which were defined as two consecutive viral load measurements above 50 copies/mL. The treatment was well-tolerated, with no serious adverse events, no Grade 3 or Grade 4, or acute infusion reactions reported. Additionally, no participants experienced treatment-limiting immune responses to the combination therapy. One of the more remarkable findings of TMB-365/TMB-380 is that it does not require susceptibility screening as the combination's broad breadth of activity and high potency, participants were not pre-screened for susceptibility to either bNAb featured for lowering the barrier to treatment access and ensures a wider range of individuals living with HIV can benefit from the therapy. Additionally, the pharmacokinetic (PK) and immunological markers also support the potential for long-acting viral suppression and stable immune function. This Phase 2a clinical trial was not a double-blind placebo-controlled study, and therefore, no statistical p-values were reported. "We are honored that our study was accepted for late-breaking presentation at CROI, highlighting the high scientific merit and groundbreaking nature of our results among numerous research studies, TMB-365/TMB-380 is the first long-acting mAb combination to achieve a high rate of viral suppression without screening requirements with robust potency, broad coverage and low resistance risk The regimen aims to reduce the frequency of daily dosing, while maintaining treatment's efficacy," said Dr. Jimmy Chang, CEO of TaiMed Biologics. "The global HIV treatment market valued at approximately USD 30 billion annually, with long-acting treatments currently account for only 3% but are projected to increase to over 30-40% in the coming years. The outstanding Phase 2a results position TMB-365/TMB-380 as a frontrunner in this rapidly growing sector, offering clear advantages over existing long-acting treatment options," emphasized by Dr. Jimmy Chang. TaiMed Biologics is actively seeking strategic collaborations with global pharmaceutical partners to support the commercialization of TMB-365/TMB-380. TaiMed Biologics welcomes opportunities to explore potential collaborations with global pharmaceutical partners to advance the commercialization of TMB-365/TMB-380 For more information, please contact: Jonathan Ho, [email protected]. About TaiMed Biologics Founded in 2007, TaiMed Biologics (4147.TWO) is a leading commercial-stage biotechnology company focused on developing innovative therapies for HIV treatment. The company successfully launched ibalizumab (Trogarzo®), the world's first and only FDA-approved monoclonal antibody for HIV and continues to pioneer long-acting biologics and antibody-drug conjugates (ADCs). TaiMed Biologics also offers comprehensive contract development and manufacturing (CDMO) services and is publicly traded on the OTC Market since November 2015, currently part of the MSCI Small Cap Index. SOURCE TaiMed Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Drug Approval

12 Mar 2025

·www.globenewswire.com

Theratechnologies Presents Encouraging Virologic Suppression Data from the PROMISE-US Trial of Ibalizumab at CROI

