Viking Therapeutics Reports New Data from VK2735 Obesity Program at ObesityWeek® 2024
Viking Therapeutics presented new clinical data from its VK2735 obesity program at ObesityWeek® 2024. The oral tablet formulation showed up to 8.2% weight loss from baseline (6.8% placebo-adjusted) after 28 days of dosing, with effects persisting up to Day 57. The subcutaneous formulation demonstrated up to 14.7% weight loss after 13 weeks in the VENTURE Phase 2 study, with maintenance effects lasting up to 7 weeks post-treatment. Both formulations showed encouraging tolerability with mainly mild adverse events. The company plans to discuss the injectable VK2735's clinical path with FDA and initiate a Phase 2 study for the oral formulation by year-end.
Viking Therapeutics ha presentato nuovi dati clinici del suo programma di obesità VK2735 durante l'ObesityWeek® 2024. La formulazione in compresse orali ha mostrato una riduzione del 8,2% del peso rispetto ai valori iniziali (6,8% corretto per effetto placebo) dopo 28 giorni di trattamento, con effetti che persistevano fino al giorno 57. La formulazione sottocutanea ha dimostrato una perdita di peso fino al 14,7% dopo 13 settimane nello studio di Fase 2 VENTURE, con effetti di mantenimento duraturi fino a 7 settimane dopo il trattamento. Entrambe le formulazioni hanno mostrato una tollerabilità incoraggiante, con eventi avversi principalmente lievi. L'azienda prevede di discutere il percorso clinico dell'iniettabile VK2735 con la FDA e di avviare uno studio di Fase 2 per la formulazione orale entro la fine dell'anno.
Viking Therapeutics presentó nuevos datos clínicos de su programa de obesidad VK2735 en ObesityWeek® 2024. La formulación en tabletas orales mostró una pérdida de peso de hasta 8,2% desde el punto de partida (6,8% ajustado por placebo) después de 28 días de tratamiento, con efectos que persistieron hasta el día 57. La formulación subcutánea demostró una pérdida de peso de hasta 14,7% después de 13 semanas en el estudio de Fase 2 VENTURE, con efectos de mantenimiento que duraron hasta 7 semanas después del tratamiento. Ambas formulaciones mostraron una tolerabilidad alentadora con eventos adversos principalmente leves. La compañía planea discutir el camino clínico del VK2735 inyectable con la FDA e iniciar un estudio de Fase 2 para la formulación oral antes de fin de año.
Viking Therapeutics는 ObesityWeek® 2024에서 VK2735 비만 프로그램의 새로운 임상 데이터를 발표했습니다. 경구 정제 제형은 28일 복용 후 기준선에서 8.2%의 체중 감소(플라시보 조정 6.8%)를 보였으며, 효과는 57일째까지 지속되었습니다. 피하 제형은 VENTURE 2상 연구에서 13주 후에 14.7%의 체중 감소를 나타내었으며, 치료 후 최대 7주까지 유지 효과가 지속되었습니다. 두 제형 모두 주로 경미한 부작용으로 고무적인 내약성을 보였습니다. 회사는 VK2735 주사의 임상 경로에 대해 FDA와 논의하고 구강 제형에 대한 2상 연구를 연말까지 시작할 계획입니다.
Viking Therapeutics a présenté de nouvelles données cliniques concernant son programme d'obésité VK2735 lors de l'ObesityWeek® 2024. La formulation en comprimés oraux a montré une perte de poids allant jusqu'à 8,2% par rapport à la ligne de base (6,8% ajusté pour le placebo) après 28 jours de traitement, avec des effets persistants jusqu'au jour 57. La formulation sous-cutanée a démontré une perte de poids de jusqu'à 14,7% après 13 semaines dans l'étude de Phase 2 VENTURE, avec des effets de maintien durant jusqu'à 7 semaines après le traitement. Les deux formulations ont montré une tolérance encourageante avec principalement des effets indésirables légers. La société prévoit de discuter du chemin clinique du VK2735 injectable avec la FDA et d'initier une étude de Phase 2 pour la formulation orale d'ici la fin de l'année.
