RMC-035 Drug Asset Due Diligence Report 2026: Clinical, IP, Market, Deals, and Go/No-Go
This RMC-035 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: 16 September 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.
Executive recommendation: CONDITIONAL GO
Decision memo
Advance with milestone-based economics while efficacy durability, safety differentiation, patent scope, and market positioning are validated.
The central underwriting question is whether RMC-035 can convert its Recombinant protein profile and Free radicals x Hemoglobins biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.
1. Asset identity and development status
| Asset | RMC-035 (query alias: RMC-035) |
|---|---|
| Modality / target | Recombinant protein; Free radicals x Hemoglobins; Free radicals inhibitors, Hemoglobins inhibitors |
| Highest global status | Phase 2 |
| Originator | Guard Therapeutics International AB |
| Active developers | Guard Therapeutics International AB |
The MCP disease footprint includes Acute Kidney Injury, Renal transplant rejection, Sepsis. 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 |
|---|---|---|---|---|
| NCT06475274 | Phase 2 | Completed | 170 | Primary endpoint not disclosed in English source |
| NCT05126303 | Phase 2 | Terminated | 177 | Primary endpoint not disclosed in English source |
| NCT04829916 | Phase 1 | Completed | 13 | Primary endpoint not disclosed in English source |
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
Efficacy and safety of therapeutic alpha-1-microglobulin RMC-035 in reducing kidney injury after cardiac surgery: a multicentre, randomised, double-blind, parallel group, phase 2a trial
Phase 2; n=177; evaluation: Negative. Reported fields: AKI = 50.6 % ; AKI = 39.8 %
A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Adaptive, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
Phase 2; n=177; evaluation: Not stated in English source. Reported fields: Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria = 50.6 % ; Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria = 39.8 %
A Phase 1b, Randomised, Double-Blind, Parallel Treatment Group Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RMC-035 in Subjects Undergoing Non-Emergent On-Pump Coronary Artery Bypass Graft and/or Valve Surgery
Phase 1; n=13; evaluation: Not stated in English source. Reported fields: Subject with at least one AE = 6 Pts ; Subject with at least one AE = 1 Pts
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
RMC-035 addresses Acute Kidney Injury, Renal transplant rejection, Sepsis. Commercial attractiveness rests on addressable 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 MCP screen returned matched transaction record(s) under the scope “target-level comparable: Free radicals x Hemoglobins.” Partner activity is a market-validation signal, but it does not establish net present value.
5. Transaction precedent and economics
Transaction-scope note: No direct asset-specific transaction was returned. The table below shows target-level comparable: Free radicals x Hemoglobins records as comparable precedents only.
| Date | Transaction | Phase at deal | Disclosed economics |
|---|---|---|---|
| No matched asset or comparable transaction returned. | |||
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 “Use of alpha-1-microglobulin for protection of bone marrow cells”. The milestone feed surfaced a patent-application signal described as “Novel alpha-1-microglobulin derived proteins and their use”. The milestone feed surfaced a patent-application signal described as “Alpha-1-microglobulin for use in the protection of kidneys in radionuclide therapy”.
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.
7. Principal risks and diligence gates
- Clinical differentiation versus current standards and pipeline competitors
- Safety, dose optimization, and long-term tolerability
- Patent scope, territorial rights, manufacturing, and commercial positioning
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
CONDITIONAL GO
Advance with milestone-based economics while efficacy durability, safety differentiation, patent scope, and market positioning are validated.
Required pre-signing gates: reproduce key efficacy analyses; complete an indication-specific safety review; run a full patent-family and freedom-to-operate search; model risk-adjusted economics by territory; and reconcile all rights, sublicenses and encumbrances.
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Data provenance: PatSnap Drug & Asset MCP, Clinical Trials MCP, and Company & Deal Intelligence MCP; accessed 2026-09-16. Counts and status fields may change as source records update.