Results show similar levels of virus undetectability in patients on ibalizumab-containing regimens as in controls, despite greater baseline severity of HIV Ibalizumab continues to demonstrate long-term efficacy and safety as part of combination antiretroviral therapy in heavily treatment-experienced people with multidrug resistant HIV MONTREAL, March 12, 2025 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a commercial-stage biopharmaceutical company, today presented data from a real-world, observational, registry study demonstrating the efficacy and safety of ibalizumab in reducing HIV RNA to undetectable levels in heavily treatment-experienced (HTE) patients with multidrug resistant HIV. In a poster session at the 2025 Conference on Retroviruses and Opportunistic Infections (CROI) in San Francisco, Calif., investigators from the Prospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US) reported that patients treated with regimens containing ibalizumab achieved undetectable HIV viral load levels at similar rates as those receiving non-ibalizumab-containing regimens, despite displaying characteristics indicative of more severe HIV disease at baseline. “The availability of long-term injectable therapies has not eliminated the phenomenon of multidrug resistance, and heavily treatment-experienced people with HIV deserve fully suppressive antiretroviral regimens that can help them establish and maintain virologic control,” stated presenting author Smitha Gudipati, MD, an infectious disease specialist at Henry Ford Hospital in Detroit, Mich. “We are therefore encouraged to see such impressive reductions in viremia in patients whose regimens include ibalizumab, despite having lower CD4 counts and higher viral loads at baseline than the non-ibalizumab control group.” Theratechnologies previously announced the study design and baseline characteristics of participants in PROMISE-US (ClinicalTrials.gov identifier: NCT05388474), a phase 4, multicenter, retrospective and prospective, observational, non-interventional registry study. The trial is designed to assess risk factors and predictors of virologic and immunologic response in HTE people with HIV (PWH) and specific sub-populations. Its primary objective is to evaluate the long-term efficacy and durability of ibalizumab, a CD4-directed post-attachment inhibitor of HIV, in combination with other antiretroviral therapies by comparing the clinical outcomes of patients receiving ibalizumab (Cohort 2) versus matched patients not receiving ibalizumab (Cohort 1). At CROI, the PROMISE-US investigators presented an interim, unmatched subgroup analysis comprising 112 participants, of whom 70 were enrolled in Cohort 1 and 42 in Cohort 2. At baseline, 27 of participants in Cohort 1 and 25 in Cohort 2 were viremic, defined as viral load above 50 RNA copies/mL (39% and 57%, respectively; p=0.0279). Three-quarters (74%) of participants in Cohort 1 who had baseline viremia had more than 200 CD4 T-cells/mm3 at baseline, compared to only 44% of those in Cohort 2 who were viremic at baseline (p=0.0376). Among those with baseline viremia, 50% of Cohort 1 participants and 47% in Cohort 2 achieved undetectable viral load (≤50 RNA copies/mL) after six months of treatment (p=0.873). At 12 months, viral load was undetectable in 53% of Cohort 1 participants and in 42% of those in Cohort 2 (p=0.0.524). Ibalizumab was well-tolerated with no infusion reactions reported and no discontinuation of treatment by participants in Cohort 2 due to a treatment emergent adverse event. “The PROMISE-US trial is the first registry to capture long-term clinical outcomes for highly treatment-experienced patients with multidrug-resistant HIV in a real-world setting and in the US specifically,” commented Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. “The data presented today suggest that ibalizumab can be a critical component of therapeutic regimens in the modern antiretroviral era. We look forward to validating these interim findings as we continue to enroll and monitor patients in this ongoing study.” About Theratechnologies Theratechnologies (TSX: TH) (NASDAQ: THTX) is a specialty biopharmaceutical company focused on the commercialization of innovative therapies that have the potential to redefine standards of care. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and X. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”), within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the long-term safety and efficacy of ibalizumab, the effect of ibalizumab on the reductions of viremia and the use of ibalizumab as a component of therapeutic regimens in the modern antiretroviral era. Forward-looking statements involve a number of assumptions, risks and uncertainties. Some of these assumptions include, but are not limited to, the fact that patients receiving ibalizumab will achieve undetectable HIV viral load levels. The Company refers current and potential investors to the “Risk Factors” section of its Annual Information Form filed under the Company’s Form 20-F dated February 26, 2025 available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings for the risks associated with the business of Theratechnologies. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com1-514-336-7800 Investor Inquiries:Joanne ChoiSenior Director, Investor Relationsjchoi@theratech.com1-551-261-0401

Clinical ResultPhase 3Phase 2

17 Oct 2024

·www.globenewswire.com

Theratechnologies Unveils Study Design and Baseline Characteristics of PROMISE-US Trial of Ibalizumab in Heavily Treatment-Experienced People with HIV and Multidrug Resistance

