Delving into the Latest Updates on Gen Ilaç ve Saglik Ürünleri Sanayi ve Ticaret AS with Synapse

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Immune System Diseases

Skin and Musculoskeletal Diseases

Small molecule drug

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A glimpse into the focused therapeutic areas

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Disease Domain	Count

Immune System Diseases	1

Top 5 Drug Type	Count

Small molecule drug	1

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COX x GR x RARα x RARβ2 x RARγ	1

This Phase II study was designed as a multicenter, randomized, double-blind, placebo-controlled and 3-parallel arm, to assess clinical efficacy, safety, and tolerability of GN-037 versus clobetasol 17-propionate and placebo in patients diagnosed with mild to moderate plaque psoriasis at least 6 months ago

Start Date07 Dec 2022

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Gen Ilaç ve Saglik Ürünleri Sanayi ve Ticaret AS

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100 Clinical Results associated with Gen Ilaç ve Saglik Ürünleri Sanayi ve Ticaret AS

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0 Patents (Medical) associated with Gen Ilaç ve Saglik Ürünleri Sanayi ve Ticaret AS

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Literatures (Medical) associated with Gen Ilaç ve Saglik Ürünleri Sanayi ve Ticaret AS

01 Jun 2024·Toxicology Reports

Safety, tolerability and toxicokinetics of the novel mitochondrial drug SUL-138 administered orally to rat and minipig

Article

Author: van der Graaf, Adrianus C ; Swart, Daniël H ; Ulu, Nadir ; Touw, Daan J ; de Haan, Martin ; Adel, Sovan ; Stevens, Jasper ; Henning, Rob H ; Krenning, Guido

Noncommunicable Chronic Diseases (NCD) are a socioeconomic burden and considered one of the major health challenges for coming decades. Mitochondrial dysfunction has been implicated mechanistically in their pathophysiology. Therefore, targeting mitochondria holds great promise to improve clinical outcomes in NCDs. SUL-138, an orally bioavailable small molecule efficacious from 0.5 mg/kg, improves mitochondrial function during disease in several preclinical animal models. As preparation for a First-in-Human (FIH) trial, SUL-138 was investigated in 30-day GLP repeated dose toxicity studies in rat and minipig, selected based on their comparability with human metabolism, to determine toxicokinetics, potential toxicity and its reversibility. Rats were allocated to either vehicle, 27, 136 or 682 mg/kg SUL-138 dose groups and minipigs were allocated to either vehicle, 16, 82 or 409 mg/kg. Treatment occurred orally for 30 days followed by a recovery period of 14 days. During these studies clinical observations, toxicokinetic, clinical pathology, necropsy and histopathology evaluations were performed. There was significant systemic exposure to SUL-138 and toxicokinetics was characterized by a rapid absorption and elimination. In the rat, toxicokinetics was dose-proportional and AUC_0-tlast ratios in both species indicated that SUL-138 does not accumulate in vivo. No treatment-related adverse effects were observed for dose levels up to 136 and 82 mg/kg/day in rat and minipig respectively. In conclusion, these preclinical studies demonstrate that SUL-138 is well tolerated after repeated administration in rat and minipig, with NOAELs of 136 and 82 mg/kg/day, respectively.

01 Jul 2023·Dermatology and Therapy

Safety and Efficacy of a Novel Combination Cream (GN-037) in Healthy Volunteers and Patients with Plaque Psoriasis: A Phase 1 Trial

Article

Author: Cinar, Salih L ; Mehmetoglu Al, Ayca ; Karasulu, Hatice Y ; Sezer, Zafer ; Altug, Sedat ; Kozlu, Serhat ; Inal, Ahmet ; Ulu, Nadir ; Mazicioglu, Mustafa M ; Diril, Mine

INTRODUCTIONPsoriasis is a common skin disorder associated with physical and psychological burdens. Visible disfiguration can trigger a negative reaction which can cause much of the readily measurable psychological burden of the disease. Although many biological treatments provide some success in the initial clearance of lesions, there is a dispute about the long-term maintenance of the disease, as no current biological treatment has been shown to be curative. Topical therapies are still the most widely used agents as first-line and maintenance treatment for psoriasis. The present study aimed to investigate the safety, tolerability, and, to some extent, efficacy of GN-037 cream in patients with psoriasis and healthy volunteers.METHODSA randomized, double-blind, single-center, placebo-controlled phase 1 clinical study was conducted to evaluate the safety, tolerability, and clinical efficacy of GN-037 cream topically applied twice daily for 2 weeks in healthy subjects (n = 12) and patients (n = 6) diagnosed with plaque-type psoriasis. Six healthy subjects received placebo. Patients with plaque psoriasis were evaluated by a dermatologist, and Physician Global Assessment (PGA) score was required to be ≥ 3 (moderate psoriasis) at screening.RESULTSA total of 31 adverse events (AEs) occurred in 13 participants during the study: 9 AEs in healthy subjects receiving GN-037 cream, 3 AEs in healthy subjects receiving placebo, and 1 AE in one psoriatic patient. The most frequently reported AEs were reactions at the application site, including erythema, exfoliation, pruritus, and burning sensation. During the baseline evaluation, one patient had a PGA score of 3 (moderate) and five patients had a PGA score of 4 (severe). On day 14, in treatment, four patients experienced second grade and two patients third grade improvements compared with baseline, indicating a shift of patients from moderate and severe disease to mild disease and to almost clear (score 2 or 1). There were slight increases in plasma tumor necrosis factor (TNF)-α, interleukin-17 (IL-17) and interleukin-23 (IL-23) levels in both healthy volunteers and patients throughout the study, as compared with baseline.CONCLUSIONThe results of this phase 1 trial conducted in 18 healthy volunteers and 6 patients with plaque psoriasis demonstrated a favorable safety and tolerability profile for GN-037; therefore, further clinical development of GN-037 in a phase 2 clinical trial has been initiated in patients with mild to moderate plaque psoriasis (NCT05706870).TRIAL REGISTRATION NUMBERNCT05428202.

100 Deals associated with Gen Ilaç ve Saglik Ürünleri Sanayi ve Ticaret AS

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100 Translational Medicine associated with Gen Ilaç ve Saglik Ürünleri Sanayi ve Ticaret AS

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Pipeline

Pipeline Snapshot as of 07 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

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