Nomacopan Drug Asset Due Diligence Report 2026

This Nomacopan Drug Asset Due Diligence Report was built with PatSnap Life Sciences MCP workflows. Drug & Asset MCP establishes identity, ownership and stage; Clinical Trials MCP checks design, endpoints and readouts; Company & Deal Intelligence MCP reconstructs transaction precedent. Explore the MCP servers used in this report.

Decision date: 15 July 2026. Currency fields are presented in US$ millions as returned by the deal dataset. This is a screening memorandum, not legal, medical, patent or investment advice.

Preclinical

Highest phase

Registered trials

Result records

Matched deals

Executive recommendation: HOLD / OPTION

Decision memo

Preserve optionality until clinical differentiation, transaction economics, and freedom-to-operate are sufficiently de-risked.

The central underwriting question is whether Nomacopan can convert its Recombinant protein profile and C5 biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Nomacopan (query alias: nomacopan)
Modality / target	Recombinant protein; C5; C5 inhibitors, LTB4 inhibitors
Highest global status	Preclinical
Originator	Evolutec Ltd.
Active developers	Akari Therapeutics Plc

The MCP disease footprint includes dry age-related macular degeneration, Conjunctival Diseases, Geographic Atrophy. The highest-phase flag is a useful orientation point, but the licensing case depends on indication-level evidence and rights, not the global label alone.

2. Clinical program: design and endpoint audit

Registry	Phase	Status	Enrollment	Lead primary endpoint
NCT04784455	Phase 3	Terminated	10	Number of Participants NOT Requiring a Red Blood Bell Transfusion (Transfusion Independence) for 28 Days or More OR Number of Participants With a Urine Protein Creatinine Ratio Value of ≤ 2 mg/mg Maintained for 28 Days or More.
SLCTR/2020/005	Phase 3	Terminated	5	Not disclosed
NCT04035733	Phase 2	Completed	9	Safety parameter

The trial set should be diligenced for randomization, comparator relevance, endpoint hierarchy, analysis population, multiplicity, geographic mix and readout timing. For early-stage studies, safety and dose selection can be as decision-critical as response rate.

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3. Clinical readouts: what is known

Multicentre Study of Nomacopan (rVA576) in Paediatric Haematopoietic Stem-Cell Transplant Associated Thrombotic Microangiopathy

Phase 3; n=10; evaluation: not stated. Reported fields: -; -; -

CONSENT II: Coversin in Paroxysmal Nocturnal Hemoglobinuria (PNH) in Patients With Resistance to Eculizumab Due to Complement C5 Polymorphisms

Phase 2; n=1; evaluation: not stated. Reported fields: -; Screening = 2913 U/L ; -

CONSERVE: rVA576 (Coversin) Long Term Safety and Efficacy Surveillance Study

Phase 3; n=15; evaluation: not stated. Reported fields: -; -; -

These fields are structured evidence signals, not a substitute for statistical review. The next diligence pass should reconcile denominators, confidence intervals, follow-up, censoring, dose cohorts and treatment-emergent toxicity against the original abstract, registry and protocol.

4. Market and competitive position

Nomacopan addresses dry age-related macular degeneration, Conjunctival Diseases, Geographic Atrophy. Commercial attractiveness rests on addressable biomarker-positive patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Recombinant protein—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The strongest market-validation signal in this screen is partner behavior: 1 matched transaction record(s) indicate that sophisticated counterparties have assigned strategic value to the asset or its rights. That does not establish net present value; probability of success, remaining R&D spend, royalties, cost sharing and territorial scope still need modeling.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2021-03-04	Akari Therapeutics Announces a Cooperative Research and Development Agreement (CRADA) with the U.S. Army Institute of Surgical Research (USAISR) for Nomacopan in Trauma	Phase 3	Financial terms not disclosed

Headline values are not directly comparable. Diligence should normalize upfront cash, equity, development and sales milestones, tiered royalties, opt-in mechanics, cost sharing, change-of-control clauses and geography.

6. IP and freedom-to-operate screen

The milestone feed surfaced a patent-application signal described as “Methods of removing impurities during recombinant production of nomacopan”. The milestone feed surfaced a patent-application signal described as “Nomacopan-pas fusion proteins”.

The claim chart should separately test composition or sequence coverage, formulation and dosing, indication and biomarker claims, combinations, manufacturing know-how, prosecution history, term extensions and third-party blocking rights. Confirm that licensed patents, data and know-how track every granted territory and field.

7. Principal risks and diligence gates

Class crowding and differentiation versus other PD-(L)1/VEGF agents
Immune and anti-angiogenic safety, including bleeding and cardiovascular risk
Biomarker strategy, indication selection, and head-to-head endpoint execution

Cross-functional diligence should also test CMC comparability, supply chain, pharmacovigilance, regulatory correspondence, data integrity, investigator concentration, partner obligations and change-of-control restrictions.

8. Final go/no-go memorandum

HOLD / OPTION