Baseline Data Show More Frequent Selection of Ibalizumab in Patients with Lower CD4 Counts and Higher Viral Loads, Compared to Other RegimensMONTREAL, Oct. 17, 2024 (GLOBE NEWSWIRE) -- Theratechnologies Inc. (“Theratechnologies” or the “Company”) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on development and commercialization of innovative therapies, today disclosed the study design and baseline characteristics of participants in the Prospective Observational Study of Multidrug-Resistant Patient Outcomes with and without Ibalizumab in a Real-World Setting: United States (PROMISE-US). The study seeks to fill a critical gap in long-term clinical outcomes for heavily treatment-experienced (HTE) people with HIV (PWH), while illuminating factors contributing to maintenance of virologic control. In a poster presentation at IDWeek 2024 in Los Angeles, Calif., PROMISE-US investigators reported that ibalizumab, a CD4-directed post-attachment inhibitor of HIV, was more frequently selected for use in advanced, HTE participants with lower CD4 cell counts and higher viral loads, compared to regimens not containing ibalizumab. Despite the use in more advanced patients, ibalizumab demonstrated good durability, with the majority of subjects staying on therapy for more than 24 months. “The phenomenon of multidrug resistance is most prevalent in persons with HIV with extensive prior exposure to antiretroviral therapies, making it challenging to establish and maintain virologic control, due to the limited availability of medications for constructing a fully suppressive regimen,” stated presenting author, Charlotte-Paige Rolle, M.D., MPH, Director of Research Operations, Orlando Immunology Center. “Given the need for more options to treat this subset of PWH and to understand how they respond to treatment, we designed PROMISE-US to compare the long-term efficacy and safety of ibalizumab-based regimens to other regimens used in heavily treatment-experienced individuals in the real-world setting.” PROMISE-US (ClinicalTrials.gov identifier: NCT05388474) is a phase 4, multicenter, retrospective and prospective, observational, non-interventional registry study. The study is designed to assess risk factors and predictors of virologic and immunologic response in HTE PWH and specific sub-populations and is the first real-world registry study that captures patient-reported outcomes such as satisfaction and adherence to treatment in this specific patient population. The study’s primary objective is to evaluate the long-term efficacy and durability of ibalizumab in combination with other antiretroviral (ARV) therapies by comparing the clinical outcomes of patients receiving ibalizumab (Cohort 2) versus matched patients not receiving ibalizumab (Cohort 1). As of November 2023, a total of 114 participants were enrolled: 70 in Cohort 1, 42 on ibalizumab, and two screen failures. Baseline characteristics, including race, ethnicity, sex, gender, and time since diagnosis, were well matched between both cohorts. The use of ibalizumab was associated with HTE patients with higher viral loads (p = 0.0629) and declining CD4 T cells (p = 0.001), compared to those subjects not taking ibalizumab. The PROMISE-US researchers also investigated the use of the capsid inhibitor lenacapavir, for HTE PWH, in combination with ibalizumab. This subset of Cohort 2 exhibited the highest viral loads and lowest CD4 counts at baseline, although the sample size is small (n = 12). As of the time of analysis, 80% of participants (n = 21) in Cohort 2 had remained on ibalizumab for greater than 12 months. Ibalizumab was well tolerated, with no infusion reactions reported. “As more agents with novel mechanisms of action become available and HIV researchers and clinicians are paying increasing attention to multidrug resistance, we continue to analyze data from PROMISE-US to understand the long-term safety and efficacy of ibalizumab, particularly with regard to its suitability for combination with long-term injectable therapies,” said Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer of Theratechnologies. “We also seek further understanding of the factors that contribute to maintaining virologic response in heavily treatment-experienced individuals with HIV, a population with a high unmet need for reliable, sustainable antiretroviral therapy. We are proud to be the first company to establish a registry to capture long-term clinical outcomes for heavily treatment-experienced patients with multidrug-resistant HIV-1 in a real-world setting and look forward to sharing additional data from this ongoing study.” IDWeek 2024 is the joint annual meeting of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, the Pediatric Infectious Diseases Society, and the Society of Infectious Diseases Pharmacists. About TheratechnologiesTheratechnologies (TSX: TH) (NASDAQ: THTX) is a biopharmaceutical company focused on the development and commercialization of innovative therapies addressing unmet medical needs. Further information about Theratechnologies is available on the Company's website at www.theratech.com, on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov. Follow Theratechnologies on Linkedin and Twitter. Forward-Looking Information This press release contains forward-looking statements and forward-looking information (collectively, the “Forward-Looking Statements”), within the meaning of applicable securities laws, that are based on our management’s beliefs and assumptions and on information currently available to our management. You can identify Forward-Looking Statements by terms such as “may”, “will”, “should”, “could”, “promising”, “would”, “outlook”, “believe”, “plan”, “envisage”, “anticipate”, “expect” and “estimate”, or the negatives of these terms, or variations of them. The Forward-Looking Statements contained in this press release include, but are not limited to, statements regarding the long-term safety and efficacy of ibalizumab, particularly with regard to its suitability for combination with long-term injectable therapies and our understanding of the factors that contribute to maintaining virologic response in heavily treatment-experienced individuals with HIV. Forward-looking statements involve a number of assumptions, risks and uncertainties. The Company refers current and potential investors to the “Risk Factors” section of its Annual Information Form filed under the Company’s Form 20-F dated February 21, 2024 available on SEDAR+ at www.sedarplus.ca and on EDGAR at www.sec.gov under Theratechnologies’ public filings. The reader is cautioned to consider these and other risks and uncertainties carefully and not to put undue reliance on forward-looking statements. Forward-Looking Statements reflect current expectations regarding future events and speak only as of the date of this press release and represent the Company’s expectations as of that date. The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise, except as may be required by applicable law. Contacts: Media inquiries:Julie SchneidermanSenior Director, Communications & Corporate Affairscommunications@theratech.com1-514-336-7800 Investor Inquiries:Philippe DubucSenior Vice President and Chief Financial Officerpdubuc@theratech.com438-315-6608