Viking Therapeutics präsentierte neue klinische Daten zu seinem VK2735-Programm zur Bekämpfung von Fettleibigkeit auf der ObesityWeek® 2024. Die orale Tablettenformulierung zeigte nach 28 Tagen Einnahme einen Gewichtsverlust von bis zu 8,2% im Vergleich zum Ausgangswert (6,8% placebokorrigiert), wobei die Effekte bis Tag 57 anhielten. Die subkutane Formulierung zeigte im VENTURE Phase-2-Studie einen Gewichtsverlust von bis zu 14,7% nach 13 Wochen, mit Erhaltungseffekten, die bis zu 7 Wochen nach der Behandlung andauerten. Beide Formulierungen zeigten eine ermutigende Verträglichkeit mit überwiegend leichten Nebenwirkungen. Das Unternehmen plant, den klinischen Weg des injizierbaren VK2735 mit der FDA zu besprechen und bis Ende des Jahres eine Phase-2-Studie zur oralen Formulierung zu beginnen.
- Oral VK2735 achieved 8.2% weight loss from baseline (6.8% placebo-adjusted) after 28 days
- Subcutaneous VK2735 achieved up to 14.7% weight loss after 13 weeks
- Up to 88% of patients achieved ≥10% weight loss in VENTURE study
- Durable weight loss effects observed up to 7 weeks post-treatment
- Improved glycemic control with 78% of pre-diabetic patients shifting to normoglycemic status
- GI-related adverse events reported (32% mild nausea in oral formulation)
- Vomiting reported in 18% of patients in VENTURE study vs 0% placebo
Insights
The clinical data for VK2735 shows remarkable potential in the competitive obesity drug market. The oral formulation achieved up to
The subcutaneous formulation demonstrated even stronger results with up to
The safety profile appears favorable with mostly mild GI events and no severe nausea reported, potentially differentiating it from competitors in this space.
This data positions Viking strongly in the
The metabolic benefits, particularly the normalization of glycemic status in pre-diabetic patients (78% conversion rate), expands the potential market opportunity. With both oral and injectable formulations advancing to late-stage development, Viking could capture significant market share from established players like Novo Nordisk and Eli Lilly.
Up to
Encouraging Tolerability Through 100 mg Daily Dosing with Oral VK2735; Mild GI-Related Adverse Event Profile
Updated Results from VENTURE Phase 2 Study of Subcutaneous VK2735 Show Durable Effects and Support Potential Monthly Dosing Regimen
Highlights from one poster presentation include new data from the company's Phase 1 multiple ascending dose (MAD) clinical trial of an oral tablet formulation of VK2735 dosed daily for 28 days, including results for the study's 60 mg, 80 mg, and 100 mg daily treatment cohorts. A second poster presentation highlights follow-up results from the company's Phase 2 VENTURE clinical trial of VK2735 demonstrating the treatment's longer-term maintenance effects and pharmacokinetic information.
