Company: OCEA
Filing Date: 2025-04-08
Form Type: 10-K
Source: 0001641172-25-003155
Chunk: 2086

Company: Ocean Biomedical, Inc.
Filing Date: 2025-04-08
Form: 10-K
Item: Item 1A
Chunk 2086
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 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). Both
the Genentech and NHGRI trials were evaluating pirfenidone. We intend to seek orphan drug designation for OCF-203 in HPS.

Infectious
Diseases Product Candidates for Malaria

    ●
    ODA-570
    Vaccine for the Prevention of P. falciparum Infection

    ●
    ODA-611
    anti-PfGARP mAb for the Treatment of Symptomatic P. falciparum Infection

    ●
    ODA-579
    anti-PfGARP Small Molecule for the Treatment of Symptomatic P. falciparum Infection

Infectious
diseases, caused by infection with viruses, bacteria, fungi or parasites