Redx Pharma

Rezurock approval has positive read across for Redx

Lighthouse | 19 July 2021

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  • The FDA has approved Kadmon’s Rezurock (belumosodil) for chronic graft-versus-host disease (GVHD). The approval is six weeks ahead of the revised PDUFA date of 30 August and marks the first authorisation of a ROCK2 inhibitor globally. Rezurock is a 200mg once daily oral treatment for cGVHD, a common and often fatal complication following hematopoietic stem cell transplantation, after failure of at least two prior lines of systemic therapy.
  • Rezurock’s approval is based on impressive clinical results that demonstrated efficacy and, importantly, is supported by additional safety data (the reason underlying the original delay as FDA reviewed the new data). Rezurock is also in Phase II trials for the treatment of systemic sclerosis (SSc), where it has Orphan Drug Designation. Kadmon is developing a second ROCK inhibitor, KD045, with positive preclinical results in lung, kidney, and liver fibrosis models; but this is a pan-ROCK inhibitor, raising concerns about possible hypotension due to inhibiting ROCK1 and ROCK2 simultaneously.
  • Redx Pharma is one of only two other companies with a ROCK inhibitor in clinical development. RXC007 is a particularly promising programme that offers the prospect of being best-in-class. It is a novel and highly specific small molecule that selectively targets the ROCK2 (Rho Associated Coiled-Coil Containing Protein Kinase 2) receptor. The ROCK pathways modulate inflammatory responses and fibrotic processes and play a key role in many immune and fibrotic diseases.
  • RXC007 is completing its first Phase I study, with results expected in H122. These data will guide the dosing and structure of the Phase II programme. Future development will initially be for idiopathic pulmonary fibrosis (IPF), a progressive lung condition with a notably poor prognosis. This will likely be followed by broader fibrotic indications, potentially including liver fibrotic indications such as Non-Alcoholic Steatohepatitis (NASH).

Trinity Delta view: Redx Pharma has established a notable reputation for its medicinal chemistry expertise which it is exploiting through a combination of in-house developed programmes and partnerships (with AstraZeneca and Jazz Pharmaceuticals). The lead programme is RXC004, a porcupine inhibitor poised to enter Phase II studies in a selection of genetically selected solid tumours. RXC007 is the second in-house compound and Rezurock’s approval creates a clear regulatory pathway and, in our view, materially de-risks RXC007’s development process. Our rNPV model, employing conservative assumptions, generates a £350.7m valuation, equivalent to 128p/share (86p fully diluted).


19 July 2021

Market Cap£158m
Primary exchangeAIM London
Company CodeREDX
Corporate clientYes

Company description

Redx Pharma specialises in the discovery and early clinical development of small molecule therapeutics, with an emphasis on oncology and fibrotic disease. Typically, these are progressed through proof-of-concept studies and then partnered for further development. The strategy has been validated by several collaborations.


Lala Gregorek
+44 (0) 20 3637 5043

Franc Gregori
+44 (0) 20 3637 5041


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