Biotech Analysis Central Pharma News: Menlo's Failure, Trevena's Documents, Affimed Halts Studies

by: Terry Chrisomalis


Menlo suffers second major blow after drug fails another mid-stage study.

Trevena's briefing documents cause the FDA to remain cautious on the safety front.

Affimed halts two phase 1 studies upon finding major safety issues.

Welcome to Biotech Analysis Central Daily News, a daily news report and analysis about what has happened lately in the biotech industry.

Menlo Suffers Second Major Blow After Drug Fails Another Mid-Stage Study

News: Recently, Menlo Therapeutics (MNLO) announced that it had failed its phase 2 study treating chronic cough patients with its drug serlopitant. This involves results from the phase 2 study known as MTI-110 (TUSSIX), treating patients with refractory chronic cough. The study failed on both the primary and secondary endpoints. The primary endpoint was to see if there was a change from baseline in 24-hour cough frequency after 12-weeks of treatment between serlopitant and placebo. Patients treated with serlopitant had 31% less reduction than those of the placebo group. For the secondary endpoint 44% of treated serlopitant patients and 54% of placebo treated patients, experienced a greater than 30% or greater reduction in 24-hour cough frequency at week 12 compared to baseline. What does all this data mean? In essence placebo beat serlopitant in all endpoints of the study. Those treated with serlopitant fared worse than placebo.

Analysis: This is very bad news for Menlo Therapeutics. That's because this comes many months after it had failed its key phase 2 study using serlopitant in treating patients with pruritus (itching) associated with atopic dermatitis. This itching study was a failure, and now this chronic cough study failing as well doesn't instill any confidence going forward. Menlo has a catalyst approaching that may turn things around, but at this point any success for this next study is highly questionable. This involves the phase 2 study treating patients with pruritus associated with psoriasis using serlopitant. Results from this study are expected by December of 2018, but after these recent failures I don't have high confidence of this trial being successful.

Trevena's Briefing Documents Cause the FDA To Remain Cautious On The Safety Front

News: Recently, the briefing documents for Trevena's pain drug known as Olivant (oliceridine) were released. As soon as the briefing documents were released, the stock tumbled. Trevena's stock closed lower for the day by 64% to $1.07 per share. The briefing documents are the first step, and what is in there shows that there is a cautious tone from the FDA. However, the same can be said about every other briefing document that has been released by the FDA. By nature the FDA never wants to exhibit that it is biased or bullish towards a particular drug. It has to take that negative tone to show that it is impartial in its final decision.

Analysis: The most notable problem from the briefing documents is that both the low and high doses of oliceridine had similar safety and efficacy conclusions. In essence, there was no differential observed in terms of respiratory safety, nor in other safety issues among other mu receptor drugs. What I did notice in the briefing is that there is an overall tone of oliceridine being equivalent to morphine in both safety and efficacy. What does that mean? That means in essence these briefing documents don't sway me in one way or the other for now. I have to await the FDA adcom panel to make a final basis on how it feels about the safety/efficacy of oliceridine. That means the FDA decision will likely boil down to whether or not it wants to approve another drug to treat patients with pain that is similar to morphine. This is where I believe that it's possible the panel vote may turn out better than anticipated. I don't expect an overwhelming majority for a "yes" vote, but I do expect that possibly half the panel members could be for recommending approval. This notion is based on the fact that morphine is no saint either. Morphine is also susceptible to abuse potential. Patients are given morphine to reduce pain, but it also has a host of side effects and abuse potential associated with it. That means it wouldn't make sense for the FDA to reject oliceridine for abuse potential if morphine has similar capability in that regards. The only way I can see the FDA rejecting the drug is if they feel that morphine is adequate enough, and another drug on the market like oliceridine is not needed. That's why I feel this vote is close, and it will likely depend upon the upcoming Adcom panel this Thursday on whether or not the FDA will decide to approve the drug.

Affimed Halts Two Phase 1 Studies Upon Finding Major Safety Issues

News: Recently, Affimed (AFMD) announced that it had to halt two phase 1 studies due to safety issues. In one of the phase 1 studies, where patients were being treated for acute lymphoblastic leukemia, a patient had died. In the other phase 1 study, where patients were being treated for non-Hodgkin Lymphoma (NHL), two patients experienced life-threatening issues. The company noted that the higher dose of AFM11 may have been the root cause, that is still being investigated. AFM11 is Affimed's CD3 engager drug program. The stock closed lower by 24.41% to $3.50 per share based on this news.

Analysis: The future for the AFM11 program seems to be in jeopardy for now. The reason why I state for now is because information from both phase 1 studies will need to be analyzed to determine the root cause for the deaths and safety issues noted in the studies. A majority of the time, patients dying in trials have nothing to do with the drug itself just that the patient is very sick. I don't want to highly speculate this is the case at this time, but there's a chance that this program may be revived. It will likely take a few weeks/months to actually determine what actually transpired with these patients. On the flip side, there is a good outcome out of this newly released news. The positive outcome being that AFM13 is not affected. Why is that important? That's because back in August of 2018, Affimed made a deal with Roche (OTCQX:RHHBY) for its AFM13 candidate totaling over $5 billion. Affimed has already received an upfront payment of $96 million for this deal. The reasoning is because AFM13 recognizes CD30 and binds to high affinity natural killer (NK) cells. On the other hand, AFM11 goes after T-cells through CD3 and recognizes CD19 on tumors. I think the most notable news out of this situation is that the partnership between Affimed and Roche for AFM13 is and will remain intact.

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