On July 22, 2015 shares of Biogen fell about 4% after reporting mixed results for its Alzheimer’s drug known as aducanumab. This phase 1b trial was known as the “PRIME” trial and patients were randomized into two different dosing groups. One group of patients either took 1 mg, 3 mg , 6 mg or 10 mg of aducanumab, while the other group of patients were given a placebo drug instead. Biogen had obtained positive results beforehand in the 3 mg group and the 10 mg group, but failed to produce similar results in the 6 mg group of patients that took aducanumab.
The problem was that the 6 mg dose of aducanumab did not deliver the same good news as the other doses did. Although one thing to note is that the 1 mg dose of aducanumab was similar to placebo, so that was a complete wash. What Biogen reported was that the 6 mg dose of aducanumab was able to reduce the amount of the beta amyloid plaques in patients at a 52-week time point, but was unable to improve cognitive problems in patients with Alzheimer’s.
This is because in order to treat the underlying problem of Alzheimer’s patients must see an improvement in cognition. Right now there is no 100% proof that reducing beta amyloid plaques correlates to an improvement in cognition for these patients.
Big pharma giant Eli Lilly (NYSE:LLY) on the other hand reported partially better results than Biogen did. Although one thing to note is that Eli Lilly’s trial is currently in phase 3 clinical testing, while Biogen’s results were only in phase 1b testing. Eli Lilly’s drug though solanezumab was actually able to improve cognitive effects in patients with Alzheimer’s. Then why were investors and Doctors not as impressed with Eli Lilly’s results?
This is because Eli Lilly ran two trials and observed some patients that took their drug early compared to those that took the drug later. They noticed that those who took the drug earlier benefited more than those who took the drug later. This is because solanezumab was able to reduce a cognitive decline in these patients with Alzheimer’s. The problem though is that a doctor proclaimed that you can’t obtain proper efficacy by comparing one trial that started an earlier time point compared to another trial that started at a later time point.
The other problem with Eli Lilly’s drug solanezumab was that it was given to patients with mild Alzheimer’s disease. That means that these patients probably had just started to show symptoms, therefore efficacy against advanced patients with Alzheimer’s was not observed with this drug compound.
These two big pharma giants that had moderate results in Alzheimer’s. If any big pharma company can obtain good results than it is potential market opportunity of $20 billion. There was one company which performed a small study but obtained better results in patients with Alzheimer’s. This company is known as Anavex Life Sciences Corp. (OTCMKTS:AVXL) and they released positive phase 2a results in their Alzheimer’s trial.
This phase 2a trial is enrolling 32 patients in total, but the results only stem from the first 12 patients. At least 10 out of 12 patients achieved positive cognitive effects for their Alzheimer’s — translates to about 83% of the patients. More specifically those patients taking Anavex’s drug Anavex 2-73 saw a 38% improvement from baseline. A 38% increase from baseline is four times greater than donepezil — marketed under the name Aricept — which is the current standard of care for Alzheimer’s patients.
Keep in mind though that this was only the first 12 patients of the study so the data is small and preliminary in nature. Despite that though if Anavex releases the full phase 2a results at a later time point and are the same as these results then this will continue to take off to a higher share price.
Inotek Pharmaceuticals (NASDAQ:ITEK)
On July 23, 2015 Inotek shares soared 193.88% after the company announced that it had met with the FDA for an end of phase 2 meeting. This meeting was held and the company announced that the FDA had approved the company for a phase 3 trial for patients with Glaucoma. The pivotal phase 3 trial will use the company’s drug Trabodenoson to treat these patients with Glaucoma.
The phase 3 trial is expected to start sometime in Q4 2015, and then possibly the company will make available some early clinical results in 2016. Early phase 2 results were very encouraging where efficacy was observed in these patients at both the 200 mg and 500 mg doses. That is that these patients with Glaucoma saw a reduction of intraocular pressure of their eyes in both of these doses. Those patients in the 500 mg group continue to see improvement of intraocular pressure reduction 28 days post treatment.
The next phase 3 trial will once again compare Inotek’s drug Trabodenoson against a placebo compound to determine which drug produces greater efficacy. This time around it may be easier as the company may experiment with multiple dosing, instead of single dosing. It is quite possible that multiple doses may yield far robust efficacy compared to a single dose and the placebo compound itself. It would be wise to keep an eye on Inotek for possible future gains.
Xoma Corporation (NASDAQ:XOMA)
On July 22, 2015 shares of Xoma tanked 77.25% after the company announced that it failed a phase 3 trial in patients with a rare eye disease known as Behcet’s disease Uveitis. The phase 3 trial was known as the “EYEGUARD-B” trial and it was run together with a French Pharmaceutical company known as Servier. In order to treat this rare eye disease patients were given Xoma’s drug known as gevokizumab.
The phase 3 trial failed to meet on the primary endpoint of the study but the company claimed that there were some other minor improvement observed with the patients that took the company’s drug. The primary endpoint was for the drug, gevokizumab, to reduce inflammation of the eyes in these patients. Xoma must now await for the full data to determine the next course of action for this drug compound but it is not likely that the company will be able to move on for FDA approval of this product.
Xoma does have other clinical products in the pipeline but they are early in nature and there is no guarantee that any of these will achieve success in the coming years. For now we recommend that investors avoid Xoma at all costs. Shares have been on a decline since the company announced the failed results last week dropping an additional 17% the past 3 trading days.