- Australian biopharma player CLINUVEL PHARMACEUTICALS announced that the first patient suffering from XP-C (xeroderma pigmentosum) was administered SCENESSE® (afamelanotide 16 mg).
- After confirmation of the safety of SCENESSE® in the Special Access Program, the DNA Repair Program will continue with an open-label Phase 2 trial (CUV150) and a control study (CUV151).
- Regenerative medicine company Mesoblast Limited disclosed that its lead candidate remestemcel-L was announced as the winner of the 2020 Fierce Innovation Awards for Biotech Innovation.
- The award highlight’s the Company’s leadership in bringing innovation to the cell therapy industry.
ASX 200 listed healthcare companies CLINUVEL PHARMACEUTICALS LTD (ASX:CUV) and Mesoblast Limited (ASX:MSB) garnered attention from market participants today following some key announcements. Both the ASX200 stocks contributed to the rise in the Health Care sector index.
The benchmark index, S&P/ASX 200, ended today’s session at 5,894.8 points, broadly in line with the previous close (-0.08%). However, S&P/ASX 200 Health Care sector gained 1.16% to close the session at 42,177.7 points.
Let us discuss the latest announcement of the two healthcare companies CLINUVEL & Mesoblast on the ASX.
The First Patient With Rare Disease XP-C Receives CLINUVEL’s SCENESSE®
Global biopharmaceutical company CLINUVEL PHARMACEUTICALS LTD focusses on developing as well as delivering treatments for various severe genetic, skin, and systemic conditions. CLINUVEL is headquartered in Melbourne and has its operations in the US, EU, and Singapore. SCENESSE® (afamelanotide 16 mg) is the lead compound of the Company.
SCENESSE® is approved in the European Union as an orphan drug for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).
On 15 September 2020, CLINUVEL PHARMACEUTICALS revealed that the first patient suffering from XP-C (xeroderma pigmentosum) had been administered SCENESSE® (afamelanotide 16 mg). The first patient shall be tested under the Special Access Program (SAP), and it is a part of the DNA Repair Program of CLINUVEL.
Following the announcement, CUV share price moved north, closing 3.989% higher at A$22.160. The Company has a market capitalisation of almost A$1.05 billion.
The Company is evaluating SCENESSE® in a staged clinical program to verify the ability of the drug to assist repair DNA damage of skin induced by UV. Currently, SCENESSE® is prescribed as the standard of care for EPP in Europe and the US.
After confirmation of the safety of the drug product in the Special Access Program, the DNA Repair Program shall continue with an open-label Phase 2 trial (CUV150) and a control study (CUV151).
In CUV150 and CUV151 studies, clinical as well as histological (skin biopsies) evaluation of SCENESSE® will be undertaken.
The CUV150 group will include six XP-C patients, and control study CUV151 will enrol ten healthy volunteers. CLINUVEL disclosed that sponsored studies CUV150 and CUV151 details should be released in the forthcoming weeks.
On 10 September 2020, the Company disclosed its innovative SCENESSE® DNA Repair Program. The program intends to confirm that intervention with SCENESSE® causes elimination of DNA damage (photoproducts) along with DNA regeneration.
Dr Dennis Wright, Chief Scientific Officer of CLINUVEL, stated-
Mesoblast’s Remestemcel-L Wins at Fierce Innovation Awards
Regenerative medicine player Mesoblast Limited is a world leader in developing off-the-shelf medicines. The Company operates in the United States, Singapore, and Australia. Mesoblast has an extensive worldwide IP portfolio with protection in all major markets extending through to at least 2040.
Mesoblast, today, updated the market that remestemcel-L had been selected as the winner of the 2020 Fierce Innovation Awards for Biotech Innovation.
Post this significant announcement, the share price of MSB rose by 3.448% to close the market at A$4.800. The market capitalisation of MSB stood at A$2.72 billion with nearly 586.59 million shares trading on the ASX.
Mesoblast’s remestemcel-L, which has lately been assessed against acute respiratory distress syndrome (ARDS) in COVID-19 patients, secured the major Fierce Biotech Innovation of the Year award. The innovation award is peer-reviewed from the FiercePharma and FierceBiotech publisher.
Dr Silviu Itescu, Chief Executive of Mesoblast, commented-
Remestemcel-L is under priority assessment by the US FDA (Food and Drug Administration) for SR-aGVHD in children. If the FDA approves it, the launch of the product is anticipated in 2020 in the US. The FDA has agreed a PDUFA (Prescription Drug User Fee Act) action date of 30 September 2020.
Remestemcel-L for treatment of ARDS due to COVID-19 infection
Remestemcel-L is being evaluated in Phase 3 clinical trial in up to 300 adults with moderate to severe ARDS who are ventilator-dependent.
On 3 September 2020, Mesoblast disclosed that the independent DSMB (Data Safety Monitoring Board) advised resuming the Phase 3 study of remestemcel-L in patients with moderate to serious ARDS due to COVID-19. The decision by DSMB follows the completion of the first interim analysis of the Phase 3 trial.
The Company stated that the evaluation was done on the first 30% of the total target of randomised patients, with the DSMB examining the primary endpoint of the clinical trial which is all-cause mortality within 30 days of randomisation.
Mesoblast stated that the Phase 3 clinical trial recruitment is estimated to complete during Q4 CY20.
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