The graph and article was from April of this year, and given the snail like speed of clinical trials, I cannot imagine a whole lot is different now.
Good odds of things in stage 3/4 coming to market. Stage 1/2 studies have a much higher likelihood of not meeting the results needed to proceed further (not sure the exact odds of fallout, but it's gotta be close to 50/50 odds or worse). Beating placebo isn't easy, lots of great-on-paper ideas fail that test.
But yeah do be careful of the sensational news articles around study meds. Anything early on like that, is trying first-and-foremost to encourage investment dollars and they tend to be a bit sensational in the press releases to get the money they need to continue. Sometimes they get picked up by major media outlets who, in all of their lack of research, amp it up a little more lol.
But in regards to LT-02, here's what the article linked above has to say about
One such therapy is LT-02 (Nestlé Health Science), which demonstrated promising early results in clinical trials, including a phase II trial for UC patients refractory to mesalazine.Display footnote number:22 This was a double-blind, randomized, placebo-controlled superiority study that analyzed 156 patients with UC and a deficient response to mesalazine therapy. Co-medication with 5-ASA, systemic steroids, azathioprine, and 6-mercaptopurine was allowed if specific dosing and duration criteria were met. Patients receiving rectally applied aminosalicylates or steroids, or oral topically acting steroids were excluded. The primary endpoint was change in the simple clinical colitis activity index (SCCAI). This study compared placebo to LT-02 doses of 0.8g, 1.6g, and 3.2g, and demonstrated a SCCAI score decrease of 33.3% in the placebo group vs. 44.3% in the 0.8g, 40.7% in the 1.6g, and 51.7% in the 3.2g doses (p>0.05, p>0.05, and p=0.030 respectively). Remission for placebo vs. 3.2g was 15% vs. 31.4% (p=0.089). Interestingly, despite a modest clinical improvement in patients receiving LT-02 vs. placebo, histologic remission was achieved in 20% of placebo patients compared to 40.5% LT-02 patients (p=0.016). Patients achieved mucosal healing in 32.5% for placebo vs. 47.4% for LT-02(p=0.098). Furthermore, the safety profile was very favorable.
These promising results led to the study of LT-02 in phase III trials. Three phase III trials for LT-02 in UC have been initiated, PROTECT-1 (NCT02142725), PROTECT-2 (NCT02280629), and PROTECT-3 (NCT 02849951). PROTECT-1 investigated LT-02 at two doses compared to placebo for remission induction in patients with UC refractory to mesalamine, but was unfortunately terminated. PROTECT-2 is investigating LT-02 at the 3.2g dose for maintenance of remission over 48 weeks, and is currently recruiting. PROTECT-3 investigated LT-02 as an add-on therapy for the induction of remission in UC patients refractory to mesalamine, but unfortunately has also been terminated. Given the termination of two studies aimed at induction of remission, it is reasonable to deduct that LT-02 may have more promise as maintenance therapy with a favorable safety profile for UC patients already having achieved remission.
Moderator Ulcerative Colitis
John, UC Proctosigmoiditis in Remission
Rx: Remicade @5mgs/kg/6wks; 50mgs 6MP; nightly RowasaI knew I was in for trouble when my bowels started making the same noises that alien from the movie Predator (1987) did...
Post Edited (iPoop) : 10/11/2019 6:15:31 AM (GMT-6)