Poster Presentation #017: First-in-Human Study of an Oral Formulation of the GLP-1/GIP Co-Agonist VK2735 in Healthy Adults
Poster #017 presented updated data from the previously reported 28-day MAD study of the oral tablet formulation of VK2735, including new results from cohorts dosed at 60 mg, 80 mg, and 100 mg daily. These results continued to show positive signs of clinical activity over the 28-day treatment period in this study. Cohorts receiving VK2735 demonstrated dose-dependent reductions in mean body weight from baseline, ranging up to
Change in Body Weight Following 28 Days of Dosing with Oral VK2735
Multiple Ascending Dose Level1,2 | Placebo (n=18) | VK2735 2.5 mg (n=8) | VK2735 5 mg (n=6) | VK2735 10 mg (n=6) | VK2735 20 mg (n=8) | VK2735 40 mg (n=7) | VK2735 60 mg (n=9) | VK2735 80 mg (n=9) | VK2735 100 mg (n=9) |
Mean baseline body weight3 | 98.3 kg | 102.3 kg | 95.3 kg | 97.1 kg | 111.3 kg | 90.0 kg | 107.7 kg | 102.0 kg | 102.7 kg |
Mean change from baseline body weight4,5 | -1.4 kg | -0.3 kg | -0.8 kg | -1.3 kg | -3.6 kg | -4.8 kg | -4.4 kg | -5.3 kg | -8.2 kg |
Mean percent change from baseline4,5 | -1.4 % | -0.3 % | -0.8 % | -1.1 % | -3.5 % | -5.1 % | -4.1 % | -5.2 % | -8.2 % |
Placebo-adjusted mean percent change from baseline4,5 | - | 1.0 % | 0.6 % | 0.3 % | -2.2 % | -3.7 % | -2.7 % | -3.9 % | -6.8 % |
p-value vs. placebo5 | - | - | - | - | 0.0174 | 0.0001 | 0.0026 | <0.0001 | <0.0001 |
Percent reporting ≥ | 0 % | 0 % | 0 % | 0 % | 25 % | 57 % | 38 % | 63 % | 100 % |
p-value vs. placebo6 | - | - | - | - | 0.0933 | 0.0033 | 0.0243 | 0.0011 | <0.0001 |
Notes: 1) Population includes all randomized subjects who received at least one dose of study drug and had at least one planned post-baseline body weight assessment. 2) Subjects treated with VK2735 were titrated to final doses as indicated: 2.5 mg cohort = 2.5 daily x 4 weeks; 5 mg cohort = 2.5 mg daily x 1 wk, 5 mg daily x 3 wks; 10 mg cohort = 5 mg daily x 1 wk, 10 mg daily x 3 wks; 20 mg cohort = 15 mg daily x 1 wk, 20 mg daily x 3 wks; 40 mg cohort = 20 mg daily x 1 wk, 40 mg daily x 3 wks; 60 mg cohort = 40 mg daily x 1 wk, 60 mg daily x 3 wks; 80 mg cohort = 60 mg daily x 1 wk, 80 mg daily x 3 wks; 100 mg cohort = 80 mg daily x 1 wk, 100 mg daily x 3 wks. 3) All subjects enrolled were required to have baseline BMI ≥30 kg/m2. 4) Least squares mean. 5) Two-sided t test using mixed model for repeated measures. 6) Fisher's exact test.
Oral VK2735 continued to demonstrate encouraging safety and tolerability following 28 days of once-daily dosing at doses up to and including 100 mg. The majority (
Common GI-Related Adverse Events Following 28 Days of Dosing with Oral VK2735
Common AEs, No. of Subjects reporting (%) | Placebo (n=19) | VK2735 2.5 mg (n=8) | VK2735 5 mg (n=7) | VK2735 10 mg (n=6) | VK2735 20 mg (n=8) | VK2735 40 mg (n=8) | VK2735 60 mg (n=9) | VK2735 80 mg A (n=9) | VK2735 80 mg B (n=9) | VK2735 100 mg (n=9) | VK2735 Combined (n=73) |
Nausea | |||||||||||
Mild Moderate Severe | 2 ( 0 ( 0 ( | 0 ( 0 ( 0 ( | 1 ( 0 ( 0 ( | 0 ( 0 ( 0 ( | 2 ( 0 ( 0 ( | 2 ( 0 ( 0 ( | 2 ( 0 ( 0 ( | 6 ( 0 ( 0 ( | 4 ( 0 ( 0 ( | 6 ( 0 ( 0 ( | 23 ( 0 ( 0 ( |
Vomiting | 0 (0 %) | 0 (0 %) | 0 (0 %) | 0 (0 %) | 0 (0 %) | 0 (0 %) | 0 (0 %) | 1 (11 %) | 1 (11 %) | 1 (11 %) | 3 (4 %) |
Diarrhea | 4 (21 %) | 0 (0 %) | 0 (0 %) | 0 (0 %) | 1 (13 %) | 0 (0 %) | 1 (11 %) | 1 (11 %) | 1 (11 %) | 1 (11 %) | 5 (7 %) |
Constipation | 3 (16 %) | 0 (0 %) | 0 (0 %) | 0 (0 %) | 0 (0 %) | 0 (0 %) | 3 (33 %) | 2 (22 %) | 1 (11 %) | 4 (44 %) | 10 (14 %) |
Notes: Safety population, includes all randomized subjects who received at least one dose of study drug or placebo. 80 mg Cohort A = 60 mg daily x 1 wk, 80 mg daily x 3 wks; 80 mg Cohort B = 60 mg daily x 1 wk, 80 mg daily x 1 wk, 80 mg QoD x 2 wks.
An exploratory cohort of subjects was also evaluated to assess changes to dose regimen. Subjects in this cohort were titrated to 80 mg daily doses and subsequently transitioned to a lower exposure regimen (80 mg QoD) from Day 15 – 28. Despite reduction in VK2735 exposure, significant reductions in body weight were observed, with subjects reporting mean body weight change of -
Poster Presentation #018: Results from the 13-Week VENTURE Phase 2 Study of the GLP-1/GIP Co-Agonist VK2735 in Obese Subjects
Poster #018 provided updated results from follow-up visits performed in the previously reported 13-week Phase 2 VENTURE study of VK2735 dosed as a subcutaneous injection. As previously reported, patients receiving weekly doses of VK2735 demonstrated statistically significant reductions in mean body weight after 13 weeks, ranging up to
Change in Body Weight Following 13 Weeks of Once-Weekly Dosing with VK2735 in VENTURE Phase 2 Study
Dose Level1,2 | Placebo (n=34) | VK2735 2.5 mg (n=35) | VK2735 5 mg (n=35) | VK2735 10 mg (n=35) | VK2735 15 mg (n=35) |
Mean baseline body weight (kg)3 | 105.3 kg | 103.1 kg | 98.3 kg | 103.4 kg | 101.1 kg |
Mean change from baseline body weight4,5 | -1.8 kg | -9.2 kg | -10.7 kg | -13.3 kg | -14.6 kg |
Mean percent change from baseline4,5 | -1.7 % | -9.1 % | -10.9 % | -12.9 % | -14.7 % |
Placebo-adjusted mean percent change from baseline4,5 | - | -7.4 % | -9.2 % | -11.3 % | -13.1 % |
p-value vs. placebo5 | - | < 0.0001 | < 0.0001 | < 0.0001 | < 0.0001 |
Percent reporting ≥ | 4 % | 39 % | 62 % | 70 % | 88 % |
p-value vs. placebo6 | - | 0.0036 | 0.0002 | < 0.0001 | < 0.0001 |
Notes: 1) Efficacy population, includes all randomized patients who received at least one dose of study drug and had a valid baseline and post-baseline body weight assessment. 2) Patients treated with VK2735 were titrated to final doses as indicated: 2.5 mg cohort = 2.5 x 13 weeks; 5 mg cohort = 2.5 mg x 3 wks, 5 mg x 10 wks; 10 mg cohort = 2.5 mg x 3 wks, 5 mg x 3 wks, 7.5 mg x 3 wks, 10 mg x 4 wks; 15 mg cohort = 5 mg x 3 wks, 7.5 mg x 3 wks, 10 mg x 3 wks, 15 mg x 4 wks. 3) All enrolled patients were required to have baseline BMI ≥30 kg/m2 or BMI≥27 kg/m2 with at least one weight-related comorbid condition. 4) Least squares mean. 5) Two-sided t test using mixed model for repeated measures. 6) Logistic regression model with treatment as factor and baseline weight as covariate.
The presentation also included newly reported data from a subset of patients assessed for pharmacokinetic (PK) measures. The results showed that all cohorts receiving VK2735 maintained the majority of their weight loss four weeks after receiving the final dose of VK2735 in the study (p<0.0001 vs. baseline and placebo, all cohorts). This includes the lowest dose evaluated, 2.5 mg weekly, for which
Proportion of Weight Loss Maintained, PK Subset (n=75) in VENTURE Phase 2 Study1
VK2735 2.5 mg (n=17) | VK2735 5 mg (n=17) | VK2735 10 mg (n=18) | VK2735 15 mg (n=11) | Combined VK2735 Arms | |
Four Weeks Post Final Dose | 98 % | 92 % | 92 % | 96 % | 94 % |
Seven Weeks Post Final Dose | 91 % | 82 % | 75 % | 87 % | 83 % |
Notes: 1) Pharmacokinetic subset, includes 75 patients (n=63 VK2735; n=12 placebo).
