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...
Cingal is an investigational small molecule being developed for knee osteoarthritis, including osteoarthritis of the knee. It is intended to provide relief for patients with this condition. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Cingal is being developed by Anika Therapeutics Inc., a company traded on the NASDAQ under the ticker symbol ANIK. The company is conducting Phase 3 clinical trials to evaluate the drug's safety and efficacy for knee osteoarthritis.
Cingal is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA or other regulatory agencies. Multiple Phase 3 trials have been completed to assess its use for knee osteoarthritis.
Cingal has been studied in several Phase 3 clinical trials, including NCT02381652, NCT03191903, NCT03390036, and NCT04231318. These trials evaluated repeat injections and comparisons to triamcinolone hexacetonide for knee osteoarthritis relief. All trials are completed.
Cingal is a small molecule designed to treat knee osteoarthritis. Its specific molecular target has not been disclosed in available information, so its exact mechanism of action is not detailed here.