Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03)
Caveolin-1-Scaffolding-Protein-Derived Peptide · 1 trial · 1 indication
Incidence of TEAE by system-organ class and dose group as assessed by the Toxicity Grading Scale for Healthy Adult Volunteers
| Arm | Type | Description |
|---|---|---|
| Placebo | SHAM_COMPARATOR | Matching placebo is a micronized lactose powder administered by inhalation through a dry powder inhaler (DPI) |
| SAD Cohort 1 | EXPERIMENTAL | LTI-03 20 mg delivered qd x 1 day via DPI |
| SAD Cohort 2 | EXPERIMENTAL | LTI-03 40 mg delivered qd x 1 day via DPI |
| SAD Cohort 3 | EXPERIMENTAL | LTI-03 80 mg delivered qd x 1 day via DPI |
| MAD Cohort 1 | EXPERIMENTAL | LTI-03 dose at 20mg once daily x 14 days via DPI |
| MAD Cohort 2 | EXPERIMENTAL | LTI-03 dose at 40mg once daily x 14 days via DPI |
| MAD Cohort 3 | EXPERIMENTAL | LTI-03 dose at 2.5 mg once daily x 14 days via DPI |
| MAD Cohort 4 | EXPERIMENTAL | LTI-03 dose at 5 mg once daily x 14 days via DPI |
| MAD Cohort 5 | EXPERIMENTAL | LTI-03 dose at 5 mg twice daily x 14 days via DPI |
| Name | Type | Description |
|---|---|---|
| Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03) | DRUG | LTI-03, a Caveolin-1 scaffold protein-derived 7-amino acid peptide to be administered as a dry powder by inhalation through a dry powder inhaler. |
| Placebo | DRUG | Matching placebo is micronized lactose powder administered by inhalation through a dry powder inhaler. |
Inclusion Criteria: 1. Non-smoker (no use of tobacco products within 6 months prior to dosing) with a negative urine cotinine test at Screening or Day -1 2. Age of 18-55 years (inclusive) 3. Body mass index (BMI) of 18 - 30.5 kg/m2 (inclusive) 4. Body weight \> 50 kg 5. Willing and able to provide ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |