The latest Investing Matters Podcast with Jean Roche, Co-Manager of Schroder UK Mid Cap Investment Trust has just been released. Listen here.
EARLY STAGE ASSET DEVELOPMENT (ESAD)
? INDV-2000 (Selective Orexin 1 [OX1] receptor antagonist):
- Phase 1 Single Ascending Dose (SAD) study has completed and shows encouraging safety and pharmacokinetics in
healthy volunteers. The final Clinical Study Report is expected by the end of Q4-2021.
- The Phase 1 Multiple Ascending Dose (MAD) study is currently planned with the first subject anticipated to be dosed
in Q3-2021.
357p... GLA
https://twitter.com/equity_research/status/1376423311773696004?s=19
Will it rise over £1 when RNS follows?
Here's what they've previously stated...
"In parallel with the regulatory discussions, the Company is assessing the opportunity to fund the US Phase 3 development itself in order to increase the future value of the programme, as well as significantly broadening the pool of potential commercialisation partners."
Promising.
As confidence builds for European approval worth reminding ourselves of the outlook statement in the Feb interims...
Outlook
If approved by the EMA, Chronocort® will provide the Company's commercial cortisol replacement therapy franchise with critical mass, enabling Diurnal to build a strong and profitable European business through penetration of the combined addressable market for the treatment of CAH and paediatric AI, which is estimated by the Company to be worth c.$300 million in Europe alone. In addition, the Group expects an increased contribution from its licensing and distribution partners outside of Europe once regulatory and/or pricing and reimbursement activities for Alkindi® are completed in these territories.
In the US, Diurnal continues to assess the optimal timing for seeking a partner for the commercialisation of Chronocort, which may be following the completion of Phase 3 development itself: if successful, this would be expected to markedly increase the value of the asset.
DITEST™ represents a further valuable addition to Diurnal's growing pipeline of novel endocrinology treatments and, following the fundraising in October 2020, the Company will move forward with the next stage of development in order to maximise the value of this product in the $4.8bn potential market in the US and Europe.
Thanks to those who indulged my question, some really interesting food for thought. Appreciate the replies. SNG is 15% of my portfolio now so want to assess it more than on the first spike.
Really think its true strength would come through in exacerbated patients prior to hospitalisation, which the at home trial well hopefully prove it eventually.
Even if, and don't mean to be glass half empty, the P3 didn't wow, it'd no doubt open up a huge to up opportunity for the longer game: saving lives of COPD patients from myriad viral infections.
Presumably if it was 85% share prices would rise substantially higher off the back of phase two results.
Thanks. That's compelling percentage, just wondering if the change to trial design might impact how we can extrapolate P2 results. I'm excited (impatient) to find out.
Great RNS yesterday, pleased to get the update.
In light of the change in primary end points from osci, how do people think this changes the probability of P3 success?
I may be making this up but thought I'd read finncap adjust chance accordingly thanks to a post on this forum.
Just doing a risk/reward review and the adjustment to endpoints is my only area of internal debate!
As a holder who is most excited by sng001 as the next generation of preventative at home treatment for viral complications in COPD and other vulnerable groups (in which I have high conviction) it's the hospital trials I need to understand more in respect of the change in endpoints... Any thoughts appreciated.