An exploratory analysis of changes in diabetes status was also performed. The results demonstrated that treatment with VK2735 increased the odds of patients with prediabetic status at baseline shifting to normoglycemic (non-diabetic) status over the 13-week treatment period. Similarly, the proportion of patients with normal glycemic status at baseline transitioning to pre-diabetic status favored VK2735, with approximately
Shift in Diabetes Status from Baseline to Week 13 in VENTURE Phase 2 Study
Parameter1 | Placebo | VK2735 2.5 mg | VK2735 5 mg | VK2735 10 mg | VK2735 15 mg | Combined VK2735 Arms |
Pre-diabetic at baseline2 | 14 | 21 | 21 | 16 | 16 | 74 |
Number shifting to normoglycemic at Week 133(%) | 4 (29 %) | 17 (81 %) | 16 (76 %) | 10 (63 %) | 15 (94 %) | 58 (78 %) |
p-value vs. placebo4 | - | 0.0041 | 0.0132 | 0.0813 | 0.0004 | 0.0005 |
Notes: 1) Observed values, no imputation for missing data. 2) Defined as patients with fasting plasma glucose 100 mg/dL to 125 mg/dL or HbA1c
Additionally, as previously reported, the VENTURE study showed VK2735 treatment to have encouraging safety and tolerability following the 13-week treatment period with the majority (
"We are happy to report the updated results from both the VENTURE Phase 2 study and the oral Phase 1 study," said Brian Lian, Ph.D., chief executive officer of Viking. "We believe the VENTURE data demonstrate VK2735's promising efficacy and tolerability profile through 13 weeks of weekly dosing and support our belief that less frequent dosing regimens may provide effective maintenance of weight control. The updated oral Phase 1 study results continue to demonstrate an encouraging tolerability profile and promising signs of clinical activity at doses of up to 100 mg daily. We believe the durable effects observed following 28 days of dosing suggest potential opportunities to introduce lower dose regimens following an initial induction of weight loss. We plan to discuss with the FDA the clinical path forward for injectable VK2735 later this quarter and we expect to initiate a Phase 2 study of the oral tablet formulation of VK2735 by the end of this year."
Details of the Phase 3 injectable and Phase 2 oral study designs will be provided closer to study initiation dates.
About GLP-1 and Dual GLP-1/GIP Agonists
Activation of the glucagon-like peptide 1 (GLP-1) receptor has been shown to decrease glucose, reduce appetite, lower body weight, and improve insulin sensitivity in patients with type 2 diabetes, obesity, or both. Semaglutide is a GLP-1 receptor agonist that has been approved by the
About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders, with three compounds currently in clinical trials. Viking's research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients' lives. Viking's clinical programs include VK2735, a novel dual agonist of the glucagon-like peptide 1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) receptors for the potential treatment of various metabolic disorders. Data from a Phase 1 and a Phase 2 trial evaluating VK2735 (dosed subcutaneously) for metabolic disorders demonstrated an encouraging safety and tolerability profile as well as positive signs of clinical benefit. Concurrently, the company is evaluating an oral formulation of VK2735 in a Phase 1 trial. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a recently completed Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of X-ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo.
For more information about Viking Therapeutics, please visit www.vikingtherapeutics.com.
View original content to download multimedia:https://www.prnewswire.com/news-releases/viking-therapeutics-reports-new-data-from-vk2735-obesity-program-at-obesityweek-2024-302294915.html
SOURCE Viking Therapeutics, Inc.
FAQ
What was the maximum weight loss achieved with oral VK2735 after 28 days?
How much weight loss did VKTX's subcutaneous VK2735 achieve in the VENTURE study?
What percentage of patients achieved ≥10% weight loss in the VENTURE study?