Phase 2Phase 3Clinical Result

100 Deals associated with Ibalizumab-UIYK

External Link

KEGG	Wiki	ATC	Drug Bank
D09575	Ibalizumab-UIYK	J05AX23	DB12698

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
HIV Infections	United States	Theratechnologies, Inc.	06 Mar 2018

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05388474 (PROMISE-US, Company_Website) Manual	Phase 4	HIV Infections	112	matched patients not receiving ibalizumab (Cohort 1)	zvjggmwnkk(cqqjduzksp) = Among those with baseline viremia, 50% of Cohort 1 participants and 47% in Cohort 2 achieved undetectable viral load (≤50 RNA copies/mL) after six months of treatment (p=0.873). At 12 months, viral load was undetectable in 53% of Cohort 1 participants and in 42% of those in Cohort 2 (p=0.0.524). guqspmiejd (emingmqlis ) View more	Positive	12 Mar 2025
				ibalizumab (Cohort 2)
Biospace Manual	Phase 2/3	HIV Infections	76	ibalizumab 800 mg	ibxguodlwi(fhruxavqqq): 1.98 (95% CI, 1.02 - 3.69) View more	Positive	12 Jul 2023
				non-ibalizumab-containing regimens
NCT00089700 (Pubmed \| J Acquir Immune Defic Syndr)	Phase 2	HIV Infections	82	Ibalizumab 15 mg/kg q2wk	wmaktvzaxg(famiiiqqpf) = No ibalizumab-related serious adverse events were reported gmonspctuy (wypyybvrct )	Positive	01 Apr 2021
				Ibalizumab 10 mg/kg weekly for 9 weeks, then q2wk
NCT02707861 (CTgov)	Phase 3	HIV Infections	79	Optimized Background Regimen+ibalizumab (Cohort 1)	sxhzcubhin = dswakgmiaf snkuseijqg (ioyjcaooxj, sarnlsbanv - ybzmoxbmzz) View more	-	11 Mar 2021
				Optimized Background Regimen+ibalizumab (Cohort 2)	sxhzcubhin = rjmobfgegg snkuseijqg (ioyjcaooxj, qfiazospyr - sfpqhhmaam) View more
TMB-301/TMB-311 (IAS2021)	Not Applicable	HIV Seropositivity	40	Ibalizumab	henpxdctoa(nkwbkusoyi) = ztdwcoxyty azxqapioyu (ruynlleddl, -3.28 4.57)	-	01 Jan 2021
NCT02475629 (CTgov)	Phase 3	HIV Infections	40	Optimized Background Regimen (OBR)+ibalizumab	rspfwdazmo = shibyqpgxp ggzxcnejva (sntlckwxjk, bbxkvkrsyf - ecuvhkfebe) View more	-	19 Mar 2020
IAS2019	Not Applicable	HIV Infections	-	Ibalizumab plus OBR	jwvrfgmugp(lldchtcgcn) = ellgxbxihz karatlvblq (jslhaxxgqo ) View more	-	01 Jan 2019
				OBR alone	jwvrfgmugp(lldchtcgcn) = lzbujjfped karatlvblq (jslhaxxgqo ) View more
NCT02475629 (Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	HIV Infections	40	Ibalizumab	eszeeomkwk(ujgimjetnx) = pzcknwcguw utqijdmige (hcygulniae ) View more	Positive	16 Aug 2018
NCT00784147 (TMB-202, IAS2017)	Not Applicable	HIV Infections	113	Ibalizumab	nfxzwwdcqu(ijwnisprbr) = ilsgwhyxhf zenwjlsxue (hkjcilzzzq )	-	01 Jan 2017
NCT00784147 (TMB-202, CTgov)	Phase 2	HIV Infections	113	Ibalizumab (Ibalizumab 800 mg)	rplortdluz = epiuqkskgc kmcdydyogr (qmrugojpsb, quqeritpkr - agotzhikqb) View more	-	17 Apr 2014
				Ibalizumab (Ibalizumab 2000 mg)	rplortdluz = odzxyvujcy kmcdydyogr (qmrugojpsb, mthbklrwsm - mowfyrqjwf) View more

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