Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2491

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1
Chunk 2491
---
 potentially use in the design of future clinical development work. Additionally, we believe
OCF-203’s safety observations in animal studies may be further supported by past published literature which estimates that 6% of
humans do not produce Chit1 and, though they may be more susceptible to infection by chitin-containing parasites, this deficiency may
provide greater longevity and reduced age-related disease burden as compared to people who produce Chit1 normally. Taken together, these
findings suggest that therapies that focus on inhibiting Chit1 may be well tolerated in patients. This is of import to IPF and HPS given
that there are no currently approved drug therapies for HPS, and the currently approved therapies for IPF, pirfenidone and nintedanib,
both carry a significant risk of severe side effects, as described previously.

27

Fibrosis
Programs Clinical Development Plan

We
have identified opportunities in the structure of OCF-203 that we believe may be able to improve the expected risk/benefit ratio for
patients. We intended to embark on a limited structure-activity-relationship, or SAR, study and planned to begin IND enabling studies
in 2023. We plan to submit our IND application to the FDA within 18 months of raising sufficient capital to fund such IND projects.

Clinical
Development

Clinical
development of OCF-203 is expected to initiate with a single Phase 1/2 clinical trial in IPF that we plan will be followed by later stage
clinical development for IPF and HPS in parallel. We intend to conduct a Phase 1/2 SAD/MAD trial in patients with IPF that is modeled
after the Phase 2 portion of the Galapagos PINTA trial (NCT03725852). Our Phase 1/2 clinical trial is expected to be designed to provide
human proof of concept data demonstrating the cessation of fibrosis progression, which would allow for the initiation of Phase 3 clinical
trials in both IPF and HPS. The Phase 3 clinical trial of OCF-203 for the prevention of fibrotic progression in IPF will likely be modeled
after the Genentech ASCEND trial (NCT01366209), while the Phase 3 clinical trial of OCF-203 for the prevention of fibrotic progression
in HPS will likely be modeled after the National Human Genome Research Institute, or NHGRI, trial in HPS patients (NCT00001596).