Theratechnologies Presents Encouraging Virologic Suppression Data from the PROMISE-US Trial of Ibalizumab at CROI
Theratechnologies (NASDAQ: THTX) presented encouraging data from the PROMISE-US trial of ibalizumab for HIV treatment at CROI 2025. The real-world observational study demonstrated that patients receiving ibalizumab-containing regimens achieved similar viral suppression rates compared to control groups, despite having more severe baseline conditions.
The interim analysis included 112 participants (70 in control Cohort 1, 42 in ibalizumab Cohort 2). Among viremic patients, 47% in the ibalizumab group achieved undetectable viral load after 6 months, compared to 50% in controls. At 12 months, undetectable rates were 42% for ibalizumab versus 53% for controls.
Notably, ibalizumab-treated patients started with more challenging baseline characteristics, including lower CD4 counts and higher viral loads. The drug demonstrated good tolerability with no infusion reactions or treatment discontinuations due to adverse events.
Theratechnologies (NASDAQ: THTX) ha presentato dati incoraggianti dal trial PROMISE-US sull'ibalizumab per il trattamento dell'HIV al CROI 2025. Lo studio osservazionale nel mondo reale ha dimostrato che i pazienti che ricevevano regimi contenenti ibalizumab hanno raggiunto tassi di soppressione virale simili rispetto ai gruppi di controllo, nonostante avessero condizioni di base più severe.
L'analisi intermedia ha incluso 112 partecipanti (70 nel gruppo di controllo Coorte 1, 42 nella coorte di ibalizumab Coorte 2). Tra i pazienti viremi, il 47% del gruppo ibalizumab ha raggiunto una carica virale non rilevabile dopo 6 mesi, rispetto al 50% nei controlli. A 12 mesi, i tassi di non rilevabilità erano del 42% per ibalizumab contro il 53% per i controlli.
È importante notare che i pazienti trattati con ibalizumab hanno iniziato con caratteristiche di base più impegnative, inclusi conteggi CD4 più bassi e cariche virali più elevate. Il farmaco ha dimostrato una buona tollerabilità senza reazioni da infusione o interruzioni del trattamento a causa di eventi avversi.
Theratechnologies (NASDAQ: THTX) presentó datos alentadores del ensayo PROMISE-US sobre ibalizumab para el tratamiento del VIH en CROI 2025. El estudio observacional en el mundo real demostró que los pacientes que recibieron regímenes que contenían ibalizumab lograron tasas de supresión viral similares a las de los grupos de control, a pesar de tener condiciones basales más severas.
El análisis intermedio incluyó a 112 participantes (70 en el grupo de control Cohorte 1, 42 en la Cohorte 2 de ibalizumab). Entre los pacientes viremicos, el 47% en el grupo de ibalizumab alcanzó una carga viral indetectable después de 6 meses, en comparación con el 50% en los controles. A los 12 meses, las tasas de indetectabilidad fueron del 42% para ibalizumab frente al 53% para los controles.
Es notable que los pacientes tratados con ibalizumab comenzaron con características basales más desafiantes, incluidos conteos de CD4 más bajos y cargas virales más altas. El fármaco demostró buena tolerabilidad sin reacciones a la infusión ni interrupciones del tratamiento debido a eventos adversos.
Theratechnologies (NASDAQ: THTX)는 CROI 2025에서 HIV 치료를 위한 ibalizumab의 PROMISE-US 시험에서 고무적인 데이터를 발표했습니다. 실제 관찰 연구에서는 ibalizumab이 포함된 요법을 받는 환자들이 대조군에 비해 유사한 바이러스 억제율을 달성했으며, 기저 상태가 더 심각했음에도 불구하고 결과가 나타났습니다.
중간 분석에는 112명의 참가자(대조군 1군 70명, ibalizumab 2군 42명)가 포함되었습니다. 바이러스가 있는 환자 중 ibalizumab 그룹의 47%가 6개월 후에 검출되지 않는 바이러스 로드를 달성했으며, 대조군에서는 50%가 해당되었습니다. 12개월 후, ibalizumab의 검출되지 않는 비율은 42%였고 대조군은 53%였습니다.
특히, ibalizumab 치료를 받은 환자들은 CD4 수치가 낮고 바이러스 로드가 높은 등 더 도전적인 기저 특성을 가지고 시작했습니다. 이 약물은 부작용으로 인한 주입 반응이나 치료 중단 없이 좋은 내약성을 보였습니다.
Theratechnologies (NASDAQ: THTX) a présenté des données encourageantes de l'essai PROMISE-US sur l'ibalizumab pour le traitement du VIH lors du CROI 2025. L'étude d'observation dans le monde réel a démontré que les patients recevant des régimes contenant de l'ibalizumab ont atteint des taux de suppression virale similaires à ceux des groupes de contrôle, malgré des conditions de base plus sévères.
L'analyse intermédiaire a inclus 112 participants (70 dans le groupe de contrôle Cohorte 1, 42 dans la cohorte d'ibalizumab Cohorte 2). Parmi les patients virémiques, 47% du groupe ibalizumab ont atteint une charge virale indétectable après 6 mois, contre 50% dans les contrôles. À 12 mois, les taux d'indétectabilité étaient de 42% pour l'ibalizumab contre 53% pour les contrôles.
Il est à noter que les patients traités par ibalizumab ont commencé avec des caractéristiques de base plus difficiles, notamment des comptes de CD4 plus bas et des charges virales plus élevées. Le médicament a montré une bonne tolérance sans réactions à l'infusion ni interruptions de traitement en raison d'événements indésirables.
Theratechnologies (NASDAQ: THTX) hat ermutigende Daten aus der PROMISE-US-Studie zu Ibalizumab zur HIV-Behandlung auf der CROI 2025 vorgestellt. Die realweltliche Beobachtungsstudie zeigte, dass Patienten, die Ibalizumab-haltige Therapien erhielten, ähnliche Virusunterdrückungsraten wie die Kontrollgruppen erreichten, obwohl sie schwerwiegendere Ausgangsbedingungen hatten.
Die Zwischenanalyse umfasste 112 Teilnehmer (70 in der Kontrollgruppe Kohorte 1, 42 in der Ibalizumab-Kohorte 2). Unter den viremierten Patienten erreichten 47% der Ibalizumab-Gruppe nach 6 Monaten eine nicht nachweisbare Viruslast, verglichen mit 50% in den Kontrollen. Nach 12 Monaten lagen die nicht nachweisbaren Raten bei 42% für Ibalizumab im Vergleich zu 53% für die Kontrollen.
Bemerkenswert ist, dass die mit Ibalizumab behandelten Patienten mit herausfordernden Ausgangsmerkmalen begannen, darunter niedrigere CD4-Zahlen und höhere Viruslasten. Das Medikament zeigte eine gute Verträglichkeit, ohne Infusionsreaktionen oder Behandlungsabbrüche aufgrund von unerwünschten Ereignissen.
- Demonstrated efficacy in treating severe HIV cases with similar viral suppression rates to controls
- Strong safety profile with no infusion reactions or treatment discontinuations
- Successfully treated patients with more challenging baseline characteristics
- Slightly lower 12-month viral suppression rate (42%) compared to control group (53%)
Insights
The PROMISE-US trial data presented by Theratechnologies at CROI 2025 offers meaningful clinical validation for ibalizumab in heavily treatment-experienced (HTE) HIV patients with multidrug resistance. The results demonstrate that ibalizumab-containing regimens achieved comparable virologic suppression rates to control treatments, despite the ibalizumab group having significantly worse baseline disease characteristics.
What makes these findings particularly notable is the context: patients in the ibalizumab cohort had lower CD4 counts and higher baseline viral loads, yet still achieved undetectable viral loads (
From a commercial perspective, this real-world evidence reinforces ibalizumab's position in a specialized but critical market segment. While the HTE population represents a relatively small subset of HIV patients, these individuals have treatment options and typically require more intensive healthcare resources. The data helps secure ibalizumab's place in treatment protocols and potentially supports reimbursement decisions for this premium-priced therapy.
For Theratechnologies, these results represent an incremental positive that validates an existing revenue stream rather than opening entirely new markets. As the first registry capturing long-term outcomes in this population, PROMISE-US provides clinicians with confidence in ibalizumab's durability and reinforces its role as a vital component in constructing effective regimens for multidrug-resistant HIV.
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 (
Among those with baseline viremia,
“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 Schneiderman
Senior Director, Communications & Corporate Affairs
communications@theratech.com
1-514-336-7800
Investor Inquiries:
Joanne Choi
Senior Director, Investor Relations
jchoi@theratech.com
1-551-261-0401
FAQ
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