A considered view28 Jun 2019 12:10
The company's strategy which combines clinical, regulatory and commercial activities is to bring Lupuzor to the market. To this end the company 'continues to engage with potential partners as well as consulting with regulatory advisors on potential pathways to market.'
Clinical progress has been through identification of sub groups with higher responder rates in the PIII trial, most notably patients in the European cohort with elevated levels of anti dsDNA positive auto antibodies, a bio marker of disease severity. Of 79 patients in this sub group, responders rates were 71.1% on active and 48.8% on placebo, clinical impact 22.3%, p value 0.0218. Of 43 patients in the sub group with low complement the responders rates were 68.4% and 43.5% respectively, clinical impact 24.9% and for those 34 patients anti dsDNA positive and low complement 71.4% and 40% respectively a clinical impact of 31.4%. In the Life Sciences Division report, 'Disease Modification in a spectrum of severity for Lupus Patients,' Navid Malik concludes, due to the outstanding efficacy results seen in the recent PIII study including only anti dsDNA positive patients should generate a positive outcome for the next Phase III study. Robert Zimmer noted that remission observed in the PIII trial was unprecedented, the remission rate of 32% in the open label study at the final visit compared to the initial visit is extraordinary. Regulatory progress: the above analyses have informed an optimal design for a second PIII trial as the second leg of the existing Special Protocol Assessment as follows: patient recruitment, patients with anti dsDNA positive status / biomarker for severity and standard of care with steroid dosage regime starting high and reducing throughout the study. A new study protocol is under discussion in a regulatory policy environment that is open to reviewing the failed Lupus clinical trial regime. Commercial progress, the clinical and regulatory developments present an attractive package for potential commercial partners. The structure of a deal could be based on an licence or a special purpose vehicle (which would allow the company to invest in part of the second trial costs and attract a higher percentage royalty). With a clear target patient group, supportive clinical trial design, small wonder Lanstead is confident of a deal. Along the way, the company will realise the currently stranded £2m investment in Incanthera, unlock the value of Elro and Ureka and subject to a rising share price maximise funding from the recent Lanstead deal.