CLINUVEL refines injectable peptide candidate after positive pre-clinical results
CLINUVEL Pharmaceuticals (ASX: CUV | Nasdaq: CUVL) has identified a lead candidate formulation from its VLRX-L controlled-release liquid injectable peptide platform following pre-clinical study results.
One of four candidate formulations demonstrated a superior release profile over the targeted peptide delivery window, with lower peak plasma levels and drug detected across the delivery period.
The selected candidate is now being refined at CLINUVEL’s Singaporean Research, Development and Innovation (RD&I) Centre, VALLAURIX, with a further pre-clinical study scheduled for early Q1 2027, pending final results, and manufacturing scale-up currently being scoped.
When big ASX news breaks, our subscribers know first
What the VLRX-L pre-clinical data showed
Of the four candidate VLRX-L formulations tested in pre-clinical models, one demonstrated the strongest controlled-release performance. The study sought to confirm earlier in vitro results in pre-clinical models, an objective the company stated has now been demonstrated.
The selected candidate showed the following characteristics:
-
A superior release profile over the targeted peptide delivery window
-
Lower peak plasma levels
-
Drug detected across the intended delivery period
Dr Dennis Wright, Chief Scientific Officer
“At the current stage of development with VLRX-L we were looking for an indication that our candidate formulations could control the release of a peptide in a pre-clinical model,” said Dr Dennis Wright, CLINUVEL’s Chief Scientific Officer. “This has now been demonstrated.”
Understanding controlled-release peptide delivery
The VLRX-L platform aims to deliver peptide drugs in flexible, controlled-release doses. This would allow for greater individualisation of patient treatment, adjusting the amount and timing of a dose to suit each patient.
A practical benefit, as stated by the company, is the ability to titrate doses or adjust for specific patient populations, such as adolescent or paediatric patients. CLINUVEL’s initial focus for the platform is on melanocortins, peptides which bind to the body’s five melanocortin receptors and are known to affect:
-
Melanogenesis
-
Inflammation
-
Libido
-
Other functions
A flexible-dosing platform could broaden CLINUVEL’s melanocortin franchise beyond its existing approved therapy into new patient populations, though this remains an early-stage development objective.
Next steps and platform outlook
CLINUVEL has outlined a forward roadmap for the platform based on the disclosed pre-clinical results:
-
Refinement of the lead candidate formulation at the VALLAURIX RD&I Centre in Singapore, currently ongoing
-
A further pre-clinical study scheduled for early Q1 2027, pending final results
-
Manufacturing scale-up currently being scoped
Dr Dennis Wright, Chief Scientific Officer
“We now have clearer pathways that are being pursued for a range of peptides and we are working towards optimising these formulations. It is innovative work requiring much of our technical team, and we are encouraged by the data that have been generated to date,” Dr Wright added.
VLRX-L sits within CLINUVEL’s broader melanocortin-focused portfolio. The company’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Canada, Israel and Australia for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
The Phase III CUV107 vitiligo trial, which secured final EMA scientific advice following over 12 months of regulatory dialogue, is scheduled to enrol 300 adults and adolescents comparing SCENESSE plus NB-UVB phototherapy against NB-UVB monotherapy, representing the regulatory pathway being pursued in parallel with earlier-stage platform work.
Platform snapshot
| Element | Detail | Status |
|---|---|---|
| Platform | VLRX-L controlled-release liquid injectable peptide | In development |
| Candidates tested | 4 formulations | 1 selected |
| Next pre-clinical study | Q1 2027 | Scheduled (pending results) |
| Manufacturing | Scale-up | Being scoped |
| Location | VALLAURIX RD&I Centre, Singapore | Active |
Don’t Miss the Next Healthcare Breakthrough on ASX
Big News Blast delivers FREE breaking ASX healthcare news directly to your inbox within minutes of release, complete with in-depth analysis. Join 20,000+ subscribers already staying ahead of the market. Click the “Free Alerts” button at StockWire X to receive the next market-moving announcement the moment it drops.