Miridesap Drug Asset Due Diligence Report 2026

This Miridesap 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: 18 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.

Phase 2

Highest phase

Registered trials

Result records

Matched deals

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 Miridesap can convert its Small molecule drug profile and APCS biology into clinically meaningful differentiation while preserving an investable safety, IP and commercial position.

1. Asset identity and development status

Asset	Miridesap (query alias: Miridesap)
Modality / target	Small molecule drug; APCS; APCS inhibitors
Highest global status	Phase 2
Originator	F. Hoffmann-La Roche Ltd.
Active developers	F. Hoffmann-La Roche Ltd.

The MCP disease footprint includes Amyloidosis. 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
NCT03417830	Phase 1	Terminated	2	Primary endpoint not disclosed in English source
NCT03044353	Phase 2	Terminated	7	Primary endpoint not disclosed in English source
NCT02953808	Phase 1	Completed	18	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

An observational, non-interventional study for the follow-up of patients with amyloidosis who received miridesap followed by dezamizumab in a phase 1 study

Phase 1; n=23; evaluation: Positive. Reported fields: ADR = 73.9 %

A Multiple Treatment Session, Open Label Phase 2 Clinical Study of GSK2398852 Administered Following and Together With GSK2315698 in Cohorts of Patients With Cardiac Amyloidosis

Phase 2; n=7; evaluation: Not stated in English source. Reported fields: Session 2, Day 24, n=6,0(Mean) = 2.505 g ; 8 Weeks Follow up, n=6,1(Mean) = -32.420 g

An Adaptive, Open-Label Study to Evaluate the Biodistribution of 89Zirconium-labelled GSK2398852 in the Heart and Other Organs of Patients With Transthyretin Cardiomyopathy (ATTR-CM) Using Positron Emission Tomography (PET) Imaging

Phase 1; n=2; evaluation: Not stated in English source. Reported fields: Session1:Blood pool left atrium,Day4,n=2(Mean) = 2.995 Grams per milliliter ; Session2:Blood pool left atrium,Day3(Mean) = 10.290 Grams per milliliter

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

Miridesap addresses Amyloidosis. Commercial attractiveness rests on addressable patients, treatment-line placement, duration, administration burden, pricing and displacement of entrenched standards. The modality—Small molecule drug—must demonstrate a benefit large enough to offset class-specific safety and operational costs.

The MCP screen returned 2 matched transaction record(s) under the scope “asset-specific.” Partner activity is a market-validation signal, but it does not establish net present value.

5. Transaction precedent and economics

Date	Transaction	Phase at deal	Disclosed economics
2009-03-11	UCL and GSK join forces to develop combined small molecule-antibody treatment for rare disease	Preclinical	Financial terms not disclosed
2009-01-27	Pentraxin Therapeutics Ltd acquires full rights to develop a drug treatment in systemic amyloidosis from Roche	Not disclosed	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 “Pharmaceutical Compositions and Methods Comprising A Combination of a Benzoxazole Transthyretin Stabilizer and an Additional Therapeutic Agent”. The milestone feed surfaced a patent-application signal described as “Combination therapy”. The milestone feed surfaced a patent-application signal described as “Antigen binding 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.

7. Principal risks and diligence gates

Therapeutic index and off-target toxicity
Resistance biology and biomarker-defined patient selection
Differentiation from established and emerging standards

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