Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Cingal · 4 trials · 3 indications
The change from Baseline in knee pain post-treatment as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal arm to the TH arm, the Cingal arm to the Placebo arm, and the TH arm to the Placebo arm. WOMAC Pain is a validated 100 mm visual analog scale (VAS) from 0 mm = No Pain to 100 mm = Highest Pain Level. A negative value for the change from Baseline indicates improvement in the WOMAC Pain Score, i.e. less pain post-treatment. A larger negative value indicates lower pain levels and a better outcome.
The post treatment Responder Rate at 39 weeks is determined through a calculation defined by the Outcomes Measures for Rheumatic Arthritis Clinical Trials-Osteoarthritis Research Society International (OMERACT-OARSI) Responder Index. The OMERACT-OARSI Responder Index reports the percentage of subjects that met the criteria to be a good responder. The criteria for response are (1) improvement in pain or physical function ≥50% and an absolute change ≥20 mm; or (2) improvement of ≥20% with an absolute change ≥10 mm in at least two of the following three categories: pain, physical function, and patient's global assessment. A higher percentage of subjects responding indicates a better outcome.
The change from baseline in knee pain as measured by the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score comparing the Cingal group to the TH group. The WOMAC Pain Score is a validated visual analog scale from 0 mm = no pain to 100 mm = highest pain level. A negative number for the change from baseline indicates reduction in pain. A greater negative difference from baseline means a better outcome.
The primary outcome measure will compare safety results (all adverse events, whether related to the study injection or not) for Cingal 13-01 and Cingal 13-02.
| Arm | Type | Description |
|---|---|---|
| Cingal | EXPERIMENTAL | Single injection of Cingal: 4 milliliter (mL) dose of 88 mg (22 mg/mL) of cross-linked sodium hyaluronate with 18 mg (4.5 mg/mL) of triamcinolone hexacetonide (TH). Manufactured by Anika Therapeutics. |
| Triamcinolone Hexacetonide (TH) | ACTIVE_COMPARATOR | Single injection of Triamcinolone Hexacetonide (TH): 1 milliliter (mL) dose of 20 mg/ml TH. Manufactured by IntraPharm. |
| Placebo | PLACEBO_COMPARATOR | Single injection of Placebo: 4 milliliter (mL) dose of 0.9% saline. Manufactured by Anika Therapeutics. |
| Monovisc | ACTIVE_COMPARATOR | Monovisc is a device that consists of 88 milligrams of cross-linked HA (hyaluronic acid) in a 4 milliliter (mL) intra-articular injection. |
| Cingal/Cingal | EXPERIMENTAL | Subjects who had received an injection of Cingal in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study. |
| Cingal/Monovisc | EXPERIMENTAL | Subjects who had received an injection of Monovisc in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study. |
| Cingal/Saline | EXPERIMENTAL | Subjects who had received an injection of Saline in the 13-01 study will receive a single 4 milliliter (mL) intra-articular injection of Cingal (88 milligrams Hyaluronic Acid plus 18 milligramsTriamcinolone Hexacetonide) in the index knee in the 13-02 study. |
| Name | Type | Description |
|---|---|---|
| Cingal | DRUG | Single intra-articular injection of Cingal into the knee. |
| Triamcinolone Hexacetonide (TH) | DRUG | Single intra-articular injection of TH into the knee. |
| Placebo | DRUG | Single intra-articular injection Placebo (0.9% Saline) into the knee. |
| Monovisc | DEVICE | Hyaluronic Acid |
| Triamcinolone Hexacetonide | DRUG | Triamcinolone Hexacetonide |
Inclusion Criteria: 1. Subject is 40-75 years old. 2. Body Mass Index (BMI) ≤ 40 kg/m2. 3. Subject has Kellgren-Lawrence (K-L) severity grade II or III in the Index knee as determined by X-Ray. Contralateral knee: K-L severity grade 0, I or II. 4. Subject has had at least two signs and at least two...
Top 5 of 13 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 3 | PHASE3 | Orforglipron, Eloralintide, LY3016859, LY3556050, LY3526318 |
| Pacira Biosciences, Inc. | PCRX | 4 | PHASE3 | ZILRETTA, Enekinragene Inzadenovec, FX201 |
| Novo Nordisk A/S Sponsored ADR Class B | NVO | 1 | PHASE3 | NNC0487-0111 |
| Bioventus, Inc. Class A | BVS | 1 | PHASE2 | PTP-001 |
| Enlivex Ltd. | ENLV | 2 | PHASE1 | Allocetra |
Cingal is used for the relief of knee osteoarthritis pain, including osteoarthritis of the knee. It is an injectable treatment being developed by Anika Therapeutics Inc. for patients with this musculoskeletal condition. Clinical development has focused on pain relief in adults aged 40 years and older with knee osteoarthritis.
Cingal is developed by Anika Therapeutics Inc., which trades under the ticker ANIK. The company is the sponsor of the Cingal clinical program in knee osteoarthritis.
Cingal is in Phase 3 clinical development. It is investigational and has been studied in completed Phase 3 trials for knee osteoarthritis. The program includes three completed trials with a combined enrollment of 1,333 participants.
Cingal has been evaluated in completed Phase 3 trials including NCT04231318, NCT03390036, NCT03191903, and NCT02381652. These studies examined Cingal for knee osteoarthritis pain relief, with NCT04231318 conducted in the United States and the others in Hungary, Poland, and Czechia.
Cingal was studied in randomized, double-blind, active-controlled Phase 3 trials. The trials compared Cingal to triamcinolone hexacetonide for relief of knee osteoarthritis pain, enrolled adults aged 40 years and older, and included follow-up assessments such as at 39 weeks in NCT03390036.